Pfizer

Nervous system symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2020-12-31 flushing I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Ligh... Read more
I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.
60 2021-01-01 feeling of body temperature change, tremor Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling h... Read more
Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold
60 2021-01-03 feeling cold * Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, ... Read more
* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight
60 2021-01-03 weakness Debilitating frontal headache, accompanied by nausea and vomiting, and fatigue for 16 hours
60 2021-01-03 pain in extremity Flu-like symptoms - nausea, sweat. Arm sore immediately after injection - sore for 2 days.
60 2021-01-04 facial paralysis, slurring Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her hist... Read more
Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.
60 2021-01-04 weakness, muscle spasms Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation... Read more
Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
60 2021-01-04 tingling, flushing Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a littl... Read more
Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a little throat tightness after initial monitoring period of 15 minutes. Occurred 1-2 hours after dose admin. Resolved with no treatment, though Benadryl was recommended.
60 2021-01-04 flushing Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a... Read more
Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.
60 2021-01-04 muscle spasms Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm c... Read more
Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.
60 2021-01-04 feeling cold generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run do... Read more
generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
60 2021-01-04 weakness, hot flush tired Chills Muscle aches Throat irritation weakness no energy hot flashes
60 2021-01-05 tingling Dizziness, tingling, possible anxiety attack
60 2021-01-05 pain in extremity Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in b... Read more
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
60 2021-01-05 pain in extremity On day 1 after the vaccine the employee began having muscle aches and sore joints. By day 4 she fel... Read more
On day 1 after the vaccine the employee began having muscle aches and sore joints. By day 4 she felt like she had an improvement in symptoms. On day 6 the same symptoms reappeared and the employee was tested for COVID (negative PCR). She reports that all of her joints in bilateral upper and lower extremities are extremely sore, she noted that "even her toes were painful". She is unable to take NSAIDS because of a history of anaphylactic reaction to Motrin in the past.
60 2021-01-05 flushing Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse Al... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021   Date: 1/6/2021 MRN: 3274958   Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020   PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours.     ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness       Objective   Vitals Vitals:   01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 °F (37.3 °C) SpO2: 100% BS 94 at 12:38   Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm     APRN Electronically Signed 1/6/2021 12:45 PM    
60 2021-01-05 pain in extremity Sore arm lasting 24-48 hours. Ibuprofen
60 2021-01-05 tingling Tingling of toes and finger on the on side of body vaccine occurred, light headed, HEAD ACHE
60 2021-01-05 flushing, burning sensation dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to... Read more
dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
60 2021-01-06 cold extremities, flushing, tingling, numbness 30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some a... Read more
30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.
60 2021-01-06 tremor Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self ... Read more
Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self medicated with Motrin with some improvement of symptoms.
60 2021-01-07 numbness, tingling Approximately 20 minutes post injection patient felt tingling/numbness in the left pinkie finger, mi... Read more
Approximately 20 minutes post injection patient felt tingling/numbness in the left pinkie finger, migrated to right pinkie finger with one hours. Acetaminophen
60 2021-01-07 flushing, tingling Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD... Read more
Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.
60 2021-01-07 muscle spasms Mild shortness of breath Severe bil lower extremity muscle spasms/cramps
60 2021-01-07 difficulty speaking Pfizer-BioNTech COVID-19 Vaccine Patient received Pfizer Covid-19 vaccine at 1043. Patient compl... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient received Pfizer Covid-19 vaccine at 1043. Patient complained of tingling throat, no swelling noted. Patient alert, oriented and talking/answering questions appropriately. Voice noted to become hoarse with continued conversation. EMS alerted and took over care at 1107.
60 2021-01-07 pain in extremity arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on he... Read more
arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol. The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy. The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, "I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy."
60 2021-01-09 weakness Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improve... Read more
Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.
60 2021-01-09 migraine HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35... Read more
HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35 PM B/P 185/98 PR 60 @11:45 NO N/V NO CHEAT PAIN
60 2021-01-10 feeling hot 1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to t... Read more
1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading
60 2021-01-10 feeling cold COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th ... Read more
COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.
60 2021-01-10 feeling hot Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms... Read more
Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms get better.
60 2021-01-10 inability to speak Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache... Read more
Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
60 2021-01-10 discomfort, tremor Pressure in my head behind my ears. Clear drainage from my nose. Feeling shaky has been going on for... Read more
Pressure in my head behind my ears. Clear drainage from my nose. Feeling shaky has been going on for past 15 days. Due for second dose afraid to take it.
60 2021-01-10 feeling hot, weakness, pain in extremity She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion ... Read more
She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F
60 2021-01-10 weakness four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and incre... Read more
four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls
60 2021-01-10 weakness nausea,weakness,chills , fever , muscle and joint pain , no appetite
60 2021-01-11 pain in extremity Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheez... Read more
Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.
60 2021-01-11 cold sweat Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat an... Read more
Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest
60 2021-01-11 tremor TEMP 99 AFTER TYLENOL s shaking chills
60 2021-01-11 pain in extremity developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tyleno... Read more
developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tylenol, used heating pad
60 2021-01-11 flushing the patient began to experience dizziness and flushing; the patient began to experience dizziness an... Read more
the patient began to experience dizziness and flushing; the patient began to experience dizziness and flushing; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The female patient who was seen at (Clinic name) today on 06Jan2021 for her second dose of the COVID 19 vaccination. During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing on 06Jan2021. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness. The outcome of the events was unknown. This case was reported as non-serious. No follow-up attempts are possible. No further information is expected.
60 2021-01-12 tingling At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following we... Read more
At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following week, as far as I can recall, I began to have tingling from the right shoulder blade down to my hand. I thought I may have a pinched nerve and went to the walk in clinic to be seen by the nurse practitioner that is in the same office as my primary. She examined me and thought it sounded like a pinched nerve and said I was swollen in the area of complaint. Cervical and thoracic x rays were taken (normal) and was told to take Flexeril and steroids. Pain was getting worse and primary told me to begin taking Meloxicam and have physical therapy. I have been doing both beginning 1-11-2021. Pain continues with no improvement. Do not know if my symptoms are caused from the Covid shot, but just seemed to me that it was quite a coincidence that muscle pain began on the same day as receiving the shot.
60 2021-01-12 pain in extremity Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous r... Read more
Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (arm left) on 08Dec2020 (lot unknown) at SINGLE DOSE; and second dose via an unspecified route of administration on 06Jan2021 at SINGLE DOSE (lot number EJ1685) for COVID-19 immunization. The patient medical history was not reported. The patient was taking unspecified concomitant medications (same medications that she usually takes and has not started anything new). Patient reported that she was fine after the first shot. Her arm was a little sore on Dec2020 and that was it. The soreness at the injection site lasted 2 days and then recovered completely. She has no breathing difficulties or anything similar. Outcome of the event "Her arm was a little sore" was unknown while recovered for " The soreness at the injection site lasted 2 days" on Dec2020.
60 2021-01-12 difficulty speaking Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started hav... Read more
Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started having mild itching in my trunk, arms and left Hand. itching increased so took Benadryl 50 mg PO, stayed for 15 minutes then left work to go home. Once home itching increased, eyes started swelling and started losing my voice. Husband took me to the ER at Hospital, arrived approx. 6.10 pm. Treated with Benadryl, Solu medrol and Pepcid, all thru IV. Condition improved and client sent home with script for Pepcid, Medrol dose pack and Atarax.
60 2021-01-12 migraine Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; ... Read more
Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 04Jan2021 14:56 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, previously had an allergic reaction to just one antibiotic. Concomitant medication included nifedipine, carvedilol. Consumer stated, "About 15 minutes into after getting the injection, I was sitting to the site they asked me to stay longer because I previously had an allergic reaction to just one antibiotic (Unspecified Medication).So that was within the 15 minute mark I started getting ringing in my ears and at the 20 mark I had migraine. I had them since I was about 9, they were diagnosed, it triggered a migraine. Although the ringing had gotten better in the last year but it is really bad in the right and it is now causing me (incomplete sentence)." Consumer stated, "I am probably say like I am yelling at you. I cannot hear and my son keeps telling me mom you are yelling. I did not see that I am 'ringing to your sheath' ringing in the ear, the headache. I just see my headache is better today. I had a little bit of it but nothing you know Excedrin or something would take care of not enough for me to go take that but it is the ringing and I cannot hear out of that ear. I put my phone up and ringed up. Consumer stated, "Recently my mom had COVID (further not clarified), I barely heard it. On the 23rd of Dec and I keep in contact with my family,they are 13 of us and I picked up the phone and instinctively put it to my right ear, I could not hear and I kept looking at the phone and I thought wait a minute and I put it to my left seems to be okay. It is the right I cannot hear." Consumer further added, "I am a Nurse so you expect this, that is why I waited this long because I got the injection at like 3 O'clock yesterday and I waited even longer thinking maybe it will just go away and So I know you guys want to know everything that is going on. So I said wise better to call." Date of vaccination: Consumer stated, "04Jan2021 (Clarified as 04Jan2021) and the time was 2:56 PM." Consumer further added, "It is the only thing I could think of. It is the only thing that I could think of that I did differently out of my daily habits to go get this injection. I would say within 15 minutes it just started turning my head and I was like wait a minute I am having ringing and then they had music playing above our head, it sounded like everything was muffled then I turn my head to the right I could hear better and they kept turning my head and one of the administrators at the table started looking at me so I get up and I said you know what I am having ringing in my ear so they had me seated there a bit longer." Dose and route of administration: Consumer stated, "I think she pulled up one cc that I saw and I got it in my left deltoid." Treatment: Consumer stated, "No." Causality: Consumer stated, "I would have to say because it started like say in the 15 minute mark and then the headache came in about 20 minute mark." The outcome of the event Headache was resolved while the outcome of the other events was unknown.
60 2021-01-12 pain in extremity The day after my arm was very soar for at least 48 hours, no fever just laying around. I had low ene... Read more
The day after my arm was very soar for at least 48 hours, no fever just laying around. I had low energy for about three weeks and I'm just now feeling better. Around the 26th my lymph nodes swelled up (three of them) . I called my PCP, he told me to take Tylenol is painful and to put warm compress if they were uncomfortable. They are still there, they don't hurt or painful.
60 2021-01-13 tingling Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained ... Read more
Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained of head tingling and body itchiness.
60 2021-01-13 muscle spasms Received 2nd dose Pfizer lot EL0142 in right arm on 1-13-2021. Employee is experiencing body aches ... Read more
Received 2nd dose Pfizer lot EL0142 in right arm on 1-13-2021. Employee is experiencing body aches and cramping all over.
60 2021-01-13 flushing, cold extremities, tingling, pain in extremity, feeling hot flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness... Read more
flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness in the arm; little headache; experiencing tingling in hands and feet (mostly in feet); experiencing tingling in hands and feet (mostly in feet) and they feel cold; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route on left upper arm at single dose for COVID-19 immunization on 05Jan2021, 12:30pm at 60-year-old. Medical history included: ongoing diabetes type 2; ongoing gout; went through menopause 10 years ago (2011). She had pulmonary emboli 3 years ago (2018) and had some scar tissue but not on oxygen though she did get short of breath. No relevant family medical history. The only reactions she has ever had was 15 years ago (2006), she had a CAT scan and experienced hives the next day due to the contrast medium. She thought it had since been changed as she had had it twice since then and was given diphenhydramine hydrochloride (BENADRYL) but experienced nothing again. Concomitant medication included: ongoing dulaglutide (TRULICITY) for diabetes type 2 and ongoing oral medication (unspecified) for gout. No additional vaccines administered on same date of BNT162B2. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) single dose for COVID-19 immunization on 19Dec2020 around 12pm and 2 pm. The patient previously got the flu shot (unspecified) every year, 3 years ago (in 2018) she got the shingles vaccine and had also had the pneumonia vaccine (in 2018) but never experienced anything from those products. The patient previously took allopurinol for pulmonary emboli and had had no reoccurrence. She took warfarin for short of breath. The patient had flushing on 05Jan2021, she was hot and turned red like a cherry. She had an episode where she felt really hot like hot flashes or almost like she was flushed. Her face was red as beet and her arm and hands were red, this lasted about an hour and she took ibuprofen (ADVIL) for it. It seemed to be resolved but had come and gone through the night. She was up checking on her puppies so that was how she noticed. She had taken her temperature and it had been 97.6-98.1 which was normal for her, but she was still getting the hot flashes and flushing. She felt feverish and it was not a rash, she just felt flushed. After the vaccine, the patient reported soreness in the arm on 05Jan2021. The patient was experiencing tingling in hands and feet (mostly in feet) on 05Jan2021 and they feel cold. Tingling started about 45 minutes to an hour after the dose. The first time lasted 3-4 hours and then went away. It came back in the middle of the night for a couple hours and then again this morning. This morning it had been going on for 2-3 hours and was still going on right now; it started about 6:30am-7am. They feel cold but her feet were really cold. She had socks and slippers on, but they didn't seem to get warm. She went on to explain that her hands and feet have profusion. During this she had checked her pulse ox (oximetry) related to her cold hands and it had been 92-95% (on unknown date) which was good. She had also checked her pedal pulses even though they were cold, and a little they were a little on white side, they blanch although might be a little slow but nothing alarming. The patient had a little headache on 05Jan2021. Other than that, the patient felt fine. No emergency room or physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events flushing, hot/ felt really hot, soreness in the arm, tingling in hands and feet (mostly in feet) and they feel cold was not resolved; outcome of the other events was unknown. Causality assessment between the Pfizer product (BNT162B2) and the events (tingling, flushing, soreness in the arm) per the reporter was reported as related.
60 2021-01-14 muscle spasms, pain in extremity 1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heavine... Read more
1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heaviness from belly button down to the legs. Advised to go to the EC for evaluation. Update 1/15: Seen in ED and had EKG with inverted T wave. Still has heaviness in legs. Will get a referral to cardiology after speaking with PCP.
60 2021-01-14 discomfort Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus,... Read more
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.
60 2021-01-14 pain in extremity I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in... Read more
I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.
60 2021-01-14 feeling hot Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection... Read more
Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.
60 2021-01-14 pain in extremity left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weake... Read more
left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weakening her joints on those extremities/ shoulder pain; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: unknown), via an unspecified route of administration, on 16Dec220, at a single dose on arm right for COVID-19 immunization. Medical history included diabetes mellitus 2, hypertension (HTN), migraines, back pains, hypothyroidism, and allergies to latex and kiwi. The patient received the vaccine at a military base. She did not receive other vaccines in four weeks. The patient was not pregnant at the time of vaccination. She had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified medications; she received other medications in two weeks. The patient previously took gabapentin and topiramate (TOPAMAX), in which she experienced allergies. On the second day after receiving the vaccine, 18Dec2020 04:00 AM, the patient started feeling left neck moderate to severe pain, and the pain started radiating down her left arm and down left leg, weakening her joints on those extremities. This continued severely for 3 days. At this time, she continued to feel mild left neck, shoulder and arm pain intermittently. She could not report this immediately due to not having her vaccine documents which she forgot at her workplace as she proceeded to vacation. She had paused in getting the second dose that was due on 07Jan2021, waiting to hear from Pfizer. The patient received NSAIDS and Muscle relaxant medications as treatment for the reported adverse events. Outcome of the events was recovering.
60 2021-01-14 weakness reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports wea... Read more
reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports weakness,
60 2021-01-15 pain in extremity Arm and joint pain, itching, rash
60 2021-01-15 difficulty speaking, tingling I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor ... Read more
I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor difficulty breathing. I had an increased you can buildup up in my throat and nose, with coughing. I took two Benadryl; about 45 minutes later my breathing improved. I took the Benadryl at 8:15 AM. It?s now 2:25 PM and my eyes are getting itchy and starting to feel puffy again. My voice is still very hoarse.
60 2021-01-15 pain in extremity, numbness Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thy... Read more
Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thyroid medicine before going to before at midnight; very restless night of sleep. The pain in my arm woke me up. I never felt like I fell asleep. I woke up at 530am and took my Thyroid medicine and went back to bed until 6:30am. Felt fine until about 830am. I noticed I was starting to feel lightheaded and had this pressure on my head. I went back to bed and tried to fall asleep but really never did. I noticed that I would lose track of my train of thought often. Got up at 11am and took a shower and still just didn't feel like I had any motivation to do anything, so rested again. I then noticed my face, ear lopes and cheeks felt a little numb. I would pinch them and I noticed they were numb. Also, there was still pressure on the back of my head and on the bridge of my nose. Still light headed. I layed in bed until about 3pm when I did notice the numbness going away and the pressure on the back of my head and on the bridge of my nose getting a little better. Also, no appetite.
60 2021-01-16 flushing, pain in extremity Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: ... Read more
Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.
60 2021-01-16 numbness, tingling Within 15 mins of receiving the vaccine I had slight tingling in my R cheek. Within 2 hrs of the vac... Read more
Within 15 mins of receiving the vaccine I had slight tingling in my R cheek. Within 2 hrs of the vaccine I had R facial numbness from maxillary to ear and lower jaw. Within 6 1/2 hrs from the vaccine, I had R lateral calf numbness. Within 8 hrs of the vaccine, I had R hand and arm numbness, R side of mouth and tip of tongue numb, R orbital swelling, scratchy R eye, maxillary tenderness. Advil was taken 9 1/2 hrs after the vaccine. Symptoms improved by next am, and gone by 24 hrs post vaccine.
60 2021-01-17 cold sweat Clammy, sweating and rash to BUE and chest. Patient will be seeing PCP for treatment.
60 2021-01-17 muscle spasms Left upper eyelid spasming several times an hour day and night for about 10 days, then starting to l... Read more
Left upper eyelid spasming several times an hour day and night for about 10 days, then starting to lessen to every couple of hours day and night
60 2021-01-17 pain in extremity SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT M... Read more
SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT MORNING. ALL LASTED UNTIL ABOUT 28 HRS POST VACCINE.
60 2021-01-17 numbness limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her bo... Read more
limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;
60 2021-01-18 flushing Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and fo... Read more
Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening
60 2021-01-18 tremor Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Head... Read more
Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.
60 2021-01-18 slurring Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupil... Read more
Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupils, and was slow to respond to questions. Patient felt "foggy," similar to waking up from anesthesia.
60 2021-01-18 tingling began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and ras... Read more
began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face
60 2021-01-18 feeling hot fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt rea... Read more
fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension. Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.
60 2021-01-19 bell's palsy Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. To... Read more
Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching
60 2021-01-19 cold sweat Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS ... Read more
Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours
60 2021-01-19 weakness, feeling hot Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart ra... Read more
Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.
60 2021-01-19 flushing chills, headache, body aches, loss of taste, flush, red eyes, extreme fatigue
60 2021-01-20 pain in extremity Sore arm vomiting diarrhea muscle pain pain in the neck to the shoulders
60 2021-01-20 weakness, hot flush Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up i... Read more
Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.
60 2021-01-20 pain in extremity received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working after... Read more
received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working afternoon progressed to chills and total body aches. temp 101 through evening up and down after motrin to next day Wednesday. wednesday had some chills but during night into Thursday had joint pain no fever. woken up thursday with joint pain and headache no fever.
60 2021-01-20 pain in extremity taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the co... Read more
taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
60 2021-01-21 feeling hot INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of... Read more
INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs- no fever
60 2021-01-21 tingling Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her r... Read more
Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her right hand was pale. + tingling. Brought to be evaluated by EMT.
60 2021-01-21 pain in extremity Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs afte... Read more
Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs after vaccination and lasted approximately 36 hours.
60 2021-01-23 tremor developed muscle tremors, ataxia, unable to walk, nausea
60 2021-01-24 feeling hot, tremor 12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours l... Read more
12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
60 2021-01-24 feeling cold Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at s... Read more
Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days
60 2021-01-24 tremor, muscle spasms Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; T... Read more
Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-01-24 weakness, pain in extremity, burning sensation Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate... Read more
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-01-25 pain in extremity Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizz... Read more
Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.
60 2021-01-25 slurring Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/... Read more
Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/92
60 2021-01-25 slurring The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, s... Read more
The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, she felt dizziness, her head was spinning, weakness of the arms, and slurred speech. Her FS was at 108 (Normal), BP 195/105 (Extremely high), Pulse 91, O2 saturation was at 100%. At 2:48PM, her BP lowered to 167/92. At this time, she can smile, she can put her hands up, she can kick her feet and she can opened/closed her eyes. Due to her high BP, Doctor requested that the should go to the ER via the ambulance.
60 2021-01-25 pain in extremity sore arm; This is a spontaneous report from a contactable nurse (patient). This 60-year-old female p... Read more
sore arm; This is a spontaneous report from a contactable nurse (patient). This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 19Dec2020 for COVID-19 immunization. Medical history included asthma; hypertension; acid reflux; food allergies; known allergies to peanut, shell fish, IVP dye, penicillin and tree nuts. Patient also had known allergies to erythromycin and ceftriaxone (ROCEPHIN). Concomitant medication was not reported. There was no other vaccine in four weeks. On the first dose of 19Dec2020 just a sore arm (date unspecified). The outcome of event was unknown. Information on lot/batch no. has been requested.
60 2021-01-26 muscle spasms, numbness C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccin... Read more
C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids
60 2021-01-26 pain in extremity Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that c... Read more
Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.
60 2021-01-26 pain in extremity First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and ... Read more
First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.
60 2021-01-26 pain in extremity There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose o... Read more
There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose on 1/9/21: Approximately 53 hours after Dose #1: Redness on hands and wrist, rash-like small dot appearance on hands and wrists, skin dryness and tightness of hands. I experienced no itching of hands or wrists. Approximately 53 hours after Dose #2: Small, painful red pustule-like occurrence on base of right thumb, with the appearance of a few small dots in it. I experienced no itching of thumb or hand. These events both occurred within the same timeframe following the vaccine doses. Following the first event I was seen in the ER. I checked out fine and they could not say exactly what this was. They said it did not appear to be an allergic reaction to the vaccine because it was not systemic and I had no other symptoms such as trouble breathing. They thought perhaps it was coincidental...I work in the hospital as a radiologic technologist where I hand-wash and hand-sanitize all day. Perhaps I just over-washed that day? However I've worked there for 17 years and never had this happen. The redness and rash dissipated by end of day. Following the second event I did not follow up with any medical provider. This pustule I got happened while I was at home, and otherwise I felt fine so I left it at that. It took several days for the pustule to go away. I hope you don't mind but I am writing to report this information in the event it may be helpful to you and I am also reporting it because I want to know if what I experienced could be considered an immune response to the vaccine? Another words, not an allergic response but an immune response ? I can find absolutely nothing about this on-line and no one knows what to make of it. Thank you.
60 2021-01-27 pain in extremity Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes... Read more
Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes of each other and now to be re-vaccinated again the second dose; not enough research can guarantee if that's safe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140, expiry:Mar2021), intramuscular on 12Jan2021 at a SINGLE DOSE then intramuscular on 12Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased, fistula, surgery on 18Dec2020. It was stated, "Sure, I am hoping you can help me. I am one of the legal guardians for our younger sister who has special needs. She is residing in a group home, group home in the city area she is currently been out of it because she has surgery. They have made arrangements for them to still ask for them to receive the first Pfizer Covid 19 Vaccination just this past Tuesday so I go from up there from my home in city and we had a problem in there they screwed up and ended up vaccinating her twice within 10 minutes. I asked the pharmacist, there I asked the RN what does that mean for her I mean I didn't know what that meant but normally we would sat for 15 minutes, they made her sat for 30 minutes. The nurse was there from the group home monitored her blood pressure and temperature and then we got in the car proceeded to drive 3 and half hour. They said just watch for temperature, labored breathing, take her to the emergency room call 911, the only thing she did have about an hour after she broke out that was "malar" (not clarified) rash across her face part of her cheeks over her nose that lasted for about 30 minutes. The next day her arm was sore which was going to happen but here is my question though she received two vaccine within 10 minutes of each other and now they are wanting her to be re-vaccinated again which would have been the second dose, supposedly on 02Feb2021. Nobody can tell me if that's safe or if that's okay, they can't guarantee, they all kept telling me, the nurse says, I called the pharmacist kept saying there's not been enough research to know if it's safe for her to get that next vaccine, so I don't know what to do." The reporter also stated, "IM, Both went for IM, first one went into her left arm and second shot was given in her right arm." The patient underwent lab tests and procedures which included blood pressure measurement: unknown result on an unspecified date, blood test: unknown result on 05Jan2021, body temperature: unknown result on an unspecified date, sars-cov-2 test: unknown results pre-surgery and post-surgery. The outcome of the event rash across face, part of her cheeks over her nose was recovered and arm sore was unknown.
60 2021-01-27 cold sweat Red, warm rash around injection site cold sweat, chills, and swelling to Left arm
60 2021-01-27 numbness, pain in extremity Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritat... Read more
Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.
60 2021-01-27 pain in extremity arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, ... Read more
arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.
60 2021-01-28 tenderness, hot flush FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT C... Read more
FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.
60 2021-01-28 tremor, weakness Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneo... Read more
Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
60 2021-01-28 pain in extremity, weakness, migraine day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling cru... Read more
day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......
60 2021-01-29 feeling cold Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt ... Read more
Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt fine the next morning.
60 2021-01-31 tingling 6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days... Read more
6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.
60 2021-02-03 weakness, pain in extremity Right upper arm/shoulder pain, including pain within joint. Limitations to move arm and weakness co... Read more
Right upper arm/shoulder pain, including pain within joint. Limitations to move arm and weakness continue even after 1 month.
60 2021-02-03 feeling cold chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a c... Read more
chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 11Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included citalopram, topiramate, zinc, and ergocalciferol (VIT D). On 12Jan2021 07:00, the patient started having chills in the morning that was gradually increasing throughout day. At 6:00pm, that patient had major chills and could not warm up. The patient got into the bed with numerous covers. She was cold all night. The last time she woke up was at 3:00am, and then when she woke at 6:00am, and she was fine. No treatment was received for feeling cold. Clinical outcome of the events was recovered on an unspecified date. Information about lot/batch number has been requested.
60 2021-02-03 flushing light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healt... Read more
light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks. On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.
60 2021-02-03 slurring slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupil... Read more
slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupils; "foggy."; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), intramuscular on 19Jan2021 09:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and oedema. Concomitant medication included phentermine hydrochloride (ADIPEX-P), olmesartan medoxomil (BENICAR), furosemide (LASIX), amlodipine besilate (NORVASC), doxycycline (VIBRAMYCIN). The patient previously took Ciprofloxacin, Clopidogrel, Meperidine, Flagyl, Macrobid, Penbutolol and experienced drug hypersensitivity. The patient had the first dose of vaccine on 20Dec2020 (Lot number=EK5730). The patient exhibited slurred speech, dilated pupils and responded slowly to questions within 2 hours of receiving the vaccine. The patient felt like she just woke up from anesthesia and was "foggy" and 19Jan2021. The outcome of the events was unknown.
60 2021-02-04 tremor 1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that da... Read more
1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'
60 2021-02-04 pain in extremity 12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache o... Read more
12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.
60 2021-02-04 pain in extremity Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache w... Read more
Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.
60 2021-02-05 flushing Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 ... Read more
Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 97% Lungs clear.Client called family to pick her up and take to her PCP.
60 2021-02-06 tremor High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking ... Read more
High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.
60 2021-02-07 pain in extremity high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; ... Read more
high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.
60 2021-02-08 tenderness her face got swollen; lymph node right there it was extremely swollen and very tender and very painf... Read more
her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.
60 2021-02-16 speech disorder Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for... Read more
Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.
60 2021-02-16 difficulty speaking Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccinati... Read more
Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.
60 2021-02-17 tingling, burning sensation, nerve pain, pain in extremity This is a spontaneous report from a contactable consumer. A 60-year-old female patient received sec... Read more
This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, subcutaneous on 20Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included diabetes, anaemia, blood pressure, cholesterol. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EU9899, in the left arm on 30Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization and experienced swelling and redness at the site. Concomitant medications included liraglutide (VICTOZA), labetalol (LABETALOL), diltiazem (DILTIAZEM), valsartan (DIOVAN), rosuvastatin, metformin, aspirin and iron. The patient thinks that it wasn't given to her intramuscularly. This is a potential inadvertent subcutaneous administration of the BNT162B2. This patient received her second dose on 20Jan2021 on the side of her arm and reported that it was swollen, red, and hot, but has gotten 100 times better' over the last 6 days since administration. She was asking for efficacy of the incorrectly administered dose. It was further stated that in the middle of the night, her arm was red almost like a little bullseye and she said that she was getting burning, and pins and needles down her arm, and a fullness in her hand like her hand was swollen. She said that she still kind of feels it. As the days progressed on day 2, 3, and 4, the swelling got more intense, the circular red swollen area got worse to the size of like a small baseball. She was feeling okay other than that. Today was day 6 and it was not as red and was more black and blue, swelling went down 80 percent, she still feels a little bit of the pins and needles and the fullness in her hand. She said that there was like a big knot that was very hot. It was a hard like knot at the injection site. The injection site was really big, round, hot, red, and had a knot that lasted; adds it is still there but 99% better; and she had tingling down her arm with pins and needles in her hand. She noticed it was little red a couple of hours, like 8 hours later; but by the next day it was circular, more red, swollen, itchy, and burning down her arm. By the third day, the site had a big, red, hard knot; still burning down her arm and with pins and needles down her arm. She added that her hand felt like a fullness in her hand filled with fluid. By Friday the swelling at the site was gigantic. The site swelling is improved but the redness was more of a black and blue now. Her arm has been very dark red, discolored, swollen, painful and has nerve pain described as "hot tingling down the arm like pins and needles" to her hand. She states that she has a very large knot at the injection site. This was in her non-dominant arm. She spoke with two of the pharmacists that she works with and they looked at her arm and both felt like she may have received the injection subcutaneously instead of intramuscularly. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
60 2021-02-17 tremor, feeling hot, pain in extremity This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to re... Read more
This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no concomitant medications. The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
60 2021-02-17 cold sweat lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded... Read more
lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
60 2021-02-21 difficulty speaking During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations... Read more
During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.
60 2021-02-21 feeling cold, weakness, pain in extremity Woke up during the night with chills that had my body shivering and a headache. Did not get up unt... Read more
Woke up during the night with chills that had my body shivering and a headache. Did not get up until morning because I didn't want to get out of the covers even though I was cold. Took some ibuprofen which helped with both the chills and headache. I had no energy and was very tired. I slept most of the day and woke up to go to the bathroom and take more ibuprofen. Towards the evening I could tell that I was feeling a bit better. I was able to take a bath, more ibuprofen and went to bed. Slept pretty well. Woke up once and took ibuprofen because of headache and body aches. Felt much better on Sunday. Was still tired and slept a good part of the day. My arm continues to ache, but is not really painful unless I try to lift it.
60 2021-02-23 flushing, numbness Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty brea... Read more
Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty breathing but felt like she had to take off her mask to get "air", slight numbness in the arms and felt flushed.
60 2021-02-23 migraine I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's pos... Read more
I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today
60 2021-02-23 numbness, tingling Other than mild soreness at the injection site she experienced no adverse reactions during the first... Read more
Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation
60 2021-02-24 tingling 1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order ... Read more
1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order received to administer po benadryl 25 mg po 1030 symptoms resolving continued to monitor for additional 30 min. 1100 pt stable and symptoms resolved left premises this time.
60 2021-02-24 pain in extremity, numbness, tingling As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left ar... Read more
As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. I see that COVID-19 biofire came back positive. In light of this, COVID myelopathy is on the differential
60 2021-02-24 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details:... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins
60 2021-02-25 flushing About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed... Read more
About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed. BP was high but otherwise vital signs within normal limits. Symptoms resolved.
60 2021-02-25 tingling Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some... Read more
Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.
60 2021-02-25 difficulty speaking Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2... Read more
Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2 antibiotics. She was given 25 mg of benadryl and symptoms improved. She was given instructions to take more benadryl in 4 hours to help with symptoms and to go to the ED if symptoms got worse
60 2021-02-26 tingling, feeling hot, pain in extremity IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatig... Read more
IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever
60 2021-02-27 hot flush Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Fri... Read more
Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.
60 2021-02-27 pain in extremity, numbness, feeling cold My upper arm started feeling odd ... numbness in my left upper arm. I liken the feeling to when I?m ... Read more
My upper arm started feeling odd ... numbness in my left upper arm. I liken the feeling to when I?m having dental work done and my mouth/lips are numb. Through the night I developed some aching in my left shoulder. No treatment. Just an annoying feeling of not being able to feel my upper arm. It feels cold as well.
60 2021-02-27 pain in extremity That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches... Read more
That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain
60 2021-02-28 numbness Numbness sensation in lips to cheeks nose & forehead
60 2021-02-28 pain in extremity Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level ... Read more
Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.
60 2021-02-28 tenderness, pain in extremity Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm... Read more
Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm where injection was given; ice was used to reduce swelling and was alternated with heating pad. soaked in warm bath with epsom salts. relief was finally achieved by taking 1 Aleve liquid gel capsule - 220 mg. Swelling and pain began within 24 hrs after injection and pain increased intensely by hour 36. Some tenderness to touch still in lymph glands in armpit/chest and to underside of arm. minimal tenderness at actual injection site - no more than normal for a injection.
60 2021-02-28 pain in extremity When I received the vaccine, the technician administering the vaccine had a difficult time pushing i... Read more
When I received the vaccine, the technician administering the vaccine had a difficult time pushing in the syringe. He moved it around a little bit and pushed hard again. After he pulled the syringe out, he kept tapping it, I guess to make sure all of it went into my arm. When he was administering it, I had a burning sensation as it went in. No one I know had this occur during their vaccine. Due to working environment, I need to know that I received the vaccine, and that something did not go wrong and it failed. Can you let me know if I still received the vaccine after experiencing this during the administration of the vaccine? I am very nervous that it failed and I am not protected. I had a slightly sore arm the evening of the vaccine, but it was gone the next day.
60 2021-02-28 weakness flu like symptoms, head ache, weakness, body aches
60 2021-03-02 tremor Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appet... Read more
Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.
60 2021-03-03 migraine At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 1... Read more
At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 16 hours. I reported it to the nurse practitioner but did not want to see her because I knew it would resolve. I am a nurse and expected it would improve on it's own and it did. I did take Tylenol for the symptoms when they began. I work in a clinic.
60 2021-03-03 pain in extremity SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSE... Read more
SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL
60 2021-03-04 flushing, feeling hot COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient dev... Read more
COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD
60 2021-03-04 feeling cold I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was ... Read more
I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.
60 2021-03-04 weakness Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature ... Read more
Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9 The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.
60 2021-03-04 pain in extremity Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on m... Read more
Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.
60 2021-03-04 difficulty speaking Scatchy throat, affected voice, swollen tongue
60 2021-03-04 numbness Within 15 minutes right facial numbness and eyelid swelling, mild lid droop, lasted 4 hours
60 2021-03-07 weakness, pain in extremity Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme... Read more
Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
60 2021-03-15 tingling my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow wate... Read more
my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.
60 2021-03-17 pain in extremity Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness ... Read more
Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-03-17 weakness Temperature 103 degrees and weakness
60 2021-03-17 unresponsive to stimuli This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was s... Read more
This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am
60 2021-03-21 tingling Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the muc... Read more
Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; Tingling; prickly sensation on tongue when eating; cold items felt opposite of what they should, more like burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 12:45 as single dose for COVID-19 immunization. Medical history included known allergies to Sulph. The patient was not pregnant. Concomitant medications included aceclofenac (BIOFLEX [ACECLOFENAC]), calcium (CITRICAL [CALCIUM]) and vitamin D (VITAMIN D [VITAMIN D NOS]). On 01Mar2021 08:00, the patient experienced sialadenitis (salivary gland inflammation), glossitis (tounge inflammation), inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips. Tingling, prickly sensation on tongue when eating, cold items felt opposite of what they should, more like burning sensation were also reported. Onset of symptoms Monday morning, symptoms peaked Wednesday evening through midday Thursday, greatly improved by Friday morning. The patient had a COVID test on Friday to be sure and it was negative. There were no treatment for events. No COVID prior vaccination. The patient had a COVID test type post vaccination-Nasal Swab (Covid 2 PCR) on 05Mar2021 which was negative. The patient had The outcome of the events was recovered on unspecified date in Mar2021.
60 2021-03-25 weakness things went black; my blood pressure was alarmed was over 200 checked other arm same called there te... Read more
things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-03-29 flushing Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from ... Read more
Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EN5318) via an unspecified route of administration in left arm on 09Mar2021 at 10:00 AM (at the age of 60-years-old) at single dose for COVID -19 immunisation. Medical history included systemic lupus, asthma, rheumatoid arthritis, thyroid cancer. She had allergies for antibiotics, pneumovax and morphine. She had taken other medications in two weeks. No other vaccine in four weeks was received. She experienced urticaria, bronchospasms, itchiness, shortness of breath, flushing/redness on 09Mar2021 at 10:15 AM. The adverse event was resulted in emergency room/department or urgent care. She was treated with IV fluids, benadryl, decadron and solumedrol. She did not have COVID prior vaccination and COVID tested post vaccination. Outcome of events was ecovering. No follow-up attempts are possible. No further information was expected.
60 2021-03-31 numbness 3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of fac... Read more
3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of face, nausea and vomit once. Went to ER around 12:30am on 3/30/21. Admitted to the Hospital from 3/30/21-3/31/21.
60 2021-04-01 bell's palsy she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a cont... Read more
she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 17:30 (at the age of 60years) as single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient is not pregnant at the time of vaccination. Concomitant medications included colecalciferol (VITA D); ascorbic acid (VITAMIN C); fish oil; ubidecarenone (COQ10); magnesium; and zinc; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph nodes swelled on the same side where she received the shot. Also, the left side of her checks down to neck and shoulders felt weird, she can't quite explain the feeling; she thought she was getting Bell's Palsy which is one of the adverse reactions. She was alarmed as she was unaware of the swelling of the lymph nodes. The adverse events occurred on 19Mar2021 (16:30). There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.
60 2021-04-03 muscle spasms 12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post... Read more
12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.
60 2021-04-05 pain in extremity, tremor, burning sensation Allergic reaction . Tremors. Ataxia. Spent 36 hours in ER with violent tremors, the tremors lasted... Read more
Allergic reaction . Tremors. Ataxia. Spent 36 hours in ER with violent tremors, the tremors lasted 4 days follow by burning and painfully legs especially, in calf area made walking painful. As of this report legs still painful.
60 2021-04-06 difficulty speaking My throat was itchy in between that half hour my voice started to change; my throat felt worse; I ha... Read more
My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
60 2021-04-06 pain in extremity On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then th... Read more
On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then there was a rash all around my thigh. The pain is still present and the rash has gotten worse. I went to my doctor on 4/6/21 and he says the event is caused by the vaccine. He said the symptoms resemble shingles but also varies from shingles.
60 2021-04-07 weakness shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital ... Read more
shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital and discharged on 4/2
60 2021-04-09 hot flush Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along... Read more
Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along her heart, collar bone area, and ribs; Hot flash on the left side of her head preceded the headache; Headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included sickle cell anaemia diagnosed when she was a baby from an unknown date unknown if ongoing. The patients concomitant medication included unknown injectable medication the patient stated she was given injectable medication for 2 tests, 1 on 23Feb2021 and 1 on 26Feb2021. She said she didn't know the name of the medications given to her and the tests were ordered by her cardiologist. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient experienced sickle cell crisis on 18Mar2021 headache on Mar2021, she said she was unable to touch her collar bone because of the pain on an unspecified date, pain along her heart, collar bone area, and ribs on an unspecified date, hot flash on the left side of her head preceded the headache on an unspecified date. The patient was hospitalized for sickle cell crisis from 19Mar2021 to 20Mar2021. The patient was still had sickle cell crisis pain along her heart, collar bone area, and ribs. She said she was unable to touch her collar bone because of the pain. She said she also had a headache. She clarified the headache started a couple days after she had the COVID-19 Vaccine. She said a hot flash on the left side of her head preceded the headache. She said she still had a headache, and some days her headache was better. She said yesterday (24Mar2021) her headache was so strong. She said the headache was on the left and back side of her head, but particularly strong on the back side of her head. The patient went to the Emergency Room after midnight on 19Mar2021. She said she spent the night at the hospital as an inpatient, and then was discharged by Saturday (20Mar2021) afternoon, around 14:30-15:00. She said she was given Morphine for pain, and was on an IV, and took her regular medicines. She said she did not know the name of the IV fluids that were given to her. The patient underwent lab tests and procedures which included cardiac stress test and electroencephalogram result was unknown. The outcome of event hot flash on the left side of her head preceded the headache was unknown and outcome of all other events was not recovered, Information on the lot/batch number already available. Further information has been requested.
60 2021-04-09 burning sensation, tremor, pain in extremity vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urin... Read more
vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.
60 2021-04-12 numbness, slurring Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional... Read more
Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient said she experienced left side numbness, slurred speech, severe neck pain, and a headache. She said she had stroke like symptoms but after being hospitalized for 3 days and having a CT scan performed stroke was ruled out.
60 2021-04-17 bell's palsy Bells Palsy right side of face; This is a spontaneous report from a contactable consumer (patient). ... Read more
Bells Palsy right side of face; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient (patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number En6208), via an unknown route on 15Mar2021 at 12:00 pm (at the age of 60-years-old) at single dose on the left arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Relevant concomitant medications patient received within 2 weeks of vaccination included pantoprazole 40mg. On 15Mar2021 at 12:00, the patient had Bells Palsy right side of face. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the event. Outcome of the event Bells Palsy right side of face was recovered in 2021. Follow up attempts are needed. Information on the lot/batch number has been requested.
60 2021-04-18 pain in extremity, burning sensation appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; enti... Read more
appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.
60 2021-04-20 cold sweat I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all co... Read more
I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.
60 2021-04-20 tingling, numbness her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little ... Read more
her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.
60 2021-04-21 breast pain 1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of... Read more
1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs. 2) Sharp breast pain, on the left breast,
60 2021-04-24 bell's palsy, feeling cold Bell's Palsy; right side of mouth felt numb; freezing cold; This is a spontaneous report from a cont... Read more
Bell's Palsy; right side of mouth felt numb; freezing cold; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in right arm on 01Apr2021 15:15 (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included high blood pressure. The patient had known allergies with Allegra. Concomitant medications included pravastatin; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); and bupropion. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), administered in the left arm on 14Mar2021 at 04:00 PM for COVID-19 immunisation. On 02Apr2021 at 13:00, the patient got freezing cold. The patient was cold for several hours. On 03Apr2021, the patient woke up and right side of mouth felt numb. The patient went to urgent care and was diagnosed with Bell's Palsy on 03Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy, freezing cold, and right side of mouth felt numb. The patient had not yet recovered from the events.
60 2021-04-24 tremor possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like... Read more
possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.
60 2021-04-26 feeling hot, pain in extremity This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old fem... Read more
This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
60 2021-04-26 numbness, slurring her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional ... Read more
her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.
60 2021-04-27 weakness She had a slow infection in her chest; She was breathing fine, but she got out of breath every now a... Read more
She had a slow infection in her chest; She was breathing fine, but she got out of breath every now and then; her immune system was not too good; no sleeping; She was so tired; she woke up on Thursday (08Apr2021) sick; She had a cold all year long, but normally doesn't have a color from her chest and nose (mucus). She said she now had a color to her chest and nose mucus; Has had a bad cold after the vaccine and an infection in her lungs; She had no energy, and couldn't work; This is a spontaneous report from a contactable consumer, the patient. This 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration in the left arm on 07Apr2021 around 12:15 (at the age of 60 years-old) for COVID-19 vaccination. Medical history included smoker since 1976 pack-a-day of cigarettes since 16, quit for 11 months, she went back to smoking, x-rays done in the 1990's and the patient was told that the lower part of her lungs were flat and was told she had chronic obstructive pulmonary disease (COPD) and emphysema at that time. She said her lungs were pretty bad. Family Medical History Relevant to adverse events were not provided. Concomitant medications included ascorbic acid, rosa canna fruit (VITAMIN C PLUS NATURAL ROSE HIPS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had a slow infection in her chest on an unspecified date (also reported as her doctor told her she had a little bit of an infection), a bad cold after the vaccine and an infection in her lungs on Apr2021, she woke up on Thursday 08Apr2021 sick, was so tired on 08Apr2021, had no energy and slept for 5 hours, couldn't work on Apr2021, had a cold all year long, but normally clear drainage from her chest and nose, she now had a color to her chest and nose mucus on Apr2021, she was breathing fine, but she got out of breath every now and then on an unspecified date and her immune system was not too good on an unspecified date. She reported that on 11Apr2021 to 13Ap2021 she has been fine, no sleeping. The patient had been told by her doctors that her immune system was not too good, and she should quit smoking. She said her sister was a licensed practical nurse (LPN), and her sister told her that she thought she (the reporter) may have had a cold when she got her first COVID-19 Vaccine. She said she had felt good since Sunday (12Apr2021). She said she felt stronger, but her cold was not better. She said she was breathing fine, but she got out of breath every now and then. The patient reported that she would get a lung infection if she had a bad cold. She said her doctor told her she took way too many antibiotics in the past, and now her body was used to the antibiotics It was also reported that she said she doesn't take antibiotics. She reported that her second COVID-19 Vaccine dose was scheduled for 05May2021, which was 4 weeks after the first COVID-19 Vaccine dose. There were no relevant laboratory tests done. There were no emergency room (ER) or physician office visits. Nature Made Vitamin C 1000mg yesterday (12Apr2021). She said she was taking 1 Nature Made Vitamin C (Lot Number: 2370401, Expiration Date: Feb2024) 1000mg a day. Adverse events following prior vaccinations were not applicable. The clinical outcome of no sleep, chest infection, no energy, couldn't work, out of breath, immune system was not too good was unknown, not recovered for cold, sick, color to her chest and nose mucus and recovering for tired. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
60 2021-04-27 muscle spasms thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is e... Read more
thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure high diagnosed about 7-8 years ago. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid vaccine on 09Apr2021. On Saturday, 10Apr2021, she got this severe cramp in her left leg below the knee to her toes and it is extremely painful and thought she was having stroke. She stated that she was treating with a warm cloth and was going to go to the emergency room; rubbing down in case there is a blood clot. She wanted to know if this could be from the vaccine. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
61 2020-12-31 muscle spasms Body ache, head ache, fever, nausea, liwer leg muscle spams/cramping
61 2021-01-03 speech disorder, burning sensation, cold extremities About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, ... Read more
About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation
61 2021-01-03 weakness Extreme fatigue, weakness, lightheaded, malaise
61 2021-01-03 tingling, numbness Lips and left side of face numbness and tingling about 10 minutes after first dose of Pfizer COVID-1... Read more
Lips and left side of face numbness and tingling about 10 minutes after first dose of Pfizer COVID-19 vaccination. Started first on the lips and then spread to left side of face and continued for 45 minutes to an hour after vaccination.
61 2021-01-04 feeling of body temperature change Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills... Read more
Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
61 2021-01-04 muscle twitching Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseat... Read more
Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.
61 2021-01-04 hot flush, discomfort aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was fr... Read more
aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.
61 2021-01-04 feeling hot development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all ove... Read more
development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all over body--temp 96.8 temporal but felt very, very warm took Benadryl rash faded, decreased itchiness
61 2021-01-05 numbness I went to the emergency room which after the Pfizer injection I had numbness sensation to my face a... Read more
I went to the emergency room which after the Pfizer injection I had numbness sensation to my face and upper lips, nose and mouth. I feel a pulling sensation to her lips and nose. I have brain fog. I feel the injection affected a nerve in my face. She went to see her primary doctor put her on anti-histamine medication. She states she has no itching at the moment.
61 2021-01-05 pain in extremity Sore arm starting about 2 days after vaccination lasting for 48 hours.
61 2021-01-06 pain in extremity Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; Th... Read more
Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on left arm at single dose for COVID-19 immunization on 23Dec2020 at 61-year-old. No medical history or concomitant medication. Yesterday (30Dec2020), the patient woke up with a sore throat, it was like getting cold with a sore throat, congested, the patient had cold like symptoms, seemed like the patient was getting a cold. The patient just took decongestant medication. After waking up this morning (31Dec2020) the patient did not have taken anything. The patient got tested for COVID (for antigen not a PCR) yesterday (30Dec2020) and was negative. The patient did not have got any fever, just sore arm a week ago (Dec2020). She was hurting for a day and then she was good, everything good. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.
61 2021-01-06 weakness Fever 101.7 Chills, Body Aches, Generalized Weakness, Head Ache, Diarrhea
61 2021-01-06 cold extremities, tremor, speech disorder, weakness, burning sensation Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside t... Read more
Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-01-06 numbness, cold extremities left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the s... Read more
left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe
61 2021-01-07 discomfort 1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after... Read more
1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM
61 2021-01-07 flushing Chills. Nausea. Headache. Body aches. Flushed face
61 2021-01-07 weakness Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had ... Read more
Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.
61 2021-01-07 tremor Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one ho... Read more
Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.
61 2021-01-07 pain in extremity fever 101, arm soreness, body aches, fatigue, nausea, congestion and dry cough
61 2021-01-07 numbness, pain in extremity pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a ... Read more
pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 12:12 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included SVT this was recognized at least 20 years ago, around the age of 30, she started to deal with high blood pressure, allergic to penicillin. The patient's concomitant medications were not reported. The patient previously took codeine, levothyroxine: allergic to codeine, levothyroxine. The patient also previously took Tylenol with Codeine and that was horrible and she can't ever take it again, when she was around the age of 40 years old. The patient received the COVID vaccination around Wednesday 30Dec2020 at 12:12 p.m. She was perfectly fine until late Thursday afternoon 31Dec2020, around 3:30-4:00 pm. She started to have swollen lymph nodes. It was only a little bad at first and then she started getting more and more swelling. She spoke with her facility's RN who suggested she use some cold and warm packs/compresses and also take some Tylenol to deal with it. She has had the swelling for this many days now. It's not bad swelling but she her lymph nodes are still so swollen. She thought it was a regular reaction, but now it's been too long. Her lymph nodes are not swollen humongous. There is no redness. Her lymph nodes are not hard, just swollen. The swelling was a little bit better on Friday and Saturday but yesterday, it started bothering her again. She has had pain in her whole arm on an unspecified date. On 03Jan2020, her face also started to feel funny. She clarifies by "feeling funny", she meant she started to experience numbness in her right cheek, only her cheek, like when one gets a vaccination when they go to a doctor's office/dentist office and it starts working and one can feel it getting numb. She also experienced numbness in her arm. She clarifies when she puts pressure on her arm (like putting her arm on the desk), she feels numb in her hand. She verifies the numbness in both her cheek and arm started occurring on 03Jan2020 around 7-8pm. She is fine today and then she'll start to feel the numbness again in her cheek and arm. She clarifies the numbness comes and goes. It comes in the morning and then goes away and then the numbness starts again. She started to feel numb in her face and cheek, like when one gets a Novocain at the dentist office and it starts working- it's like the same feeling. The outcome of the events Swollen lymph nodes and numbness in right cheek/numbness in arm/hand was not recovered, while unknown for the other event. Information on the lot/Batch number has been requested.
61 2021-01-08 feeling hot About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left d... Read more
About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.
61 2021-01-08 burning sensation, flushing First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next da... Read more
First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.
61 2021-01-08 pain in extremity Low grade fever, fatigue, body aches, arm pain
61 2021-01-08 breast pain muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blis... Read more
muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blistering; redness on left should blade and over left breast
61 2021-01-09 numbness Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambul... Read more
Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambulance called, tested to rule out stroke and blood sugar issue but tested ok. Determined I had allergic reaction to vaccine.
61 2021-01-09 pain in extremity chills, fever, arm pain
61 2021-01-10 pain in extremity 24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 h... Read more
24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair
61 2021-01-10 numbness I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a... Read more
I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a few days after.
61 2021-01-10 pain in extremity Low grade fever body aches chills headache arm soreness
61 2021-01-10 pain in extremity Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to... Read more
Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to touch.
61 2021-01-10 pain in extremity SORE ARM,HEADACHE LOWER BACK PAIN FATIGUE
61 2021-01-11 pain in extremity Arm pain post injection Severe pain in shoulder joint, down arm, pain elbow, pain firearm and hand o... Read more
Arm pain post injection Severe pain in shoulder joint, down arm, pain elbow, pain firearm and hand on left side. Diagnosed as reactive arthritis due to vaccine
61 2021-01-11 weakness Fever/chills 104.8, N/V, severe fatigue/weakness, severe headache, body aches
61 2021-01-11 feeling hot Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hour... Read more
Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.
61 2021-01-11 pain in extremity myalgias, chills, left arm soreness, vertigo
61 2021-01-12 weakness Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills ... Read more
Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills and extreme fatigue lasted 4 hours. Low grade fever lasted 12 hours.
61 2021-01-12 flushing Flushing of neck and cheeks.
61 2021-01-12 muscle spasms Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and mo... Read more
Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!
61 2021-01-12 tingling, numbness On my drive back to work after getting the vaccine the left lower part of my face when numb and ting... Read more
On my drive back to work after getting the vaccine the left lower part of my face when numb and tingly. Then it focused on my left nostril. The overall effect didn't last long but my nostril still doesn't feel right. Somewhat numb but not always. The left side of my face feels strange at times as well. Hard to explain.
61 2021-01-12 speech disorder, discomfort, tingling Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias o... Read more
Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.
61 2021-01-12 pain in extremity, tremor Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant bod... Read more
Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant body aches & pain. The next day, 1-13-21, Temp 100.4, continued body aches, very tired & sleepy. Sore right arm, body aches from head to toe. Taking Motrin again.
61 2021-01-13 pain in extremity, hot flush About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I ... Read more
About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I also started feeling lightheaded like I might faint. I pull over into a parking lot and had a family member come get me to drive me home. I was extremely thirsty and drank a lot of water at home. Eventually, my redness went away and my face did not feel as hot. I did feel other more typical symptoms too such as painful arm, and flu like symptoms. I am mainly concerned about the reaction I had when driving home since it was similar to what happens when I take cortisone or Doxycycline. I am needing information as to whether it is safe for me to take my second dose of the covid vaccine.
61 2021-01-13 hot flush At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed a... Read more
At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.
61 2021-01-13 weakness Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at mid... Read more
Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today
61 2021-01-13 tremor Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determi... Read more
Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ
61 2021-01-14 weakness Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating... Read more
Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating. Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020. The outcome of events was recovered on 08Jan2021.
61 2021-01-14 pain in extremity DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/... Read more
DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/10/21.
61 2021-01-14 feeling cold, tenderness Feeling cold, headache, chills, tender arm, fever
61 2021-01-14 flushing Patient instructed to wait 30 min post vaccine administration. After 30 min patient reported feeling... Read more
Patient instructed to wait 30 min post vaccine administration. After 30 min patient reported feeling flush and cheeks were slightly red. O2 sats 98%, HR 62 bpm, denies shortness of breath. Notified Dr. who gave a telephone order for Benadryl 25mg PO now. Instructed patient to stay 30 additional for observation post Benadryl administration.
61 2021-01-14 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at inje... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.
61 2021-01-14 breast pain, tenderness, pain in extremity Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, ... Read more
Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10
61 2021-01-14 pain in extremity but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then... Read more
but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown. Information on the lot/batch number has been requested.
61 2021-01-15 tingling immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by ... Read more
immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by unusual feeling in mouth, not itchy, but tingly-type sensation. lasted about 1 1/2 hours, same reaction happened with both first and second doses, the second time was a little more intense and longer lasting.
61 2021-01-17 numbness 2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout mu... Read more
2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout muscles, tongue felt thick, mild tongue coordination alteration. Left 2nd and 3rd branch trigeminal nerve mild numb sensation though unclear if I have mild paresis too. Mildly reduced tongue coordination continues.
61 2021-01-17 pain in extremity Hands are hurting, looks like I have some bleeding under the skin on my left hand, middle finger, ha... Read more
Hands are hurting, looks like I have some bleeding under the skin on my left hand, middle finger, hands are swollen and have a spotted look on the underside. Tried taking over counter meds, nothing is helping with pain.
61 2021-01-17 tingling, feeling cold, tremor Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left... Read more
Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.
61 2021-01-18 pain in extremity DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 TH... Read more
DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 THRU 01/19 SORE ARM 01/09 THRU 01/19
61 2021-01-18 pain in extremity Severe Left Leg Pain, thing started about three hours after the shot and it so severe screaming an... Read more
Severe Left Leg Pain, thing started about three hours after the shot and it so severe screaming and needed pain medicine . The next morning left work due to pain . 12/28/2020. Physical Exam and called it sciatica but not what it was It was inflammation of left fascia lata the Tramadol 50mg and Percocet 5 mg and Prednisone 5 days and it was better by 90% after receiving second shot worsened for a day then back 90%
61 2021-01-18 pain in extremity Though I had pain and soreness in the arm after both the shots I am left with a residual weakness an... Read more
Though I had pain and soreness in the arm after both the shots I am left with a residual weakness and ache in the arm almost a month later. I find I am not able to lift items that I was able to lift last month and there is a lump in my left upper arm that is new as well.
61 2021-01-18 tremor chills shakes nausea vomiting cough sob sore throat maliase
61 2021-01-18 burning sensation she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had... Read more
she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.
61 2021-01-19 difficulty speaking After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to dev... Read more
After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to develop difficulty swallowing by the time I reached my car. Waited a few minutes and it did not abate and continued worsen,. Went to hospital's ER and was seen by Dr. At that time, my voice had become coarse and gravely. Was given oral steroid and a Benadryl. Symptoms lessened a bit and were gone after about 2 hours. While at first I thought my breathing wasn't affected, after symptoms cleared, I realized that my breathing was easier. Symptoms did not reoccur.
61 2021-01-19 flushing, tingling Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and ... Read more
Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.
61 2021-01-19 flushing, tingling Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccinat... Read more
Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccination. At 1208 on 1/20/2021 pt received 2nd dose of COVID Pfizer vaccine. Immediately after vaccination, pt experienced unusual taste in mouth, flushing, and feeling of heat in chest. At 1232, pt noticed flushing on arms and feelings of heat and pins and needles in both arms, hands, chest, both feet, and back. Sensation was persistent, so at 1301, 50 mg of IM Benadryl administered to RD by NP. By 1320 flushing on arms and chest subsided, feeling of pins and needles persisted but was not as severe as initial reaction. By 1345 flushing on arms returned, pins and needles sensation worsened again in all locations noted prior, spread to scalp, and tingling sensation occurred on lips. Pt communicated with Dr advised to stay under observation, but transfer to ED not medically necessary. At 1415, pt was advised to go home with supervision of partner and monitor symptoms from there.
61 2021-01-19 feeling hot, tingling, feeling cold I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a wa... Read more
I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.
61 2021-01-19 pain in extremity Larm pain, low grade temp to 100.2, mild headache
61 2021-01-19 breast pain Painful lymph node in the arm where she had the vaccination and radiates to her breast
61 2021-01-19 muscle spasms, muscle twitching Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours... Read more
Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.
61 2021-01-19 tingling Tingling in left face check..legs very weak .. congestion..very tired for 4 days
61 2021-01-20 feeling hot Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6... Read more
Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6 to touch and on abduction. About 11 hours after vaccination, I became increasingly uncomfortable, feeling warm, chills, muscle aches. I could not sleep. 22 hours after vaccination, my temperature was 101 F (did not take it before this time). Temperature waxed on waned from that point (day #2). About 36 hours after the vaccine, my temperature stabilized to normal. 48 hours after the vaccine, I felt better and better with each hour.
61 2021-01-20 feeling cold Day after 2nd vaccine, developed chills, fever of 99.4, and overall body aches
61 2021-01-20 weakness, feeling hot Felt very weak and very hot. No fever.
61 2021-01-20 pain in extremity Global myalgia, chills, high fever, significant arm pain. Excedrin used. Symptoms mostly resolved.
61 2021-01-20 discomfort felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fati... Read more
felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."
61 2021-01-21 weakness, tremor I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs fe... Read more
I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.
61 2021-01-21 migraine STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine.... Read more
STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)
61 2021-01-21 pain in extremity Sore arm
61 2021-01-23 tingling Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs... Read more
Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs.
61 2021-01-24 tingling Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left... Read more
Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left eye felt "weird." Took Advil, got better after no difference with Tylenol. Then stopped the Advil and symptoms persisted. Then had tingling of head and neck. Saw her physician and Carotid flow study was normal. Waiting for MRI approval. Has been working with the symptoms.
61 2021-01-24 facial paralysis Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfor... Read more
Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
61 2021-01-25 numbness, tremor Patient seated in observation area for a 30 minute observation after injection of Covid 19 vaccine. ... Read more
Patient seated in observation area for a 30 minute observation after injection of Covid 19 vaccine. Patient after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was A&O x4, lungs clear to auscultation, patient stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on RA and B/p of 130/80. at 1016 covering provider ordered to give patient given 12.5mg of Benadryl liquid with 16oz of Water intake during observation period. Continued to monitor patient and noted that was able to ambulate at 1025 to bathroom with assistance but still experiencing dizziness. Patient monitored for a total of 45 minutes then discharged home.
61 2021-01-25 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 1... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 11 pm to use the restroom and when I returned to bed I had a cough and SOB. This continued with copious secretions with worsening over time until I was fighting for air at 4:30 am. My husband called the ambulance because he did not feel he could get me to the hospital in time. In the ambulance I was started on 4L of O2. Upon arrival at the ER I was given a breathing treatment and started on the BiPap. I was admitted to the hospital and received 3 more breathing treatments and recovered to be on room air by 11:00 pm. The tests and observations, the doctor reported that there was no other cause than the vaccine.
61 2021-01-26 flushing After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was ... Read more
After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was thinking it may have been just some anxiety. I left the center after 15 minutes and came back to Pediatric office where I work. I did take a Zyrtec and felt completely better after approx. an hour. After the 2nd dose I did mention I had felt odd after 1st dose and decided to sit for 30 min. I felt about the same as I did after the 1st dose so I left. when I got to my car my face was flushed. I was not tachycardia just a very odd felling in my head and then my tongue did start to itch (or feel funny) . I took a Zyrtec and went home. I never had any swelling of lips or tongue, no trouble breathing. Pulse stayed constant around 80. This time the symptoms lasted approx. 4 hours. I I did continue to take Zyrtec for 3 days after injection.
61 2021-01-26 pain in extremity, weakness, hot flush, cold sweat Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, sl... Read more
Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.
61 2021-01-26 feeling cold Monday afternoon, January 25, I started feeling achy and chilly. Just not well. I work 5 a.m. to 1... Read more
Monday afternoon, January 25, I started feeling achy and chilly. Just not well. I work 5 a.m. to 1:30 p.m. I went straight home from work. I took shoes off and got in bed. I was very cold and felt that the coldness was from inside out especially in my hands. I covered with a sheet and 3 blankets with an extra blanket to my feet and used winter gloves on my hands. I got up at 5 p.m and felt better. Tuesday morning, January 26 at 3 a.m. when I got up to shower, I noticed a soreness and large swelling under left armpit, ? lymphadenopathy. All others symptoms had passed. Continues to be the same on today, January 27. Seeing MD on Thursday, January 28.
61 2021-01-26 feeling cold felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; Th... Read more
felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; This is a spontaneous report from a contactable consumer report self. This 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL4176), via an unspecified route of administration at left arm on 12Jan2021 14:30 at single dose for covid-19 immunization. Medical history included COVID in Nov2020 (Patient was tested for Covid on 23Nov2020 and found out the 25Nov2020 the result was positive), she just quarantined herself at a hotel (They gave her Benzonatate, but she was also taking Tylenol 500mg and Robitussin DM). Concomitant medications not reported. Patient did not get any other shots or 4 weeks prior. No problems with vaccines in past that she can remember. No additional vaccines administered on same date of the Pfizer suspect. Patient received the Pfizer BioNtech vaccine on 12Jan2021 and after that on 12Jan2021 night she didn't feel anything but mild pain in arm, it was so painful, but not as bad on 13Jan2021 even though she still has it. She can't move her arm up and down. On 13Jan2021 morning at dawn she had a fever and it is now 101.2. Has taken Tylenol 500mg (Lot number: SLA071, UPC number: 30047112, Expiry Date: Aug2024). Patient had body aches started 12Jan2021 at midnight (12:00) that is start date of 13Jan2021. She felt cold and chilly and not sure if it was the weather or her. No Emergency Room or Physician Office visit. The outcome of "felt cold and chilly" was unknown, of else events was not recovered.
61 2021-01-26 tremor headache, shakiness, chills, lightheadedness
61 2021-01-26 facial paralysis, one side paralysis hemiparesis left, facial droop, weakness on left upper and lower extremity
61 2021-01-26 pain in extremity unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffnes... Read more
unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-01-27 feeling cold A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headac... Read more
A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.
61 2021-01-27 unresponsive to stimuli Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been r... Read more
Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.
61 2021-01-27 pain in extremity Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contact... Read more
Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.
61 2021-01-27 numbness about 30-45 minutes later started feeling numbness on left side of face; left lower lip remained sli... Read more
about 30-45 minutes later started feeling numbness on left side of face; left lower lip remained slightly numb; This is a spontaneous report from a contactable nurse. A 61-year-old female nurse reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1686), intramuscular at single dose into the left arm on 08Jan2021 at 03:30 PM for COVID-19 immunization. First dose of BNT162B2 was received on 18Dec2020. Medical history included rheumatoid arthritis, coronary artery disease and hypertension. Past drug history included NSAIDS which caused bleeding. The patient's concomitant medications were not reported. The patient reported that about 30-45 minutes after vaccination she started feeling numbness on left side of face and left lower lip remained slightly numb. The events were reported as non-serious. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
61 2021-01-27 feeling hot headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer ... Read more
headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.
61 2021-01-27 feeling hot tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe naus... Read more
tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.
61 2021-01-28 weakness Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol ... Read more
Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol for relief. still feeling weak. can't stand up long without feeling dizzy.
61 2021-01-28 pain in extremity day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around... Read more
day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around the shot area.
61 2021-01-29 bell's palsy Bells Palsy Signs and Symptoms Right Side for the last 72 hours with ear pain and eye twitches. n... Read more
Bells Palsy Signs and Symptoms Right Side for the last 72 hours with ear pain and eye twitches. noticeable onset this morning 1/30 with right eye right and upper lip involvement.
61 2021-01-29 numbness alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves ... Read more
alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.
61 2021-01-29 flushing in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt... Read more
in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt warm. extreme tinnitus. took Benadryl and slept. after 5 hours, symptoms came back. feels like lower jaw is pulling to right. took more benadryl.
61 2021-01-31 pain in extremity Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness... Read more
Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.
61 2021-01-31 numbness, tingling right arm numbness and tingling
61 2021-02-01 pain in extremity Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hur... Read more
Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis. The patient medical history was not reported. There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.
61 2021-02-01 pain in extremity sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache;... Read more
sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache; arm hurts; The initial case was missing the following minimum criteria- No Adverse Effect. Upon receipt of follow-up information on 19Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided - "has not received information card "), via an unspecified route of administration on 17Jan2021 at single dose on the left arm for COVID-19 immunization (reported as "Why was the patient taking Covid-19 vaccine (Verbatim): works in a group home "). Medical history included ongoing heart murmur since 2019. There were no concomitant medications. There were no investigation assessment. The patient experienced low-grade fever, chills and a bad headache on 17Jan2021. Patient was sluggish and wanting to sleep all day on 18Jan2021. Patient took Tylenol for a headache. It did not work so she took sumatriptan. The patient was also sneezing on 18Jan2021. Patient reported that she sweated the fever out. She had chills at night. The headache was lingering off and on but was mild. She sneezed all day on Monday (18Jan2021). She has not sneezed yet today but she has a stuffy head on 18Jan2021. Patient clarified that she took Acetaminophen Rapid Pain Relief instead of Tylenol. She took two 500mg tablets (UPC: 3225152303, Lot: 91670159AA, Expiry: Aug2022). Patient also reported that her arm hurts on 17Jan2021. She was unable to provide the Lot number. She will receive the information card after she receives the second dose. She had a picture of the card but it was not very clear. Outcome of the events arm hurts, headache, stuffy head was recovering (also reported as ongoing), for chills, low grade fever was recovered on 18Jan2021, for sluggish and wanting to sleep all day was recovered on 19Jan2021 while for other event was unknown. Information about batch/lot number has been requested.
61 2021-02-01 weakness thrush; weak; tested positive for Covid; tested positive for Covid; This is a spontaneous report fro... Read more
thrush; weak; tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunisation. Medical history included ongoing COPD (chronic obstructive pulmonary disease) (not really diagnosed with COPD), ongoing smoker (smokes about 10 cigarettes a day; has smoked 40+ years), cough. The patient's concomitant medications were not reported. It was reported that on 31Dec2020, the patient tested positive for COVID from which she went to the doctor and was treated on 14Jan2021. The patient was given SOLU-MEDROL injection just to help her because she has mild COPD to bring up all of the junk. She is clear now. She doesn't have pneumonia. Her labs were good. She feels 80% back. The patient also experienced weak and thrush on unspecified date. Therapeutic measures were taken as a result of the event tested positive for COVID which included antibiotic and a cortisone injection, and for the event thrush which included NYSTATIN mouth rinse. Outcome of the event tested positive for COVID was recovering. Outcome of the remaining events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (10 days in this case). However, a causal relationship between event "tested positive with Covid " (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.
61 2021-02-02 numbness Sudden total hearing loss, left ear; numbness in face and outer ear.
61 2021-02-03 feeling cold 12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation... Read more
12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation. Interpreter RN assisted with interpreting. Another RN assessed pt, negative wheezing &/or stridor, pt accepted bottle of water ingested/tolerated sips of water. Pt ambulated with RN w/o issue to have IM Benadryl 50 mg Right gluteus. Pt tolerated well. Pt prior hx allergies to PCN & NSAID?s w/side effects of laryngeal edema. 12:55 pm called over to pt, RN for 61 yo F with hx of laryngeal edema with PCN & NSAID?s. Pt states her throat feels scratchy, primary Spanish speaking w/interpreter at side. Assess pt no ins/exp wheezing. No stridor, no SOB on O/A 98% O2 sat, HR 67, with 90 SBP palp. Pt also, hx of anxiety. Pt given bottle of water with sips occasional clearing throat. No mouth/oral swelling visualized, however pt is requesting Benadryl. Pt does not have Benadryl on her & discussed with option of IM injection if pt feels she needs it. Pt not flushing, talking with staff & continues with no stridor. Pt again states she would like to have Benadryl. 1300 Per standing order with pt?s stated feels like her throat is having swelling/itching Benadryl 50 mg IM R gluteal with band aid applied. 1305 Per adm ALS called for f/u, pt continues with no distress, no stridor, no ins/exp wheezing. Pt sips on water & is talking with staff without distress. 1308 ALS on scene with update status, PMH & allergies with Benadryl 50 mg given @ 1300 IM, HR 67, O2 sat 98% RH, B/P 161/80 RA. Pt not in distress & is stating she feels much better, no throat swelling, just feels sleepy. Pt has husband in personal vehicle to assist pt home. Pt denies need for transport. 1323 Pt sitting in chair, calm & no distress, cont. to re-assess. 1330 Pt tolerated well & cleared for discharge to home with husband. Pt I/S to f/u with PCP if needed. Any SOB, increased anxiety d/t possible reaction, call 911 & will be re-evaluated. Pt consents to go home with husband driving.
61 2021-02-03 tingling, numbness Redness numbness and tingling in both hands Increases when hands are pointed down improves when lif... Read more
Redness numbness and tingling in both hands Increases when hands are pointed down improves when lifted above the heart Is lessening but is clearly not listed as a side effect It is improving however is concerning more information and direction needs to be addressed several other coworkers have experienced or went to the ED with the same adverse effect. It is clearly not life threatening but I hope it will not increase with the second dose or continue in the future
61 2021-02-04 pain in extremity BODY ACHES, CHILLS, JOINT PAIN, ARM SORENESS
61 2021-02-04 pain in extremity Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache a... Read more
Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache and muscle aches the next day on 1/22/21. Some fatigue and nasal congestion that next day as well. Some fatigue and headache on 1/23/21. Took Tylenol once on 1/22 and 1/23.
61 2021-02-04 facial paralysis, weakness Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, diz... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.
61 2021-02-04 feeling hot sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all da... Read more
sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all day; congestion; severe headache; severe cough; achy/was in such pain all over; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), intramuscular on 18Jan2021 12:00 at single dose (left arm) for COVID-19 immunization. Medical history included slight hypertension and allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included losartan. The patient took first dose of bnt162b2 on 28Dec2020, at 10:00 (lot EL1284) at left arm for COVID-19 immunization. When the patient went to bed that night about 10 hours after the shot, I was just achy on 18Jan2021, at 22:30. When she got up at 02:30, she was in such pain all over and had chills and was hot with a slight fever, was dizzy, and tired on 19Jan2021. When she woke up later and had to call off, she had all of that (worsening), plus congestion and severe headache on 19Jan2021. The patient slept all day, but developed a severe cough by that night and she took nighttime cold medication to sleep and when she woke up on Wednesday, she took the daytime ones. The patient reported that she still have achiness, was tired, and a sore throat and some cough on Thursday, 21Jan2021. The patient received therapy for the event severe cough; and patient did not received treatment for the rest of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovering.
61 2021-02-06 pain in extremity I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty ba... Read more
I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day
61 2021-02-06 flushing, tingling Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with... Read more
Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with heart monitor on patient. EKG WNL B./P 140/97, HR 57 o2 Sat 100 %Ambulance transported patient to Hospital.
61 2021-02-07 pain in extremity She had significant fatigue the day after the injection along with a sore arm and intermittent heada... Read more
She had significant fatigue the day after the injection along with a sore arm and intermittent headache. Starting about 72 hours after the vaccine she noticed a swollen lymph node at the base of her neck on the side of the injection. The lymph node, sore arm and intermittent headache are still present.
61 2021-02-09 muscle spasms, weakness Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneou... Read more
Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.
61 2021-02-16 pain in extremity Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101... Read more
Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have
61 2021-02-16 pain in extremity Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills, sev... Read more
Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills, severe body aches, severe headache lasting about 9 hours starting at midnight following the vaccination.
61 2021-02-16 numbness The right side of my face has gone numb as if I had a dentist's injection. Started the same evening ... Read more
The right side of my face has gone numb as if I had a dentist's injection. Started the same evening as the vaccination. Includes even the ear.
61 2021-02-16 migraine, tingling almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia a... Read more
almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia and tinnitus/ headaches/migraines; exacerbation of migraine with paresthesia and tinnitus; exacerbation of migraine with paresthesia and tinnitus/ increased tinnitus; some abdominal tightness; This is a spontaneous report from a contactable pharmacist (patient herself) via Medical Information team. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, NDC number/expiration date was unknown), via an unspecified route of administration on the left arm (also reported as upper left arm) on 13Jan2021 at 09:00 at a single dose for COVID-19 immunization; the patient was a healthcare worker and was trying to protect herself. The vaccination facility type was reported as a drive thru site. Relevant medical history included previous neurological problems, which included history of underlying migraine with paresthesia/chronic paresthesia (ongoing) and tinnitus. The patient had no family medical history relevant to the adverse events (AEs). There were no concomitant medications. The patient had no other vaccine received on the same day of the Pfizer suspect or 4 weeks prior. She never had any problems with vaccines in the past. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Initially, the patient was asking if there were any reports of paresthesia, serious neurologic adverse events, tinnitus, hearing loss, or abdominal tightness in the studies for the Pfizer-Biontech Covid-19 vaccine. After the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021, she experienced an exacerbation of migraine with paresthesia and tinnitus. She also reported experiencing some abdominal tightness on an unspecified date in Jan2021. The patient reported she was scheduled for her second dose of the Pfizer COVID-19 vaccine, but had concerns because she was still experiencing tinnitus and it was "almost like she also had some mild hearing loss" on an unspecified date. The patient further reported that she was due for the next dose the following day at the time of the report (03Feb2021). She had previous neurological problems and did not know if this did exacerbate things or not. She had migraines, tinnitus, and paresthesia and was wondering how many other patients with neurological problems reported this and was this a common side effect or adverse event reported. One doctor told her not to get the second dose and another one told her to get it and she wanted to know what she should do. The patient had headaches/migraines on the evening of vaccination on 13Jan2021 that were fairly mild and 3 days after that on 16Jan2021, they got bad and was accompanied with nausea with increased tinnitus. The migraines and nausea had gone, and the chronic paresthesia was the same as she always had, but the tinnitus was a lot louder and worse. The patient also mentioned that her migraines usually go away, but this one had lingered. The AEs did not require any visit to an emergency room or a physician office. There were no investigation assessment. The patient recovered from the event "nausea" on an unspecified date, she was recovering from the event "exacerbation of migraine/ headaches/migraines," she was not recovered from the events "exacerbation of paresthesia and tinnitus/increased tinnitus, while the outcome of the events "almost like she also had some mild hearing loss and some abdominal tightness" was unknown. The reporter assessed the events "migraine, tinnitus, paresthesia, and nausea" as serious, other medically important conditions. The relatedness of drug to the reactions/events "migraine, tinnitus, paresthesia, and nausea" was unknown as per the reporting pharmacist (Method of assessment: Global Introspection).; Sender's Comments: The 61-year-old female had relevant medical history included previous neurological problems. The reported neurological events and partial hearing loss were more likely due to pre-existing conditions, and less likely related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Event nausea was likely due to the first dose of bnt162b2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
61 2021-02-17 tremor, numbness This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time... Read more
This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time of vaccination) 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EN5318), intramuscular, first dose on 23Jan2021 09:45 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seated in observation area for a 30 minute observation after injection of COVID-19 vaccine on 23Jan2021 09:45. At 10:00, after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was alert and oriented (A&O) x4, lungs clear to auscultation. Patient also stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on room air (RA) and blood pressure (B/p) of 130/80. At 10:16, physician ordered to give patient 12.5mg of diphenhydramine (BENADRYL) liquid oral 1 dose with 16oz of water intake during observation period. Patient was continuously monitored and noted that was able to ambulate at 10:25 to bathroom with assistance but still experiencing dizziness. Patient was monitored for a total of 45 minutes then discharged home. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 23Jan2021 10:30. Case was reported as non-serious.
61 2021-02-18 tingling, numbness Patient got up from being in bed in the AM and noticed some numbness/tingling in bilateral extremiti... Read more
Patient got up from being in bed in the AM and noticed some numbness/tingling in bilateral extremities. There was concern for stroke so the patient came to the ER .The patient had received the second dose of the Pfizer vaccination 2 days prior. The patient received tPA and was treated in the ICU. After a short hospital course, the patient was discharged home.
61 2021-02-21 difficulty speaking Pt with marked hoarseness, SOB, & Wheezing. O2 sat 89%, O2 applied. Benadryl 25mg given PO, Solumedr... Read more
Pt with marked hoarseness, SOB, & Wheezing. O2 sat 89%, O2 applied. Benadryl 25mg given PO, Solumedrol 125mg given IM, Epi pen administered x2 doses. Transported via ambulance to hospital.
61 2021-02-21 pain in extremity Sharp arm pain down arm of shot. Within 20 minutes of shot experienced moderately severe vertigo and... Read more
Sharp arm pain down arm of shot. Within 20 minutes of shot experienced moderately severe vertigo and dizziness, along with difficulty breathing normally.
61 2021-02-21 weakness Vomiting, rash, dizziness, weakness
61 2021-02-21 slurring patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of va... Read more
patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.
61 2021-02-22 weakness, pain in extremity, difficulty speaking Right side upper arm ache spread to right side of neck and into headache at back and top of skull. ... Read more
Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.
61 2021-02-23 numbness 1. Facial numbness 2. Nausea 3. Pain in back of neck 4. Headache
61 2021-02-23 speech disorder Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is ... Read more
Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.
61 2021-02-24 numbness, tingling, muscle spasms Loss of use right leg. Paralysis, numbness, tingling, severe pain, and muscle spasms. Acute onset w... Read more
Loss of use right leg. Paralysis, numbness, tingling, severe pain, and muscle spasms. Acute onset without other trauma
61 2021-02-24 tingling Pain on right-side of back all the way to front of chest and under breast and part of right shoulder... Read more
Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.
61 2021-02-25 discomfort chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helpe... Read more
chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
61 2021-02-26 numbness Lips tingling, throat feels thicker, chest pressure, numbness in fingers. Evaluated by EMS-cleared
61 2021-02-27 slurring, facial paralysis, numbness In the morning of Thursday February 25 at around 6:5 AM, as I was brushing my teeth, the water was l... Read more
In the morning of Thursday February 25 at around 6:5 AM, as I was brushing my teeth, the water was leaking out when swishing from side to side. As the day progress, the right side of my mouth was getting number. The next morning Friday February 26, the right side of my face was numb, my speech was swirl, eating and drinking became challenging. I went to the emergency rom at Hospital where the team of doctors diagnosed me with Bell's Palsy. I was given Prednisone and Valtrex for a period of 7 days. Physical therapy as also being advised. The hospital advise me to follow up with my Primary Care Doctor (schedule for Monday March 1st), and to see a neurologist (waiting for an appt). As of today, the right side of my face has lost mobility.
61 2021-02-27 pain in extremity cold symptoms, headache, sore arm, fatigue
61 2021-02-28 weakness Client states that she has weakness, body aches, and dizziness since vaccine. Continues to have the... Read more
Client states that she has weakness, body aches, and dizziness since vaccine. Continues to have these symptoms
61 2021-02-28 weakness, feeling hot Rash, itchy around neck, hot, weak, drowsy, evaluated by EMS-transported to nearest ER
61 2021-02-28 pain in extremity arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips ... Read more
arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.
61 2021-03-02 pain in extremity pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the... Read more
pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the pain and her reaction lasted around 24 hours . The symptoms had subsided by 2 PM the next day.
61 2021-03-02 pain in extremity, feeling hot rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't go... Read more
rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.
61 2021-03-02 tingling shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip ... Read more
shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself. A 61-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscularly on 20Jan2021 at 14:45 (at the age of 61-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included restless leg syndrome from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (received within 2 weeks of vaccination) included tretinoin (RETIN A; skin cream), biotin, vitamin D NOS, calcium and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced shortness of breath, tingling feeling in lip and face, all on 20Jan2021, all reported as non-serious. The events did not cause hospitalization. No treatment was received for the events. The clinical outcomes of the events shortness of breath, tingling feeling in lip and face were all unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
61 2021-03-04 pain in extremity Pt s/sx started at 1200. Pt c/o stomach pain 4/10 on pain scale, throbbing pain in the L arm and nee... Read more
Pt s/sx started at 1200. Pt c/o stomach pain 4/10 on pain scale, throbbing pain in the L arm and needing to vomit. Pt denied chest pain, difficulty breathing, and difficulty swallowing. Pt denied any similar reaction to vaccines. Pt stated that she had not eaten anything that day. Pt was offered EMS. Pt refused EMS. Pt was offered an adult dose of diphenhydramine. Pt agreed to take medication. First dose administered at 1222 by RN, second dose administered by RN at 1223. Pt stated at 1250 "I feel like I need to puke." Pt was offered EMS for a second time. Pt refused EMS. Pt left vaccination site with son at 1305 with a steady gait.
61 2021-03-04 slurring Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly reso... Read more
Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later
61 2021-03-04 tingling opposite arm paresthesia
61 2021-03-06 weakness On day 2, I developed confusion and could not focus making it impossible for me to complete my work ... Read more
On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.
61 2021-03-09 pain in extremity Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consume... Read more
Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (reporter and reporter's husband). This is the first of two reports. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269 and expiry date: unknown),via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included diabetic and high blood pressure. Concomitant medication included metformin and, hydrochlorothiazide, losartan potassium (HYZAAR). Patient got the vaccine on 04Feb2021, last Thursday and the effects have not been bad, it was just arm sore on the same day. She did not have any headache but yesterday on 06Feb20021, she had a headache. No treatment was received for the events. The second dose was scheduled on 25Feb2021. Outcome of the events was recovered on Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021174383 same reporter, vaccine, different patient and event
61 2021-03-15 flushing 61 yo female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She... Read more
61 yo female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She was prescribed metoprolol and a short course of steroids by her pcp for symptomatic relief which patient took 1 dose of metoprolol and did not start steroids. She came to the ED due to her symptoms, Her main concern was why did she react to the Vaccine., and wanted answers.
61 2021-03-15 weakness Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weak... Read more
Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.
61 2021-03-15 pain in extremity nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; ... Read more
nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
61 2021-03-16 inability to speak acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who... Read more
acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who convinced his mother to come in to ED)
61 2021-03-23 tingling, burning sensation, seizure BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; ... Read more
BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.
61 2021-03-24 hot flush, pain in extremity Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh... Read more
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
61 2021-03-25 pain in extremity 3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed lat... Read more
3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed later on to shortness of breath after a week.
61 2021-03-26 inability to speak, weakness Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p... Read more
Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.
61 2021-03-29 muscle spasms pain / swollen area where injection given. joint pain in every joint in my body - never had this bef... Read more
pain / swollen area where injection given. joint pain in every joint in my body - never had this before vaccine. Facial muscel spasms; both eyes and left side of cheek area. Never had this before.
61 2021-03-30 tremor, muscle twitching, facial pain, tingling, feeling cold Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and ... Read more
Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
61 2021-03-31 facial pain, involuntary muscle movements felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quen... Read more
felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
61 2021-04-06 seizure Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs ac... Read more
Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; temp of 101.6; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 01Mar2021 17:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included end stage renal disease (ESRD), high blood pressure and pulmonary hypertension; all from an unknown date and unknown if ongoing. The patient has no COVID prior vaccination and not tested to COVID post vaccination. There was no other vaccine in four weeks. Concomitant medications (reported as Other medications in two weeks) included clonidine (CLONIDINE), macitentan (OPSUMIT), minoxidil (MINOXIDIL), carvedilol (CARVEDILOL), and tadalafil (ADCIRCA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (lot number: unknown) first dose on 22Jan2021 at 02:45 PM right arm for covid-19 immunization. The patient also previously took Hydralazine and experienced allergies. It was reported that on 01Mar2021 08:00 PM the patient went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs., acting stiff and unusual behavior. The patient's daughter took the patient and had a temp of 101.6 was sent home Tuesday morning. The events resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with sequalae (reported as with lasting effects). No treatment was given for the events. Information on the lot/batch number has been requested.
61 2021-04-07 weakness The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The... Read more
The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The next day woke up disoriented and weak. Called dr and dr recommended her call the ambulence. Went to ER and admitted to hospital. They said she had an infection and got on antibiotics. In the hospital 2-3 days and dismissed. Continue to have weakness and severe fatigue. Had 3 "MS hug"- muscles severely contract during this time- has to take muscle relaxer.
61 2021-04-09 pain in extremity, difficulty speaking feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of... Read more
feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.
61 2021-04-09 pain in extremity not sure if she has Covid; not sure if she has Covid; she got sick; queasy stomach; hurting of her a... Read more
not sure if she has Covid; not sure if she has Covid; she got sick; queasy stomach; hurting of her arm that she got the vaccine in; This is a spontaneous report received from a contactable consumer (Patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 13:00 (Batch/Lot Number: EN6206) at the age of 61-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered in parking lot. Not at Military Facility. The patient's medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included 23 years ago with her 1st flu shot she got sick but has not had any issues since. Patient stated she was scheduled for the 2nd Pfizer shot today and she got sick and was not sure if she has Covid on 23Mar2021. Stated she didn't want to get the 2nd shot and exacerbate her symptoms, states she got symptoms with her first shot. Patient was wondering if she can reschedule her shot in general as it was scheduled for today. Patient stated the symptoms after the 1st shot were not detrimental, she had a queasy stomach later that night and natural hurting of her arm that she got the vaccine in. Stated it started that night after 12 at night. Clarified she got the shot 03Mar2021 and the symptoms started after midnight making it 04Mar2021. Stated the symptoms didn't even last 24 hours and were gone by 05Mar2021. No Emergency Room and No Physician Office visit required. The outcome of the events 'hurting of her arm' and 'queasy stomach' was recovered on 05Mar2021 and the outcome of the events was unknown.
61 2021-04-10 speech disorder, slurring, pain in extremity, facial paralysis I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood press... Read more
I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before. I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
61 2021-04-10 bell's palsy, facial paralysis, numbness series of 2 covid pfizer vaccine 3/8/2021 and 3/29/2021 at pharmacy. next 24 hours achy body. Diag... Read more
series of 2 covid pfizer vaccine 3/8/2021 and 3/29/2021 at pharmacy. next 24 hours achy body. Diagnosed with bells palsy the morning of 4/2/2021. Numbness and drooping on right side of face. Unable to blink or smile. could not eat or drink. Went to local urgent care immediately and then to hospital emergency room. was checked for stroke, determined to be bells palsy. sent home with 7 day prescription of prednisone.
61 2021-04-12 muscle spasms very mild tremor in my right index finger/ finger underwent stronger and more pronounced tremors/the... Read more
very mild tremor in my right index finger/ finger underwent stronger and more pronounced tremors/the neuropathy was more pronounced; an increase in foot spasms; discomfort in my feet concurrent with an improvement in sensation in my arches; a bit more stiffness and achiness in my knees; have noticed an increase in foot spasms and discomfort in my feet concurrent with an improvement in sensation in my arches; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN), via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunization. Patient relevant medical history included diagnosed with breast cancer three years ago and have some chemo-induced peripheral neuropathy in her hands and feet. The patient's concomitant medications were not reported. Since getting her first shot on March 4, patient have noticed an increase in foot spasms and discomfort in her feet concurrent with an improvement in sensation in her arches. She also had several instances of a brief, very mild tremor in my right index finger, which was where most of the residual neuropathy in her hand resides; when the neuropathy was more pronounced, that finger underwent stronger and more pronounced tremors, whereas what patient had this month is negligible. Patient also had a bit more stiffness and achiness in her knees (both of which have recovered from traumatic injuries), which had mostly leveled off before my second shot but then regained some severity after the second, which was on March 23. (Yes, a 19-day cycle my shots were administered by Hospital. It was unknown if the patient received any treatment for the reported adverse event or not. It was unknown that patient was tested for COVID-19 after the vaccination or not. The outcome of the events was unknown. Information about on Lot/Batch number has been requested.
61 2021-04-13 pain in extremity, burning sensation, feeling hot Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills... Read more
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
61 2021-04-14 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
61 2021-04-17 weakness Extreme weakness & Fatique Dizziness Fainting Death 04/09/2021
61 2021-04-17 tremor My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super water... Read more
My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
61 2021-04-17 migraine dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache;... Read more
dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
61 2021-04-18 involuntary muscle movements, pain in extremity, muscle spasms, migraine anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely r... Read more
anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.
61 2021-04-18 numbness, speech disorder, slurring having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, lef... Read more
having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
61 2021-04-18 pain in extremity tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light a... Read more
tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
61 2021-04-20 pain in extremity, tremor severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started... Read more
severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.
61 2021-04-21 tingling, numbness After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the ... Read more
After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.
61 2021-04-23 pain in extremity Sore arm and neck on the injection side of body.; Sore arm and neck on the injection side of body.; ... Read more
Sore arm and neck on the injection side of body.; Sore arm and neck on the injection side of body.; This is a spontaneous report from a contactable Other HCP. A 61-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, in left arm on 07Feb2021 13:30 (at 61-years age) as single dose for covid-19 immunisation. Medical history included diabetes, hypertension, obesity, arthritis, copd and patient was allergic to bactrin, perfume. Concomitant medication(s) included doxepin (DOXEPIN); dapagliflozin propanediol monohydrate (FARXIGA); metformin (METFORMIN); temazepam (TEMAZEPAM); dulaglutide (TRULICITY). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.on 08Feb2021 04:00, The patient experienced sore arm and neck on the injection side of body.No treatment received for reported adverse event. The outcome of the event was resolved.
61 2021-04-24 bell's palsy Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient... Read more
Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:00 (at the age of 61years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 06Mar2021 12:00 (at the age of 61years) for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Bell's Palsy 10 days later. It was further reported that the patient had a persistent headache from date of second vaccine to now (pending clarification), including onset of Bell's Palsy. The onset date of adverse events was 07Apr2021 (11:00 AM) (as reported). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with steroids and anti-viral. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information on the lot/batch number has been requested.
61 2021-04-24 bell's palsy, pain in extremity Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating... Read more
Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating pain/shoulder pain/given high on the top of her shoulder. It hurt; sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 61-years old via an unspecified route of administration on 19Mar2021 10:10 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included systemic lupus erythematosus from 1985 and ongoing, arthritis and osteoarthritis from an unknown date and unknown if ongoing (She has osteoarthrosis throughout her body and her feet). Family history included stroke (husband died at the age of 59, he was having stroke upon stroke). The patient's concomitant medications were not reported. It was reported that when she received the shot, it was given high on the top of her shoulder and it hurt. She could not move her arm for 3 days. The pain was excruciating. On the 4th day, her arm was sore, but she could move it. She had no fevers, she didn't get sick, but she just couldn't move her arm. The shot was given at at 10:10 am, and by noon she could barely move her arm. Her left side of the mouth doesn't want to work properly. Her Bells Palsy started on 05Apr2021. She was in her car and driving to the store, when all of a sudden her left eye was watering. She got home and she didn't see anything wrong with her eye, except it was watering. She could tell a difference between the left and right side of face when she touched it. Something was wrong with her right side. Her eye was not opening all the way, it's been dropping, and her lip was down. She can't smile, and when she drinks water it's comes out. The patient clarified that it was her left side that is drooping. She went to the emergency room due to Bell's palsy. She could not move her arm within 2 hours of getting the shot. The patient mentioned her whole body aches from the Lupus and arthritis, but the shoulder pain was different after the vaccine. The shot itself hurt, and she thinks the one who administered the vaccine might have hit something. There's not a day that doesn't go by that she is not in pain. Her platelets are 200, which is very low. The patient underwent lab tests and procedures which included activated partial thromboplastin time: unknown result, blood glucose: unknown result, computerised tomogram: unknown result, full blood count: unknown result, glomerular filtration rate: unknown result; all on 06Apr2021, magnetic resonance imaging: showed a darkened area in her brain that looks like its connected with Bells Palsy on an unspecified date, basic metabolic panel: unknown result on 06Apr2021, platelet count: her platelets are 200, which is very low on an unspecified date, prothrombin time: unknown result, troponin i: unknown result (High sensitive ); both on 06Apr2021. The patient did not recover from Bell's palsy, recovered from vaccination site pain on 23Mar2021, from sore arm on 19Mar2021 and the outcome of the remaining event was unknown. Information about Lot/batch number is requested.
61 2021-04-24 tremor felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Heada... Read more
felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
61 2021-04-24 pain in extremity, numbness, muscle spasms she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hur... Read more
she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hurts a couple of days ago; Her hand is now cramped up, and she cannot bend it, almost like someone who has cerebral palsy.; she could not use her left hand; Her hand is now cramped up, and she can not bend it, almost like someone who has cerebral palsy./all her fingers are cramped and she cant open them and her hand is in a brace; radial nerve palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administration in left arm on 19Mar2021 as SINGLE DOSE for covid-19 immunization. Medical history was not reported. There were no concomitant medications. On 01Apr2021, she woke up and her left hand and arm were numb. She went to the hospital, and they told her she could have partially and had a stroke. Three days after receiving the first dose of the Covid vaccine, she could not use her left hand. Her hand was now cramped up, and she could not bend it, almost like someone who had cerebral palsy. She stated that after the first dose her left hand went numb, and she went to the hospital and was diagnosed with radial nerve palsy. She stated that all her fingers are cramped, and she can't open them, and her hand was in a brace. She stated that she would have to do physical therapy. It was her left hand, the same arm that she got the first dose of the Covid vaccine in. She could not move her left hand. She was really annoyed about it, and she was scared. The patient stated that she had a grandson and a daughter. This vaccine was the best possible way to prevent Covid. She had always got vaccines. Upon follow-up received on 09Apr2021, she was calling about the Pfizer Covid vaccine. She does not have a ride to get her second dose of the Covid vaccine on Saturday morning. She does not know the name of the facility where she was supposed to go. She was asking for help with an (cab service). She thought she was calling her county. She would call her county and ask for help with a ride. She had a reaction after her first dose of the Covid vaccine. She received the first dose on 19Mar2021. She does not know if it was because of the Covid vaccine. She was asking if she should get the second dose of the Covid vaccine in the same arm as last time. She wanted to get the second dose of the Covid vaccine in the same arm as last time, so that she does not mess up the other side of her body. She was asking what was going on with her arm. She was asking if thaws had anything to do with the Covid vaccine. Upon follow-up received on 09Apr2021, she scheduled second dose due on 10Apr. Her left arm hurts a couple of days ago, it ended her going to the hospital. She called to ask if it had something to do with the Covid vaccine. The event hypoaesthesia, cerebral palsy, muscular weakness, muscle spasms outcome was reported as not recovered. The event cerebrovascular accident, pain in extremity, radial nerve palsy outcome was reported as Unknown. The action taken in response to the events for bnt162b2 was not applicable. Therapeutic measures were taken as a result of her hand was now cramped up, and she cannot bend it, almost like someone who had cerebral palsy. (cerebral palsy). Follow-up (09Apr2021): This follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: New significant information.
61 2021-04-27 burning sensation I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pai... Read more
I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
61 2021-04-28 bell's palsy Left side of face is paralyzed,bell's palsy; This is a spontaneous report from a contactable consume... Read more
Left side of face is paralyzed,bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (61-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient is not pregnant. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. The patient experienced left side of face is paralyzed, bell's palsy (Paralysis on the Left part of the Face) on 14Apr2021 with outcome of not recovered. No treatment was given.
61 2021-04-28 pain in extremity, tingling, involuntary muscle movements passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left ... Read more
passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left pinky and ring fingers felt nerve tingling sensations; then the back of her throat had a chemical taste and tingling; then the back of her throat had a chemical taste and tingling; BP was 164/94 while lying down; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; tongue was tingling and felt swollen with an altered chemical taste for 2 days; tongue was tingling and felt swollen with an altered chemical taste for 2 days; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 (Lot Number: ER8734) at the age of 61 years old as single dose for covid-19 immunisation. Medical history included Low thyroid, kidney infections, skin rashes, high cholesterol, food sensitivities. Concomitant medications in two weeks included liothyronine sodium (CYTOMEL); levothyroxine; vitamin b complex (VITAMIN B); levoglutamide (L GLUTAMINE). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. On 12Apr2021 11:00, within 1st min of vaccine, the patient's left arm was tingling, then the back of her throat had a chemical taste and tingling, then tunnel vision, then that was the last thing she remembered until she heard her partner saying, "Are you ok?" The patient said to her she thought she fell asleep. She was an RN and said that the patient passed out for about 15 seconds and had "jerking movements" of her upper extremities before she woke up. The staff and medic helped the patient to the floor where she rested for 20 min with her legs elevated on chair. BP was 164/94 while lying down, pulse was 74. The patient returned home and continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder for most of the day. Also her left pinky and ring fingers felt nerve tingling sensations for the rest of the day. Her tongue was tingling and felt swollen with an altered chemical taste for 2 days. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
62 2020-12-31 flushing REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77... Read more
REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77. 25MG BENADRYL GIVEN.
62 2021-01-01 pain in extremity Severe left upper extremity pain and fatigue for two days after that I took two Tylenol?s and all t... Read more
Severe left upper extremity pain and fatigue for two days after that I took two Tylenol?s and all the symptoms subsided
62 2021-01-02 pain in extremity Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours l... Read more
Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite
62 2021-01-03 pain in extremity Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe ... Read more
Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.
62 2021-01-03 hot flush face feel hot and flushed within 10 minutes after injection and lasted for about 2 hours
62 2021-01-04 pain in extremity fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore ... Read more
fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore arm /arm soreness; tired; felt like she had a flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included Diabetes, allergies, heart (Heart disorder). Concomitant medications included irbesartan (AVAPRO) for heart, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies, metoprolol for heart, metformin for Diabetes, all were ongoing. The patient (Hospital scheduler/employee) had been experiencing side effects of the vaccine. She took the vaccine on 18Dec2020 and still experiencing nausea, headaches, and chills. She asked how long she would experience these side effects and if she needed to take anything. Patient reported she was exposed to someone who had COVID, her son's girlfriend had direct exposure to COVID and wanted to know how it would affect her. The patient further stated she was a hospital scheduler, she had the Pfizer Covid vaccine on 18Dec2020. She had a sore arm/arm soreness and was tired immediately after (18Dec2020), stated by Saturday 19Dec2020, she started having a low-grade fever, chills, headache, nausea, and still had the soreness in the arm. This went on for 2-3 days. Patient stated that up until now, she still had nauseous feeling that happened intermittently around early morning or mid-day, the chills were midday to early evening, it was like she didn't feel good, had to leave early from work. The fever only lasted a couple of days. She also had one isolated episode of fast heart rate that woke her up in the early hours of Sunday 20Dec2020. Caller stated she expected some of these effects to only last a couple of days but wanted to know if this was normal. She tried working 2 days last week and by mid-day she was just really tired, like she was about to get the flu, she felt like she had a flu just with no respiratory symptoms (De2020). She knew of one other coworker who was experiencing similar symptoms. No patient identifiers were provided, no further information provided. Patient did have history of allergies from when she was a child and was on medication, she was on over the counter medication Zyrtec for years, she didn't know if there could be a conflict between them. She received her vaccine part of the hospital. She also called because her son and his girlfriend live in her house and his girlfriend was exposed to someone who tested positive for Covid, she wanted to know how this may affect her since she had the vaccine. Investigation assessment was no. The outcome of the event "sore arm /arm soreness" was recovered in Dec2020, of "low grade fever" was recovered on 21Dec2020, of the events "tired", "nausea", "headache" and "chills" was not recovered, of the other events was unknown. Information about Lot/Batch number has been requested.
62 2021-01-04 pain in extremity fatigue chills arm soreness
62 2021-01-05 nerve pain, pain in extremity 1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white no... Read more
1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED
62 2021-01-05 hot flush, feeling cold Patient reports hot and cold flashes and felt that she may pass out, she went to ER and everything e... Read more
Patient reports hot and cold flashes and felt that she may pass out, she went to ER and everything else is okay
62 2021-01-05 pain in extremity swelling and joint pain in the little finger on left arm; swelling and joint pain in the little fing... Read more
swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
62 2021-01-06 weakness, muscle spasms I had the 1st Pfiser Covid Vaccine on 12/21/20 and on 12/24/20 I had abdominal pains resulting in di... Read more
I had the 1st Pfiser Covid Vaccine on 12/21/20 and on 12/24/20 I had abdominal pains resulting in diarrhea turning into bright red bleeding by the late morning on 12/25/20. I continued to bleed for hours (only when cramping) and ended up going to an ED for severe abdominal pain, bleeding, nausea and general weakness. The ED doctor said it was from internal hemorrhoids and the diarrhea and was not sure it was related to the Covid Vaccine and possible being an intestinal flu but I felt like I needed to report. I also had nausea and vomiting the evening of 12/26/20 lasting about 12 hours. It took me a few days of Zofran and Imodium to get it in control and the bleeding did stop by 12/27/20.
62 2021-01-06 pain in extremity Very sore arm, unable to lift or move, stiff neck
62 2021-01-07 numbness 10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on r... Read more
10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on road, my tongue started to tingle and then my lips started to tingle and both sides of face felt numb. This started around 10:50pm? Went to bed and woke up Sat with same tongue, lip tingleling and face numbness. Lips felt very swollen. Felt that way throughout the weekend. On Monday, went back to work place injection area and requested someone talk to me. Nurse practioner came out and spoke to me, asked about balance of facial features, no problem breathing or swallowing and gave me 25mg benadryl to take 3 times a day. Did nothing but make me sleepy. She calls me Tue am and told me to make an appt with PCP. Made phone appt for Wed. Dr calls me Wed am and gives me presciption for 60mg Prednisone to take for a week (at this time symptoms are the same). the first 3 days taking Prednisone the intensity of tingleling seems to lessen day by day. But on 4th day, the symptoms stopped lessening. Finished the meds anyway. Last 3 days, i've also had that mild headache back in addition to the numbness from face traveling up to my ears. Past few days the tingling in tongue isn't confined to just the edges of the tongue. It started with the first 1/4 of whole tongue and is today tingleling in the front half of whole tongue. One good thing so far is the past few days, my lips feel way less swollen and tingleling is lessening. So, riding this out, hoping it will end sometime this year. Will not be getting the second shot. Just so you know.
62 2021-01-07 pain in extremity Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day... Read more
Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint); slight nausea/nausea; slight fatigue; slight headache; slightly stiff neck; right arm pain; The muscles knot up under her rib cage/muscle tightness; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscularly in the left arm on 29Dec2020 at 06:30 at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VIT D), levothyroxine (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy from an unspecified date to an unspecified date, influenza vaccine (FLU VACCINE) for an immunization on an unspecified date (received within two weeks of vaccination). The patient experienced the following events and outcomes: muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint) (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight nausea/nausea (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight fatigue (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight headache (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slightly stiff neck (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, right arm pain (non-serious) on 30Dec2020 with outcome of unknown, back pain (non-serious) on 31Dec2020 with outcome of unknown, the muscles knot up under her rib cage/muscle tightness (non-serious) in Dec2020 with outcome of unknown. The patient received the COVID-19 vaccine on 29Dec2020 at work, and she had been experiencing adverse events since. The worst side effect she was experiencing was muscle tightness. At the time of the report, the patient got up at 09:00, and her "back was killing her." The patient was achy. The patient would tighten up really tight under both rib cages, and it made her nauseous. The patient had been taking ibuprofen (ADVIL) and ibuprofen (MANUFACTURER UNKNOWN since she received the vaccination. The patient received the vaccine in her left arm, but her right arm hurt the next day. The next day after that (30Dec2020) she woke up and the right side of her back around the kidney area hurt. It was the right side lumbar. The next morning after that, "her entire back was killing her down the middle of her spine. From her head all the way down." Since then, it came and went. The patient could not say if it was persisting, improving or worsening for any of the symptoms. "It just grabs her." The day before the report, the patient thought she was doing better. The patient cleaned the house, and then sat down to eat. The past two nights, it had "hit her really hard during supper time." Both of her sides of her back would tighten up; "tense up like waiting for an impact before a wreck." The patient's back would seize up. The patient could not get comfortable; and would start pacing. Then, she would try to lay down. Last night, it took a half an hour to loosen back up. "It knots up like crazy. It was bad enough, she thought she was going to pass out." The patient did not know if it was the combination of eating supper or what. The patient thought if she got up that maybe she would feel better. The patient started pacing around. The patient went outside because she thought maybe fresh air would help. When it would tighten up under her rib cage, it made her nauseous. The patient did not know if it was a "vagus nerve thing or what." The patient was close to throwing up. The muscles knot up under her rib cage. The patient's back felt like she fell off a horse. It was weird to her that her left arm never bothered her. "Nothing stays the same." Sometimes it was her entire arm or part of the arm that hurt. Like on top of her forearm. The patient thought she was doing good and then it would come back. When she moved her arm upward, she felt it. The patient said she could deal with the arm pain. It was the knotting up pains that were the worst. The patient tried calling an institute (name withheld) because it happened while eating dinner the other night. The institute (name withheld) "nurse was useless." The pain was across her sacroiliac area. The patient had been "living on Advil and ibuprofen for her back pain." The patient had been taking them together. The patient worked nights, and she was planning on going to work the night before the report, but she had to text her boss and tell her she could not come in. The patient was in good health; had perfect blood pressure and her sugar was normal. The patient was not diabetic. The patient's labs were always normal. The patient was really dreading that second shot. "The flu shot kicked her butt for a couple of days, but this was way worse." The patient started reading up on the COVID vaccine, and it said usually younger people had severe side effects. That old people have less of a response. The patient did not know why she was experiencing such side effects. At the time of the report, it was day 7 or 8, and she was still feeling bad. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
62 2021-01-07 flushing My body had started itching and I didn't know why. I had not eaten anything new or changed any sha... Read more
My body had started itching and I didn't know why. I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially around my ankle, knee, under arm and goin area. I took an allergy pill and called Kaiser and spoke with an advice nurse. she mentioned that taking an allergy pill will relief some of the itching. I fell asleep around after midnight normally I go to bed around 9:30. I also called pfizer and explained and the person took all my information and symptoms.
62 2021-01-07 feeling hot Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and h... Read more
Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and headaches which seemed to move around my body for about 24 hrs. At one point it seemed to settle into my hand. Knuckles swelled arthritis like. When walking up stairs I had significant muscle weakness in my legs and exertional dyspnea. Eyes felt "feverish" but had no fever. The next morning while trying to do a routine workout the same thing happened. It was a significant change to my normal condition. The dyspnea was the most concerning. The body aches settled into my lower back. Fatigue was moderate-moderately severe. As the day went on things waxed and waned. By the end of 72 hrs. most symptoms subsided. Friday 01/08/2021 I had a completely normal workout, no exertional dyspnea, fatigue subsided, no body aches. Back to normal. I would consider the symptoms to have been Moderate+.
62 2021-01-07 feeling hot, flushing Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observatio... Read more
Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA
62 2021-01-07 weakness Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore th... Read more
Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
62 2021-01-07 weakness body aches, low grad temp, nausea that led to one episode of dry heave vomiting, weakness & fatigue
62 2021-01-09 tremor About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the... Read more
About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.
62 2021-01-10 weakness Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The ... Read more
Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The pain was terrible as was the fatigue and fever . I used Ibuprofen. 48 hours later I felt almost completely normal- no pain etc . Then 56 hours later resumption of chills fever for 4 hours . At 64 hours and after ibuprofen feeling better
62 2021-01-10 feeling hot, muscle spasms, tingling, hot flush, burning sensation Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tinglin... Read more
Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tingling in r hand, dizziness and chills throughout the day They would come and go. Late afternoon, Biceps went into spasms all fingers aching. After nap at 06:00 woke up and all symptoms gone. On 01/10/2021, woke up with tingling and burning from bilateral knees to toes. Lasted 2 hours and then gone. In afternoon 1 episode of dizziness and hot flashes followed by chills. 01/11/2021 Slight headaches. No bodyaches or other symptoms.
62 2021-01-10 tremor, weakness shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever... Read more
shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
62 2021-01-11 numbness 20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of so... Read more
20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of sorts. Feels like flu shot.
62 2021-01-11 tingling Immediate numbness/tingling in left arm and left hand and both feet. Left arm/hand symptoms lasted... Read more
Immediate numbness/tingling in left arm and left hand and both feet. Left arm/hand symptoms lasted ~15 minutes. Symptoms in both feet lasted 5-6 hours and continue intermittently.
62 2021-01-11 facial pain, feeling hot became hot and dizzy and stated she had some facial pain. further assessment determined the respons... Read more
became hot and dizzy and stated she had some facial pain. further assessment determined the response to be a vasovagal response.
62 2021-01-11 tingling pateint received vaccine and about 15 minutes later felt a heaviness in her arm and some pins and ne... Read more
pateint received vaccine and about 15 minutes later felt a heaviness in her arm and some pins and needles sensation in hand, arm and left leg. NO rash, no itching, no notable other side effects; denies palipations, shortness of breath, no pain , no hives, no cough or swelling
62 2021-01-11 pain in extremity, discomfort, difficulty speaking some congestion that just came on; her arm was really aching after the injection; she started coughi... Read more
some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
62 2021-01-11 pain in extremity some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was real... Read more
some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.
62 2021-01-12 pain in extremity 1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itch... Read more
1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills
62 2021-01-12 unresponsive to stimuli, tremor No adverse effects from vaccination seen on 1/2/21. On 1/6/21 resident was seen by Dr and her bacl... Read more
No adverse effects from vaccination seen on 1/2/21. On 1/6/21 resident was seen by Dr and her baclofen pump was refilled with 20 ml Baclofen 4,000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous rate over 3 days. On 1/8/21 at 0615 resident was shaking, lower extremities mottled, Sa02 70%, pulse 45. Oxygen started at 2 L/m per NC. At 0715 her primary physician was notified as well as her daughter. Oxygen increased to 4 L/min, sats at 83%. SOA noted, reported all over pain. At 0850 when they attempted to reposition the resident, she was not responsive. Licensed nurse assessed her and no heartbeat heard or pulse found.
62 2021-01-13 feeling hot 0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. E... Read more
0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. EMS ON SITE. VS: 168/71, p: 58; 97% O2 SAT R.A.; 0954: BP: 168/71, P: 58, 98% 02 SAT R.A. 1015: LEFT AND WENT TO HOSPITAL. ALERT, ORIENTED
62 2021-01-13 muscle spasms Got first dose around 3pm Jan 12. Foot cramp around 10:30pm. Took magnesium. On Jan 13, Brief dizzy ... Read more
Got first dose around 3pm Jan 12. Foot cramp around 10:30pm. Took magnesium. On Jan 13, Brief dizzy spell 7am (a few seconds); minute long dizzy spell around 3pm, another around 3:15, then a 2-hour long dizzy spell beginning around 3:30pm. Queasy till 9 pm, but no vomiting. Foot cramp again, so I got up and drank more water and took magnesium. Felt steadier.
62 2021-01-13 pain in extremity Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night af... Read more
Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night after shot. All gone by next morning with the exception of the headache, which is not as severe now.
62 2021-01-13 pain in extremity Sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female pati... Read more
Sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0140, expiration date unspecified), intramuscular on 28Dec2020 at single dose at left arm for COVID-19 immunization. Medical history included depression and anxiety. The patient was not pregnant and had no known allergies. The patient had no allergies to medications, food or other products. Concomitant medications were not reported. On 29Dec2020, the patient experienced sore arm. The patient did not received therapy for the event. The most recent COVID-19 vaccine was administered at the hospital. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
62 2021-01-13 pain in extremity Soreness in the arm , sore throat Mild fever, Pain at the injection site. Headache that
62 2021-01-13 feeling hot WARM FEELING IN CHEST AND THROAT DENIES ANY DIFFICULY SWALLOWING. HAPPENED 5 MINUTES AFTER INJECT. B... Read more
WARM FEELING IN CHEST AND THROAT DENIES ANY DIFFICULY SWALLOWING. HAPPENED 5 MINUTES AFTER INJECT. BP RANGING 140/60, O2 100. OBSERVED FOR 25 MINUTES. SYMPTONS REMAINS THE SAME SENT TO ER FOR FURTHER OBSERVATION.
62 2021-01-13 feeling cold was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was f... Read more
was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was freezing; felt chills/chill became a bone chill, and she was freezing; randomly felt miserable/she felt like her body was purging/feeling "blah"; she wasn't really eating; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration in her right upper arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Vaccination Facility Type is hospital and which was not a facility. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing and it was maybe 10 years ago that she was diagnosed, and she was treated for her diabetes. There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine (within 4 weeks) or additional vaccines administered on Same Date of the Pfizer Suspect. The patient received the first dose of the COVID-19 vaccine 22Dec2020 and is due for her second dose this upcoming Tuesday, 12Jan2021. She asked if it would be safe to receive the second dose at a different time, due to personal plans. She said after she received the first dose of the COVID-19 Vaccine on 22Dec2020, she was feeling sick in Dec2020. She said she had vomiting, chills, and randomly felt miserable, fatigue from 23Dec2020. She said she was nervous about getting the second dose of the COVID-19 Vaccine on Tuesday, 12Jan2021. She said she had plans around that time period and she was afraid she was going to be sick after she receives the second COVID-19 Vaccine dose. She asked if the second COVID-19 Vaccine dose had to be administered in the timeframe that was scheduled. The patient reported she felt chilled when she woke up the next morning, 23Dec2020. She said at first she thought she felt chilled because it was cold outside. She said after she arrived at work on 23Dec2020, the chill became a bone chill, and she was freezing. She said she realized the chill was not a normal cold feeling. She said by mid-morning on 23Dec2020, she began to vomit, and went home and went to bed. She said she got sick 2 more times that day. She said she went to work on Thursday, 24Dec2020, and randomly got sick. She said she wasn't really eating at that point (Dec2020), so it was not like she got sick before or after she ate something. She said she continued to get randomly sick through holiday, 25Dec2020. She said she felt like her body was purging. She said she was feeling "blah", but she was not bedridden or out of commission. She said she had no fever that she knew of. She said her symptoms resolved right after holiday, clarifying she started to feel like herself, saying she felt good. The patient declined any treatment and reported she didn't think her symptoms were that severe, though her family wanted her to go to the doctor. There was nothing had changed in her routine prior to receiving the first dose of the COVID-19 Vaccine. Reported she had blood work every 4 months, and her last blood work was probably done in Oct2020 or Nov2020. The events did not require a visit to emergency room or physician office. The outcome of the event feeling sick, she wasn't really eating, were resolved in Dec2020, outcome of fatigue, felt chills/chill became a bone chill, and she was freezing were resolved on 23Dec2020, outcome of vomiting, randomly felt miserable/she felt like her body was purging/feeling "blah" were resolved on 25Dec2020, outcome of fear and nervous were unknown.
62 2021-01-14 pain in extremity Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. ... Read more
Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--
62 2021-01-14 pain in extremity Body aches, chills, cough, headache, nausea, soreness and swelling of L arm pit.
62 2021-01-14 pain in extremity Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due t... Read more
Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due to heart rate.
62 2021-01-14 pain in extremity She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that e... Read more
She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that evening and started having severe pain in calf of her left leg no redness ,no heat, just hurt to work 1/8/2021 She had surgery on her left leg. 2nd Covid Vaccine received on 1/12/2021 She said she had PT on her right leg with severe pain in her left calf She said she did not have any therapy on her left leg. Two ? three hours later she developed chills, temp 100.1 took temp again later is was 99. She had ultrasound that showed a large blood clot She said the PA told her the blood clot could be from receiving the Covid vaccine
62 2021-01-15 feeling cold, weakness, flushing Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = ... Read more
Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.
62 2021-01-16 numbness Left sided facial numbness mildly affecting left lip, cheek and area around left eye. Lasted le... Read more
Left sided facial numbness mildly affecting left lip, cheek and area around left eye. Lasted less than an hour. Continued symptoms 48 hours after vaccine are moderate persistent headache, moderate fatigue. Feeling of not well. taking tylenol.
62 2021-01-16 pain in extremity chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fa... Read more
chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fatigue, congestion
62 2021-01-17 tremor Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right a... Read more
Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right after vaccine Full body pain daily mostly in the lower back
62 2021-01-17 pain in extremity I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflam... Read more
I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflammed arm over deltoid muscle that resolved after 3 days. Second dose given 21 days later- some swelling and soreness, low grade fever. Then 3 days later, I awoke, turned in bed and experienced an intense shearing pain in my neck and arm. The pain was the worst ever felt, and was not improved with NSAIDS, Acetaminophen, Hydrocodone, or Tramadol. I went to an urgent care center on 1/16 where a tentative diagnosis of sprained neck was made. The sypmptoms continue with slight improvement with steroids, and a muscle relaxant. I am concerned because I understand that covid itself can impact the nervous system considerably. I am awaiting improvement in symptoms and if none seen then I will see my primary care MD
62 2021-01-17 tingling I started running a low grade temp about 9 pm on 1/6/2021. Woke in a.m. (early) with 100.9 temp and ... Read more
I started running a low grade temp about 9 pm on 1/6/2021. Woke in a.m. (early) with 100.9 temp and swollen lymph nodes under my arm and along the side of my breast and a tingly right hand. Fever broke early am on friday (1/8/2021). I was very fatigued and tired and still had a very tingly hand on 8th. Tingly slowly got better and I didn't notice it anymore on Wednesday ,13th. Fatigue was better by Sunday the 1/9th. I felt pretty much back to normal by 11th except for my hand. No treatment.
62 2021-01-17 pain in extremity Left arm sore 2 days, 3rd day left neck, shoulder, arm , shoulder blade pain. Symptoms have not reso... Read more
Left arm sore 2 days, 3rd day left neck, shoulder, arm , shoulder blade pain. Symptoms have not resolved 1/18/2021, not as painful now advil and massage therapist therapist treatment
62 2021-01-17 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:0... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:00pm (shot was at 215pm). Upon awakening 1/19 at 6:00am, arm continued to be sore and I had fever registering at 102.5. I took two Tylenol then and again at 3:00pm. Headache appeared around 9:00am and was gone by 7:00pm. Temp began to decrease at 10am, to 101.1 and was 99.3 at 2:30pm. Sunday morning woke up with no soreness in arm or fever/headache.
62 2021-01-18 weakness Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going... Read more
Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going over the top half of arm around the injected area. chills , body aches, fever. stayed in bed the next 3 days. 4 day sweating, and low grade fever , fatigue very weak.
62 2021-01-19 seizure Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ... Read more
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
62 2021-01-19 burning sensation Severe burning sensation to left arm pit area
62 2021-01-20 discomfort "pains in my stomach on the left side from under my breast to my umbilicus. they are not intestinal,... Read more
"pains in my stomach on the left side from under my breast to my umbilicus. they are not intestinal, but more superficial. It is a general soreness with periodic stabbing pains." --still continuing after 5 days post vaccination
62 2021-01-20 flushing rosacea flare up; facial flushing; This is a spontaneous report from a contactable consumer (reporte... Read more
rosacea flare up; facial flushing; This is a spontaneous report from a contactable consumer (reported for himself). A 62-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1658), via an unspecified route of administration on 06Jan2021 12:15 at single dose at left arm for COVID-19 immunization. Medical history included asthma; osteoporosis; dry eye; Known allergies: Omnipaque CT injection fluid; environmental allergies including pollen and dust mites; rosacea he had many years ago including facial redness and burning. Concomitant medication included fluticasone propionate (FLOVENT). The patient previously took denosumab (PROLIA) injection last taken on 06Aug2020. Facility type vaccine was Hospital. No other vaccine in four weeks. About eight hours after the injection the patient started having facial flushing and was advised to go to an emergency room. Patient saw Dr. (Name) at (Institution name) who prescribed Benadryl, Prednisone and Pepcid and the facial flushing subsided but came back the next day. The patient had been experiencing a recurrence of symptoms due to a rosacea flare up that he had many years ago including facial redness and burning. Adverse events start date on 06Jan2021 20:00 and resulted in Emergency room/department or urgent care. The patient didn't have COVID prior vaccination and didn't have COVID tested post vaccination. The outcome of the events was recovered with lasting effects.
62 2021-01-20 tingling, flushing, numbness tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand... Read more
tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; palm of left hand was itchy; inside of nose; it feels like someone is pinching nose/It's swelling; inside of nose; it feels like someone is pinching nose/It's swelling; face has a rashly feeling; This is a spontaneous report from a contactable consumer reported for self. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose in left arm for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient reported that she had the vaccine at her work, waited 15 minutes and left the clinic. About 20 minutes then, her tongue was itching, lips were itching; face felt flushed. Face had a rashly feeling. Her left hand was tingling or numb (the palm). Her palm of left hand was tingling and itchy. The inside of nose; it feels like someone is pinching nose. It was swelling. The patient stated "Whenever I get stung by bees, this is how I feel". The patient stated that it was mild. She stated she was having a reaction, but not severe enough maybe it will subside. Her left arm is where she got the injection and it was left hand that was puffy and tingling. The patient stated that she also had N95 mask on and she guess she get that reaction from it. The patient stated that she was just wondering what she should do, if she should just go by some diphenhydramine hydrochloride (BENADRYL). The outcome of events was not reported. Information about lot/batch number has been requested.
62 2021-01-21 flushing, speech disorder, weakness A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm t... Read more
A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.
62 2021-01-24 weakness 1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing... Read more
1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing for last 10 days Still low grade fever 99.8 and cough headache body aches weakness fatigue short of breath
62 2021-01-24 muscle spasms Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; ... Read more
Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
62 2021-01-24 weakness Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal f... Read more
Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal flu coming on, weak and dizzy. I felt that way for approximately 20 minutes and went lie down but began to feel more dizzy and then very nauseated. I then vomited several times and afterward began to feel steadily better. The whole even was approximately 2 hour before I felt back to normal.
62 2021-01-24 tenderness Pain and very tender to touch in left clavicle area.
62 2021-01-24 feeling hot Tachycardia and hypertension feels hot and heart rate was high
62 2021-01-24 feeling cold, weakness Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulenc... Read more
Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
62 2021-01-24 pain in extremity arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten wo... Read more
arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten worse on day 3 post vaccine and not relieved by acetaminophen
62 2021-01-24 pain in extremity, muscle spasms joint pain; bad back spasms in the middle of the back radiating up through right should to right arm... Read more
joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No. Information on the Lot/Batch number has been requested.
62 2021-01-25 tingling Client approached a Public Health Nurse after 30 minutes of waiting and stated her hands felt itchy,... Read more
Client approached a Public Health Nurse after 30 minutes of waiting and stated her hands felt itchy, prickly, and were reddened. Denied SOB and denied chest pain. Benadryl was offered and taken, client felt better after that and was released, offered a ride home, but left with a friend.
62 2021-01-25 numbness, pain in extremity started last week feeling numbness in my right foot. Then went to my right leg and up to my right a... Read more
started last week feeling numbness in my right foot. Then went to my right leg and up to my right arm and hand . Then went to the left arm. Starting to have pain in my right hand and leg. The numbness grew daily. When i stand the numbness goes away and then when i lay down or sit down it comes back.
62 2021-01-26 tremor Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs.... Read more
Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs. Finally back to bed to continue with violent shakes. fever, aches and head aches lasting until late Thursday afternoon. Exhausted feeling still remaining through Saturday. Felt myself on Sunday 1/24
62 2021-01-26 pain in extremity The next day after the vaccine my arm was red and really painful. Each day the redness got larger a... Read more
The next day after the vaccine my arm was red and really painful. Each day the redness got larger and by friday it was near my elbow so I went to an Urgent Care. I was given a prescription for an antibiotic because they states infection had set in it and I also took tylenol and antihistimines to help with the pain.
62 2021-01-26 pain in extremity Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph ... Read more
Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph nodes left axillary area. Fatigued. Headache became debilitating around noon. Extra strength Tylenol decreased temperature and body aches but did not help with headache. Fatigued all day. 1/27/21 10amFatigued, headache, body aches gone.
62 2021-01-26 pain in extremity bil arm pain, bil wrist pain, mild joint pain
62 2021-01-27 pain in extremity Starting the day after the injection she is having very sore legs and it hurts to walk.
62 2021-01-27 pain in extremity The day after the injection her legs are very sore and she is having pain walking.
62 2021-01-27 pain in extremity Vaccine given high up on shoulder, not 3 finger widths down. Persistent pain right shoulder and uppe... Read more
Vaccine given high up on shoulder, not 3 finger widths down. Persistent pain right shoulder and upper arm, positional discomfort. Pocket of fluid accumulation above right clavicle.
62 2021-01-27 flushing approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 ... Read more
approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 97, p=101, pt reports that this bp is "normal for her", she remained alert aned oriented, progressed to feeling "flushed from head to waist", at 5:05 pm, pt feels that these s/s r/t "very busy all day,this is the first time I have sat down all day", bp 168/95, 103, spo2 96, cool pack applied to back of neck, pt reports increase in feeling , "flushed", 1720- pt c/o "my neck feels swollen, my jaw hurts", denies shortness of breath, or chest pain, no hives observed on head, or abd, pt agrees to more advanced eval at ER, husband notified, 1730, pt experiences dry heaves, no emesis, bp 179/109, Ambulance called to transport to ER, IV initiated by EMT, 1740, pt to stretcher, with ambulance crew, report given, pt continues to deny shortness of breath, and chest pain, she remains alert and oriented.
62 2021-01-27 tremor approximately 10 minutes after receiving vaccine patient complained of fullness in throat and diffic... Read more
approximately 10 minutes after receiving vaccine patient complained of fullness in throat and difficulty swallowing, also felt tremulous and like heart was racing, some visible swelling of lower lip, initial vitals revealed pulse ox of 99, bp 151/70 and hr of 107, lungs clear without wheezing, no urticaria, given 25mg po Benadryl with gradual resolution of symptoms and normalization of vital signs
62 2021-01-27 migraine migraines; arm is sore where the injection; she could hear like blood going through her, and if she ... Read more
migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.
62 2021-01-28 tremor shaking, dizziness
62 2021-01-28 tremor shaking, dizziness, felt bad right after injection
62 2021-01-31 weakness, tremor, inability to speak, numbness (Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point... Read more
(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.
62 2021-01-31 numbness The vaccine was administered in my left arm, but my right hand started feeling numb. It only lasted... Read more
The vaccine was administered in my left arm, but my right hand started feeling numb. It only lasted about 30 mins and I was able to drive home, but it was very weird and unexpected.
62 2021-01-31 inability to speak she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transpor... Read more
she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transported to the hospital. i was told she had tested positive for COVID 2 times once at the home and once at the hospital. with in 2 DAYS at the hospital she wa on a ventilator 2 days later she died. i talked with the rehab center and confirmed she tested negative for COVID on Dec 27th 2020 and was given the Vaccine on the 29th Dec 202 was in the hospital 4 day later, was on a ventilator 4 days after that then died a few day later as her heart stopped beating. all the while i had POA and was not contacted by Hospital staff until after they had made the next step.
62 2021-02-01 weakness racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60)... Read more
racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60); Very weak; chills; whole body achiness; This is a spontaneous report from a non-contactable nurse (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176) via an unspecified route of administration on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included coronavirus and allergies: sensitive to milk protein and gluten sensitivity. Concomitant medication included St John's Wort, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium carbonate (TUMS [CALCIUM CARBONATE]) and multivitamin. The patient previously took casein and experienced allergies. On 19Jan2021 05:00 AM, the patient experienced racing pounding heart rate 110-126 (normal is 60), very weak, chills, whole body achiness. Work the night shift, 11p-7a and symptoms started around 5am. No treatment was received for the events. Patient was not pregnant. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
62 2021-02-03 muscle spasms 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headac... Read more
101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
62 2021-02-03 weakness Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye a... Read more
Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye and nose; burning eye and nose; weakness; tiredness; sore lips and throat; sore lips and throat; sore on tongue; chest tightness; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, high cholesterol, diabetes mellitus, allergies penicillin. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included atenolol (manufacturer unknown), losartan (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazid (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 07:00 the patient experienced dizziness, nausea, headache, constant eye and nose drain, burning eye and nose, weakness, tiredness, sore lips and throat, sore on tongue, chest tightness. The patient underwent lab tests and procedures which included Sars-cov-2 nasal swab test: negative on 19Jan2021. The outcome of all events was not recovered as all ongoing now for 1 week. The events were considered non serious. Information on the lot/batch number has been requested.
62 2021-02-03 weakness chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weaknes... Read more
chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.
62 2021-02-03 tingling headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consume... Read more
headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on the right arm on 10Jan2021 at 09:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730 on 20Dec2020 at 09:00 AM on the right arm for COVID-19 immunization, and Benadryl. The patient took Benadryl before the second dose and throughout the day, and it somewhat helped with the constant skin irritation. On 10Jan2021, the patient experienced headache, itchy and prickly skin all over her body. No admission to hospital involved and no treatment was received. The events resolved on an unspecified date in 2021.
62 2021-02-04 weakness Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible... Read more
Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21
62 2021-02-04 numbness Numbness in the left arm and left hand for about 2.5 days. Severity lessened as days progressed
62 2021-02-04 pain in extremity soreness in arm, bad headache, nausea, itching on head, face and upper body.
62 2021-02-04 pain in extremity soreness in arm, headache
62 2021-02-05 tingling Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus heada... Read more
Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus headache for a couple of days, low grade fever for about 12 hours , achy all over felt like pin pricks up and down my body to the bottoms of my feet. At one point my air passage felt blocked possibly by something that I threw up.. had trouble regaining my breath. I was surprised at how fast and furious this came on.
62 2021-02-05 weakness Fever x 3 days Weakness, fatigued, achy Urinary Incontinence day 1 Brain fog
62 2021-02-07 weakness extreme weakness; increase in my spasticity; This is a spontaneous report from a contactable healthc... Read more
extreme weakness; increase in my spasticity; This is a spontaneous report from a contactable healthcare professional (patient herself). A 62-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 16:15 at single dose for covid-19 immunization. Medical history included MS (multiple sclerosis); kidney disease. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included glatiramer acetate (COPAXONE) from 19Jan2021, escitalopram oxalate (LEXAPRO) and antihistamine, magnesium. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme weakness and an increase in her spasticity related to MS on 20Jan2021 12:00. Since the vaccination, the patient had not been tested for COVID-19. The events were reported non-serious. Outcome of events were recovering. No treatment was received for the events. Information on the lot/batch number has been requested.
62 2021-02-08 pain in extremity heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This i... Read more
heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 62 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) administered on 30Dec2020 at 01:00PM and the patient said she did not have a reaction after the first vaccine. The patient received no concomitant medications. She stated that she had no other recent vaccinations or new medications. One thing that may be important is that she did do a 7 day detox that ended the Sunday before her second vaccine dose, so her body was pretty much having no impurities in it, and she has been eating clean since then, maybe having something foreign put into her body set it off after detox. The patient experienced arm soreness and general fatigue on 21Jan2021, and on 22Jan2021 at 01:00 she experienced severe nausea and heart rate of 160 (which was reported serious as medically significant). Patient reported that after her second dose of the COVID-19 vaccine she had a significant side effect that didn't happen until 10-12 hours after getting the vaccine. She did not have a reaction after the first vaccine. After the second injection her arm was sore, and she had general fatigue. She had the second dose injected Thursday at around 01:00PM, then at one in the morning her heart rate was 160, and she had severe nausea. She was that way until 08:00AM. Her heart rate was 120 probably by 09:00AM, then came down to 100, she has never had anything like that before. Her arm soreness was a deep muscle soreness to her left arm. The fatigue was a couple hours later after she got the second dose of the vaccine. The nausea started at 01:00AM, and lasted until six to eight, she did no treatment, and it improved and is still gone now. For her heart rate of 160, she had no treatment, though she probably should have gone to the hospital, but it came down. She usually runs a heart rate of 60-70, it went back to normal Friday, probably in the afternoon on the 22nd, about 12 hours after that started. The patient stated that she feels this is medically significant for her heart rate to be that high. She had contacted her primary care physician (PCP), but they didn't call her back for 4-5 hours, by then she was fine. She doesn't think that this was treated well by her PCP, and that they should have done an electrocardiogram (EKG) and follow up labs, she is changing her PCP as a result of this. She is concerned about the people who will be getting their second dose, she has been helping with these, they have patients that are over 100, they wouldn't survive that rapid heartbeat. The outcome of arm soreness/muscle soreness and fatigue was unknown.; Sender's Comments: The reported event of heart rate increased was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
62 2021-02-09 tremor Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date... Read more
Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.
62 2021-02-10 muscle spasms collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and s... Read more
collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats. After coming too, drank electrolytes and water. The patient got the chills after sweating. It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.
62 2021-02-16 facial pain Woke up one morning w/pain/ache in left lower jaw/back teeth, especially w/opening my mouth. Chewin... Read more
Woke up one morning w/pain/ache in left lower jaw/back teeth, especially w/opening my mouth. Chewing on back molars hurt. As time went on pain worsened and radiated into my cheek, left eye and left ear. ~ One week later, I saw a dentist; he couldn't say whether it was TMJ or tooth problem, so sent me home w/quick splint to separate my top & bottom teeth at night and some exercises. These didn't help, so ~ a week after that, he gave me antibiotic. No improvement in symptoms until ~ a week after that. I saw pcp, as it felt like something was crawling inside my left ear. Ears were fine; she agreed w/inconclusive answer of dentist - at this point, there was some improvement in my symptoms. She suggested prescription-strength Naproxen for 10 days, which I did. the pain/ache has been mostly gone since completing the Naproxen. For last few weeks, I've been back to normal - no ache/pain/strange sensations in ear at all.
62 2021-02-17 weakness The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperatu... Read more
The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
62 2021-02-21 facial pain, pain in extremity The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teet... Read more
The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.
62 2021-02-22 tingling Body aches, low blood pressure, tingling sensation in hands, symptoms lasted for a week.
62 2021-02-24 burning sensation Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also report... Read more
Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also reports itching and burning sensations in affected area. Patient went to urgent care (2/25/21) and was diagnosed with shingles. Patient was prescribed valtrex.
62 2021-02-25 flushing Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and ... Read more
Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and cheeks, elevated blood pressure 138/115 to 140/73
62 2021-02-25 weakness, tremor body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, t... Read more
body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, thirst, shaking, feeling of crawling out of body. Lasted 3 1/2 days. Last 2 days shaking and crawling out of body feeling was not present. Diarrhea only day 1. Nausea lasted 1 1/2 days. Day 4 no adverse effects remained. Not certain if the above was related to vaccine but timing seemed to match.
62 2021-02-26 pain in extremity Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within ... Read more
Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within a few days it was painful to move my arm backward, upward and forward. The pain lasted over a week; I contact Primary Physician and he recommended ice and acetaminophen. I did that for several days and by day 10 it was spreading to my shoulder area and radiating down my arm. On 2/25 I went to urgent care (primary is 50 miles) and then my Primary is preparing consult for Ortho.
62 2021-02-26 feeling cold For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my ... Read more
For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my temperature dropped to 93 degrees. When I finished with these symptoms my temperature climbed back up to 97.7. I have been having intermittent belly pains since then but they are nothing like they were last night and they are getting more mild and far between as I write this.
62 2021-02-27 tenderness Experiencing swollen, very tender lymph nodes under armpit. Taking Tylenol for pain. Symptoms are g... Read more
Experiencing swollen, very tender lymph nodes under armpit. Taking Tylenol for pain. Symptoms are getting better.
62 2021-02-27 pain in extremity Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with... Read more
Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with Tylenol
62 2021-02-28 difficulty speaking Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoar... Read more
Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.
62 2021-02-28 tingling Tingling sensation on her fingertips, on the lower part of her face, and chin; Tingling in her tongu... Read more
Tingling sensation on her fingertips, on the lower part of her face, and chin; Tingling in her tongue and lip; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 26Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. The patient received the second dose of the COVID-19 vaccine in the morning of 26Jan2021. From that afternoon on (26Jan2021), the patient had tingling in her tongue and lip. The patient did not have this side effect before. The patient was also feeling it on the lower part of her face today (28Jan2021) and is also feeling a tingling sensation on her fingertips. The patient was now (28Jan2021) experiencing a tingling sensation on her tongue, lips, and chin and it doesn't go. The patient wanted to speak with someone to ask if this is a normal side effect or if she should be concerned. The patient was asking what she can do about this. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
62 2021-03-01 bell's palsy Bell?s Palsy
62 2021-03-01 numbness Throat tightness, dry mouth, numbness in L arm- evaluated by EMS-cleared
62 2021-03-02 weakness Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like... Read more
Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like I had a hangover; Lethargic all day; Fever 99.5-100.2; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of BNT162B2 (lot number: El9265), via an unspecified route of administration on 29Jan2021 13:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included levothyroxine sodium (UNITHROID). The patient previously took first dose of BNT162B2 (lot number: El324) at the age of 62 year-old on 08Jan2021 13:00 in the left arm and experienced minor injection site soreness. On 30Jan2021 07:00, the patient experienced headache upon waking Saturday morning and felt like she had a hangover. She felt lethargic all day. She had fever 99.5-100.2 from 7pm- 9pm on Saturday night. She experienced body aches on Sunday morning, 31Jan2021. Puttered around the house, then lost energy around noon. She felt ok but not back to normal energy level yet. Stated she is going to work tomorrow. The patient was not pregnant at the time of vaccination. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 99.5-100.2 on 30Jan2021. The outcome of the events was recovered in Jan2021.
62 2021-03-02 pain in extremity One day after vaccine severe body aches and sore arm. I had covid 19 in October 2020 and found the b... Read more
One day after vaccine severe body aches and sore arm. I had covid 19 in October 2020 and found the body aches after the vaccine to be worse than having the virus itself. Second day after vaccine I noticed lymph node in my armpit to be very swollen. This was the same side of my body the shot was given. I am worried about getting the second dose but I am still going to get it.
62 2021-03-03 burning sensation 0430 AM WOKE WITH BURNING FEELING AND CHILLS. AT 0730 TEMP DONE SEVERAL TIMES. 104.9 ORALLY. CALL... Read more
0430 AM WOKE WITH BURNING FEELING AND CHILLS. AT 0730 TEMP DONE SEVERAL TIMES. 104.9 ORALLY. CALLS MADE TO CLINIC AND PCP. I REFUSED TO GO TO EMERGENCY DEPT (HOSPITAL WAS TOTALLY FULL AND SOME). ALL DAY FEVER, NEVER BROKE. SAT. 102-103 SUN. WOKE FEELING FINE.
62 2021-03-03 pain in extremity Extreme pain , weakness in right arm . Can?t lift arm . For two weeks already
62 2021-03-03 tenderness On or around December 22, I noticed pain in my left forehead as though someone had hit me with a bas... Read more
On or around December 22, I noticed pain in my left forehead as though someone had hit me with a baseball. The next week around the 29th, it got very noticeable - pain to the touch but no swelling. It continued. Between the first dose and second dose I didn't recover, it just stayed.
62 2021-03-03 weakness Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm coul... Read more
Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm. Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
62 2021-03-04 numbness, tingling Blood sugar rose to 501one hour after vaccine. It was 166 in the am Never has been that high Left a... Read more
Blood sugar rose to 501one hour after vaccine. It was 166 in the am Never has been that high Left arm vaccine rm tingled and numb all the way to finger tips
62 2021-03-04 flushing, weakness I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day... Read more
I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.
62 2021-03-04 pain in extremity My husband also had the same vaccine at the same time but did not experience my symptoms as describe... Read more
My husband also had the same vaccine at the same time but did not experience my symptoms as described below: Vaccination was given very high on the should blade instead of upper arm of left arm. After the injection on 2/27/21 arm was mildly sore, but on the third day, there was more pain. On March 3, the pain was worse, very painful to lift or bend left arm, constant throbbing pain, there is no inflammation on the injection site but whole left arm especially the injection site is very very painful. To this day, March 5, 2021 the pain and throbbing persists, It is very painful to lift or bend the left arm. Will start take OTC CVS Ibuprofen 200 mg every 6 hours to ease the pain.
62 2021-03-07 tingling, numbness, pain in extremity About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and ... Read more
About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and noticed numbness/tingling in my right little finger. I went to bed and woke up at around 2:30 AM, I had very hot, stabbing, shooting pain running up and down my arm into my neck and upper shoulder. I also had pain running down my arm. This pain was a 9/10 and lasted for 3-4 hours non stop. I was up most of the night and considered going to the ED. The following day, I still had numbness/tingling in my right little finger. I was able to move my arm a little more but not enough. The numbness/tingling took 3-4 days to go away and the arm soreness took 5-6 days to go away. I received the shot from a Pharmacy Intern. I do have shoulder problems but this was not normal. I am a RN. I am very thin, weighing around 107 lbs. I wondered about the technique used or the length of the needle, or the possibility that I was allergic to something in the vaccine. I was also very, very tired for 2-3 days. I do have a sore arm after the flu vaccine but not like this. I will not be receiving the second vaccine, even though I am immunocompromised. I did call my MD office but did not go in.
62 2021-03-07 pain in extremity Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable he... Read more
Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6201), via an unspecified route of administration on 05Feb2021 at 08:15 on the left arm at a single dose for COVID-19 immunization. Medical history included sleep apnea from an unknown date and unknown if ongoing and meningioma removal on an unspecified date, 3 years ago. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rapid heart beat, jitteriness, fatigue and sore arm on 05Feb2021 at 10:00. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
62 2021-03-08 pain in extremity, weakness Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my ... Read more
Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.
62 2021-03-08 muscle spasms Significant neck pain and muscle spasm 48 hours after vaccination, aseptic meningitis 3 weeks after ... Read more
Significant neck pain and muscle spasm 48 hours after vaccination, aseptic meningitis 3 weeks after vaccination requiring hospitalization.
62 2021-03-10 feeling hot After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stro... Read more
After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
62 2021-03-14 pain in extremity she felt something in her foot (right foot) under the toes like she had sept on something like the l... Read more
she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown. Information on lot/batch has been requested.
62 2021-03-16 slurring Started seeing her eye become bug eyes and hurting started to slur speech and not about to walk. Cal... Read more
Started seeing her eye become bug eyes and hurting started to slur speech and not about to walk. Called her neuro doctor on 3-1-21 he said to take her to the eye doctor so I did. They told me her eyes are dry to put eye drops in. Called her neuro next day he told me to take her to the ER. They diagnosed her with Graves Disease and now she is showing symptoms of Graves Disease. She has never had any problem with her Thyroid. Had blood work done back on Jan 20th 2021
62 2021-03-17 burning sensation, nerve pain, pain in extremity tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertip... Read more
tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
62 2021-03-23 hot flush, tremor Within 30 min of shot, starting feeling itchy tongue and throat. Drank water and within a few minut... Read more
Within 30 min of shot, starting feeling itchy tongue and throat. Drank water and within a few minutes got a full body heat flush and starting shaking all over. Heart beating fast and having some pain in chest. Drove to her work place and was assessed by MD and RN on staff. BP was 220/120, pulse over 100. She took a Claritin and was monitored in the work place. She became lethargic and chest pain continued so she went to the closest Emergency Room.
62 2021-03-27 pain in extremity Very itchy right eye, for 2.5 days, (same length of time as arm soreness), followed by sudden onset,... Read more
Very itchy right eye, for 2.5 days, (same length of time as arm soreness), followed by sudden onset, noticeable vision loss with diagnosis of epiretinal membrane and vision loss from BCVA from 20/20 or 20/40
62 2021-03-28 pain in extremity 1 week later, left calf pain, SOB
62 2021-03-28 unresponsive to stimuli Went to sleep with husband evening after vaccine and in the morning was found unresponsive with agon... Read more
Went to sleep with husband evening after vaccine and in the morning was found unresponsive with agonal breathing. Intubated in the field by EMS and taken to the hospital. At this time is still encephalopathic, on ventilator, s/p cardiac arrest.
62 2021-03-29 muscle spasms diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 ... Read more
diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 - 99.4; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Mar2021 09:30 (lot number: EN6204) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, migraines, and thyroid disorder. The patient's concomitant medications included cyclobenzaprine, levothyroxine, telmisartan (TELMI), and topiramate (TROKENDI XR). The patient previously took erythromycin and morniflumate (FLOMAX) and experienced allergies to both. The patient experienced severe stomach cramping, diarrhea with bright red blood, extreme nausea, back cramps, temperature range 97.4 - 99.4, so sick and she had to lay on bathroom floor throughout night on 10Mar2021 20:00. There was no other vaccine in four weeks. The patient was not pregnant at the time of report. Prior to vaccination, patient has no COVID and patient was not tested for COVID post vaccination. The vaccination facility type was Health Department. The outcome of the events were recovering.
62 2021-03-30 tingling difficulty swallowing; jaw got very sore like it started popping out of joint and couldn't open wide... Read more
difficulty swallowing; jaw got very sore like it started popping out of joint and couldn't open wide/large dime size knot on the left side of jaw right at tmj area; jaw got very sore like it started popping out of joint and couldn't open wide; tingling down left leg down to toes, left leg only/tingling on the left leg; large cyst on the left side of her jaw; sore right jaw with clicking sounds; large dime size knot on the left side of jaw, right at TMJ area;hardness; pimple; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN8203; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. There were no medical history and concomitant medications. On 04Mar2021, reports getting the vaccine on 04Mar2021 and has had a large cyst on the left side of her jaw, sore right jaw with clicking sounds and tingling on the left leg, an hour and a half after. Also reported difficulty swallowing. Reported that she had reactions, not immediately, but 1 hour and 15 minutes after the vaccine. Caller reports a large dime size knot on the left side of jaw, right at temporo mandibular joint (TMJ) area. Injection was on left side. Caller reported that minutes later, her jaw got very sore like it started popping out of joint, and couldn't open wide. She also states that she had tingling down the left leg, down to the toes, left leg only. States this all happen pretty much right at the same time, maybe 5-10 minutes of each thing happening. She is at home with grandson. She was on hold for a while already. Weird reactions, not the common ones. States that she is not going to take the second vaccine, is afraid to take it. At this point, it is just a hard knot (described as a large dime size knot), and he (the doctor) said to take a Benadryl, which she did. Knot, hardness resolved gone by 06Mar2021, but a pimple remained for 7 days. The outcome of the event jaw disorder, jaw pain, was recovered on an unspecified date, for the event tingling of extremity was recovered on 04Mar2021, for the event large dime size knot on the left side of jaw, right at TMJ area;hardness was recovered on 06Mar2021, while unknown for the other events. No follow-up attempts possible. No further information expected. Batch/lot number already provided; Sender's Comments: Considering the close temporal association (reportedly, the reactions occurred hour and 15 minutes after the vaccine), a causal association between the reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
62 2021-04-10 tremor 2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days... Read more
2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days also then had chills hand tremors loss of appetite nausea this continued for 2 more months. I went to Urgent care and on March 26 then found a clot in my right lung. I am on warfin now and none of these symptoms did I have prior to the vaccine. I had 5 covid tests to see if I had COVID but all the tests were negative.
62 2021-04-13 one side paralysis Slight headache that day (4/1). The next day (4/2), weakness in left leg and arm. On 4/3 went to ER... Read more
Slight headache that day (4/1). The next day (4/2), weakness in left leg and arm. On 4/3 went to ER, admitted to NeuroScience ICU. Diagnosed with small blood clot and small bleed in brain--- dural venous sinus thrombosis. The neurology team said this was very unusual and very rare in this part of brain--where the blood flows back to the heart from the brain. They did alot of tests on every part of my body looking for the cause and found nothing. They think it was vacine induced and repoted it to the CDC. Left leg and arm weakness remains with no changes yet. Now taking blood thinner and doing physical therapy
62 2021-04-14 weakness Death SHORTNESS OF BREATH WEAKNESS - GENERALIZED
62 2021-04-17 weakness, pain in extremity, tingling eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy ... Read more
eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
62 2021-04-17 weakness, night sweats passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs... Read more
passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.
62 2021-04-23 unresponsive to stimuli -Patient died unexpectedly on Thursday, April 22, 2021 at her home (found unresponsive by spouse) -N... Read more
-Patient died unexpectedly on Thursday, April 22, 2021 at her home (found unresponsive by spouse) -No reactions were observed at the pharmacy (within 15 min waiting period) following either covid-19 vaccine (1st dose administered 8am on 3/26/21 -Left Deltoid) -When asked (4-16-21) how she tolerated the 1st dose, Patient reported minor side effects (mild Headache, tiredness) but had no reservations about receiving the 2nd dose. No additional information.
62 2021-04-24 numbness Severe anaphylactic-like reactions to foods started /Throat swelling, closing; Numbness of lower par... Read more
Severe anaphylactic-like reactions to foods started /Throat swelling, closing; Numbness of lower part of face; throat constriction, lasted for 45 minutes; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 10:00 AM as single dose in right arm for COVID-19 immunisation. The patient's medical history included auto-immune disease, RA, Hashimoto. Patient had no prior allergies except to bee venom. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. 60 minute after the shot, throat constriction, lasted for 45 minutes. On 20Mar2021, the patient experienced severe anaphylactic-like reactions to foods. Patient experienced throat swelling, closing, numbness of lower part of face which resulted in emergency room visit and physician office visit. Reactions are muted since taking antihistamines but persisted even on 08Apr2021. Adverse events treatment included Allegra, Zyrtec. All allergy tests were negative. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was not recovered.
62 2021-04-24 seizure, pain in extremity, tremor She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking,... Read more
She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking, she thought she was having a seizure with how bad she was shaking; Chills; Fever; sore hands and wrists; sore hands and wrists; totally exhausted; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 15:00 (Lot Number: EPT533) as single dose for covid-19 immunisation. The patient previously took flu shot. Medical history included diabeticc, thyroid is done, real bad psoriasis, high blood pressure, triglycerides, cholesterol , anxiety, to replenish potassium. Concomitant medications included metoprolol taken for hypertension; acetylsalicylic acid (ASPIRIN (E.C.)); citalopram taken for anxiety; amlodipine taken for blood pressure; hydrochlorothiazide; fenofibrate taken for blood triglycerides; atorvastatin taken for blood cholesterol; losartan potassium to replenish potassium; colecalciferol (VITAMIN D3); metformin taken for diabetes mellitus; levothyroxine; hydroxyzine; guselkumab (TREMFYA) taken for psoriasis,. The patient was shaking, she thought she was having a seizure with how bad she was shaking, chills, fever, sore hands and wrists, totally exhausted, diarrhea on 01Apr2021. The outcome of events chills, Wrist pain, Pain in hand was recovered on 05Apr2021; The outcome of event Fever and Diarrhea was recovered on 06Apr2021; outcome of other events was recovering.
62 2021-04-24 feeling of body temperature change, weakness cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose;... Read more
cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose; cold sores on lips after second dose; threw up after second dose; soreness after second dose; dizzy and weak after second dose; dizzy and weak after second dose; chills after second dose; sweating after second dose; dry heaving after second dose; nauseated after second dose; dehydrated after second dose; hasn't eaten for 5 days after second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FR8737and expiry date was not provided), via an unspecified route of administration, in left arm, on 07Apr2021, as a single dose (at the age of 62-years) for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection, lot number: EN6201 and expiry date was unknown), via an unspecified route of administration, in left upper arm, on 05Mar2021, as a single dose for COVID-19 immunization. The patient arm hurt after first dose (began immediately and lasted for about 4 days) which was resolved on 09Mar2021. Patient second dose was scheduled on 27Mar2021, but she did not get it till 07Apr2021. It was reported that on 08Apr2021, patient had such an awful reaction to the second dose of the vaccine. She started to get dizzy and weak, chills, everything was a blur, sweating, could not drink threw up if she tried dry heave went back to sleep and slept for 48 hours had just chills the whole time. She was in bed sleeping trying to drink, getting up to go to the bathroom and feeling like she was going to die for the next three days. She was nauseated and is still nauseated and could not drive. She took Tylenol an antiemetic at urgent care that stopped. She took Zofran with the saline solution infusion and she went home and slept. She was dehydrated and had soreness all over. On 09Apr2021, she could not roll over and had a sore on her left butt cheek that was still there cold sores on lips. She thought the sore on her left butt cheek came from laying in bed so much, and it was not in any other space but that one spot almost like she would have gotten the shot there, but she didn't. On 10Apr2021, patient felt like she was going to die, and went to urgent care and asked if they could give her fluids. They gave her fluids and Zofran and that helped a lot. This one shocked the hell out her, she thinks it was her gums that started to bleed on 11Apr2021. She had the best oral hygiene and went to the dentist all the time. She was flosses like crazy. She started to drink a ton of water and has not seen it since. She cannot guess what the reason was. On 11Apr2021, she could function a little and had chills again last night and sweating. She did not have a fever. She ate chicken noodle soup water and a little bit of ginger ale. She started to feel better, but not 100% better not even 90%, not even 80%, but was heading towards the right direction. Patient also hasn't eaten for 5 days after second dose. She experienced cold and hot. She was not complaining at all and she has been sick for days and cannot eat and will throw up but will gain it right back. The dizziness and weakness were subsided. She feels like she is getting beat up but is recovering. Patient thought that vaccine pulled out with a syringe and that's the problem everyone gets the same dose. Patient's weight was 136 or 138 lbs. Outcome of the events nauseated after second dose was resolved on 10Apr2021, and dizzy and weak after second dose was resolved on an unknown date in Apr 2021, and for the events chills and sweating it was recovering, and for all other events, it was unknown.
62 2021-04-24 weakness heart was fluttering and beating out of her chest; Elevated heart rate/The highest was 130; she felt... Read more
heart was fluttering and beating out of her chest; Elevated heart rate/The highest was 130; she felt her heart racing; Heart rate goes up and down; could not do anything and was laying in bed or on the couch; white blood cell count is higher than it should be; has allergies to medications but not what was in the Pfizer shot. She adds that maybe she had a reaction to the chemicals in there.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6206 and expiry date: was not provided), via an unspecified route of administration, in arm left, on 10Mar2021 at 03:30 PM, as a single dose for COVID-19 immunization, at hospital. The patient was not pregnant at the time of vaccination. The patient was tested for COVID-19, before the vaccination, however, results not provided. The patient has not been tested for COVID-19, after the vaccination. Patient's medical history included breast cancer survivor, chronic lymphatic leukemia. Patient had known allergies with penicillin and sulfa. Concomitant medications included calcium, colecalciferol (D3), macrogol 3350 (MIRALAX), multi vitamin, and ibuprofen (ADVIL DUAL). The patient previously took ciprofloxacin (CIPRO) and morphine: and had allergies with both drugs. The patient reported that on 11Mar2021, her heart was fluttering and beating it out of her chest with elevated heart rate which goes up and down. She also felt her heart was racing. It was very erratic. The highest heart rate was 130 (non-sustained). It was started since morning after the vaccination and was still happening now and wanted to know that it was a normal side effect. She had a cardiac work up and couldn't find anything however, everything was normal. Her heart rate went up to 130, 140, 150 and went to 80. This was happened over a period of 5 or 6 days. She felt like she could not do anything and was lying in bed or on the couch for three days. Her white blood cell count was higher that it should be. She went to her regular doctor who did the EKG, however, results not provided. Further, she went to a Cardiologist and they did another EKG and wore a monitor for a week and did echocardiogram and blood work all results were normal. She was wondering, if this could possibly be a side effect from the vaccine because it did occur in the morning after she got vaccinated. She also reported that she had allergies to medications but not what was in the vaccine and that maybe she had a reaction to the chemicals in the vaccine. She was supposed to get the second shot of vaccine which was scheduled on 31Mar2021 and had concerned about getting the second shot because she had some allergies and now this happened. She was very frightening and thought that she was going to die. It was very scary for her. The product complaint was not reported. The patient did not receive any treatment for the event. Outcome of the event Allergy to chemicals was unknown and for all other events it was recovered on an unknown date in Mar2021. No follow-up attempts possible. No further information expected.
62 2021-04-27 pain in extremity, tenderness Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee... Read more
Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.
62 2021-04-27 inability to speak I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got li... Read more
I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine.; she can't talk, it's closing up her throat,; she can't talk, it's closing up her throat,; taste sodium in my mouth constantly; coughing; got home and I've been sick ever since.; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration administered on right arm on 07Apr2021 at 13:30 (at the age of 62-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing Allergies with This was under control, ongoing asthma with This was under control, meniere's disease from 1989 and ongoing with This was under control, have 2 broken knees. Patient knows how to control this condition, she didn't need Prednisone prior to onset of these adverse events, Low immune system with She has an immune deficiency so her immune system very low, like 300., Respiratory illness, Genetic/chromosomal abnormalities, Endocrine abnormalities with endocrine abnormalities (including diabetes) and obesity. Family Medical History Relevant to AE reported as None. History of all previous immunization with the Pfizer vaccine considered as suspect reported as Both doses of product documented in Pfizer Suspect Vaccine and Vaccination fields. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207; Expiry date: 31Jul2021) via an unspecified route of administration to the right arm on 13Mar2021 at 13:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine other than dose 1 of 2 of the Pfizer-BioNTech Covid-19 Vaccine. Regarding concomitant products and other medical conditions patient reported none other than just her inhalers which doses of had to be increased in response to symptoms after first and second doses of Pfizer-BioNTech Covid-19 Vaccine. Concomitant medication included tiotropium bromide (SPIRIVA) taken as Dose increased to twice in the morning daily for an unspecified indication from an unspecified start date and ongoing, (Lot number: 0014678, ; Expiration Date: Jan20230); fluticasone propionate, salmeterol xinafoate (ADVAIR) 500 taken as Dose increased from once daily to twice daily an unspecified indication from an unspecified start date and ongoing; azelastine hydrochloride (Lot Number: 3N2E, Expiration Date: Feb2022), fluticasone propionate (DYMISTA) taken for an unspecified indication from an unspecified start date and ongoing (Lot number: GA00510, Expiration date: May2022); prednisone (PREDNISONE) taken for an unspecified indication with quantity of 27, Dose: 3-20mg daily for 7 days, then 2-20mg daily for 2 days, then 1-20mg daily for 3 days and Ongoing therapy. She also used a nose spray that didn't work so they switched her back to Dymista nose spray. Consumer stated that she received both doses of Pfizer's COVID vaccine and had reactions to both of them. Consumer stated that, "The second dose was even worse. They put her on Prednisone. She did not know if she should be tested again or not? She was sitting up but she could not walk around anywhere. She had 2 broken knees. She could not walk anywhere. After the second dose, they had to bring her to the hospital because she couldn't even walk to her car. She got home and she had been sick ever since. She had allergies too. She could not do anything. she had a hard time breathing. she was hesitant to get the 2nd one, but everybody said to get it. Her IgG level was down to 300 something. She was also tapering off of prednisone and she did not want to be tapering off it because it was worked well for her. She could tell by her breathing that it was helped her. She could taste sodium in her mouth constantly since she had got the vaccination." Second dose completed her prescribed therapy. Dates for Symptoms From 15Mar2021 to Ongoing Reported seriousness for Symptoms reported as Unspecified and the Symptoms was reported as worsened. Patient's doctor dropped her last week, told her she didn't know what to do with her, and that this was too stressful. Onset of symptoms following first dose of Pfizer-BioNTech Covid-19 Vaccine was on 17Mar2021. She couldn't breathe very well when she went in for the first dose of Pfizer-BioNTech Covid-19 Vaccine. She was ok the first day after the first dose of Pfizer-BioNTech Covid-19 Vaccine, seemed ok, arm didn't hurt; but then had onset of symptoms. She has been in bed the whole time since onset of symptoms, was in bed for over 2 weeks. She slept for 2 days straight, only got up for water and the bathroom. It was bad, getting hard to breathe. She had to use her emergency inhaler. The Pfizer-BioNTech Covid-19 Vaccine messed up her Meniere's disease. Doctor started patient on Prednisone for these symptoms, and Prednisone is really the only thing that clears up Meniere's disease because her ears was full and she could not get up. Prednisone helped her and I relayed in her 'rescue' inhalers (treatment) because she did 2 in the morning, two inhalers anyway when she started to feel better, she got her second one and it made her worst. She did not eat anything salty or anything, the barometric pressure was not bad. It was really funny because she had just finished everything and it was a few days before she had to go get her second dose of Pfizer-BioNTech Covid-19 Vaccine shot. She was just starting to feel normal, at least normal for her, she could get up normal and drive. They gave her the second shot of Pfizer-BioNTech and it was like a double. She clarified as she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tasting sodium in her mouth from the Pfizer-BioNTech Covid-19 Vaccine. She can't have much sodium which struck up the Meniere's disease really bad the second day after the second dose of the Pfizer-BioNTech Covid-19 Vaccine; her allergies in her head went bonkers. She could not talk, it was closing up her throat, she was coughing every time she eats or dinks, and she's having a "really bad" adverse reaction to the Pfizer COVID-19 vaccine after the second dose. They had to take her out of the hospital to her car in a wheelchair "right after" getting the second shot. She could not get more than 1000 mg of sodium a day, she tastes it in her mouth constantly, she could not get rid of it and it was "going through her system". She wanted to know what to do, since her doctor told her to contact Pfizer. She wanted to know what part of the vaccine is doing that, she assures it is sodium, because sodium is in her mouth 24/7 and she could not get it out, she could not have that much sodium in her body. It was still getting really hard to breathe. She is still taking the Prednisone she was initially prescribed and started on for the symptoms that started after her first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tapering off of Prednisone, and she shouldn't be tapering off, she thinks she needs to be Prednisone for some more days, maybe 3 more days, then she would be ok. It was prescribed as a 7-day burst of Prednisone. She mentioned that the only Prednisone that works on her is the Actavis manufactured Prednisone; her pharmacy orders it for her because they know that. She called the emergency room Saturday when she was really bad. They said they had a line there and it was going to be at least a 4 hour wait. With patient's low immune system, Meniere's disease and that she could hardly breathe she did not go to the emergency room because she could catch something and die while waiting. She decided she would just stay at home and rest. She has not had any Physician's office visit relative to event; she has a telephone appointment tomorrow to see if the doctor is going to be her doctor. She had to cancel her appointment with the doctor today because if she has something she doesn't want to spread it, she feels worse now and with the Meniere's she is tasting sodium in her mouth constantly from the Pfizer-BioNTech Covid-19 Vaccine, she does not eat a lot of salt. The flu shot takes her a couple of days, then she is right back up and Vaccination Last dose on Oct2020. Consumer stated that she has 'Meniere's' disease (History) and it made her worse. The patient underwent lab tests and procedures which included IgG level: 300. Reporter stated the seriousness for the events was Unspecified. Seriousness of event Meniere's disease aggravated was medically significant. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
63 2021-01-01 difficulty speaking Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively... Read more
Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively got worse and I felt throat swelling and my voice was effected. No itchy throat like my anaphylaxis reaction to shellfish only swelling. I mildly panicked and wanted to take Benadryl. About 1/2 hour later by the time I got home reaction was over. No repeat of symptoms ever again.
63 2021-01-04 pain in extremity 6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she start... Read more
6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she started to have abdominal pain which worsened over the course of the day to excruciating. She went to the Emergency Room where a CT scan revealed a perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening of 1/3/2021.
63 2021-01-05 numbness My right face, around the cheek/mouth area had a feeling like when you get Novacaine and lasted abou... Read more
My right face, around the cheek/mouth area had a feeling like when you get Novacaine and lasted about an hour.
63 2021-01-05 facial paralysis, numbness, tingling right mouth drop; right face numbness from eyebrow to below chin with right mouth drop; pins and nee... Read more
right mouth drop; right face numbness from eyebrow to below chin with right mouth drop; pins and needles feeling at injection site; then ears itching; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via an unspecified route of administration, on 30Dec2020 at 03:45 AM (at the age of 63-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the right arm. Medical history included: History of Guillain Barre in 1970's with Swine Flu Vaccine. Concomitant medications included: clonidine (MANUFACTURER UNKNOWN), hydralazine ((MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took unspecified medications (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced sensitivity to some medications, and unknown if ongoing. On 31Dec2020 04:15 PM, the patient reported "Within 30 minutes of vaccine, I had pins & needle feeling at injection site. Then ears itching followed by right face numbness from eyebrow to below chin with right mouth drop." The patient did not receive any treatment for the events. The clinical outcome of the events pins & needle feeling at injection site, ears itching followed by right face numbness from eyebrow to below chin with right mouth drop, was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the temporal association.
63 2021-01-06 tingling Headache tingling hands and lips, tongue felt thick/swollen Narrative: 12/30 given vaccine in the E... Read more
Headache tingling hands and lips, tongue felt thick/swollen Narrative: 12/30 given vaccine in the ED due to a shellfish allergy for which she carries an epipen. Pt experienced mild symptoms c/w allergic reaction after receiving Pfizer COVID vaccine #1. Symptoms included tingling lips and sensation of swollen tongue. She was given Diphenhydramine 50mg PO. Condition did not progress and her symptoms resolved within about one hour of oral Diphenhydramine. She was observed for 3 hours and discharged to home with prescriptions for an epipen and benadryl. Employee states - "15 min after the vaccination my hands got tingly on the palms. 5-10 min after that the front of my lips were tingly then my tongue felt thick. I also got a headache They gave me benadryl pills in the ED and within 10 min tingling on my lips went away and my tongue felt normal. My headache also went away." She was discharged from the ED back to work and reports no other symptoms.
63 2021-01-06 night sweats Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, c... Read more
Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency. Tested + for COVID on 1/4/21 Narrative: Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency, sees hematology. Currently taking prn tylenol, scheduled to see hematology. Tested positive for COVID on 1/4/21.
63 2021-01-06 muscle spasms This is a self report: two days after the vaccine I developed severe heart burn ( something I have ... Read more
This is a self report: two days after the vaccine I developed severe heart burn ( something I have never experienced). Several over the counter medication were used without relief. . The heart burn was followed by a horrible gastric disturbance. I experienced abdominal pain, cramping and rectal pain. During this time my temperature remand between 100.0 - 101.0 with fatigue and malaise. I have also noticed several welts on my body. I?m typically a very health person and have never experienced any of these experiences before.
63 2021-01-07 tingling Patient experienced paresthesia in the face from the eyebrow down to the chin within a few hours aft... Read more
Patient experienced paresthesia in the face from the eyebrow down to the chin within a few hours after the first dose of the Pfizer COVID-19 vaccine. Aside from the paresthesia under the eye that lasted approximately 48 hours, the remainder of this effect slowly improved within hours. The patient has no contributing medical conditions, chronic or short-term medication use, or drug allergies.
63 2021-01-07 pain in extremity Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the i... Read more
Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the injection arm; Her arm was stiff feeling; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), intramuscular on 18Dec2020 15:00 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The transferring agent stated that she has a caller on the line that received the first dose of the Covid-19 vaccine on 18Dec2020. She is supposed to get the second dose tomorrow 06Jan2021. She developed a urinary tract infection over new years and was put on antibiotics. She wanted to know if she could get the second dose while on antibiotics. The transferring agent stated that the caller reported that she started feeling achy and had a headache, but did not think it was related to the shot. She stated that she had injection site pain and was sore on the injection arm. She had the shot late in the afternoon around 15:00 on 18Dec2020. She said that she was sore later on that evening at the injection site and her arm was stiff feeling the next day, but it was resolved by the day after. She said that the headache came and went. She treated it with Tylenol. She said that she did not feel real good most of the day on Saturday 19Dec2020, but by Sunday she was back to normal again. The outcome of the event Urinary tract infection was unknown while the outcome of the other events was resolved on 20Dec2020.
63 2021-01-07 pain in extremity heart rate in the 120's which last 15 minutes while at rest; Left arm deep aching; This is a spontan... Read more
heart rate in the 120's which last 15 minutes while at rest; Left arm deep aching; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in the left arm on 30Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included pulmonary embolism (PE's x 2) and left nephrectomy for kidney cancer (CA). Concomitant medications included apixaban (ELIQUIS), losartan and hctz. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020 18:00, the patient experienced heart rate in the 120's which lasted 15 minutes while at rest and left arm deep aching for 2 days. Outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
63 2021-01-08 pain in extremity Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki... Read more
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. I am awaiting an appointment with my primary care physician and will know then if more treatment will be recommended. Incident Report filed at the hospital.
63 2021-01-09 tremor I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey. I hav... Read more
I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey. I have had these symptoms for 12 days, unchanged. I cannot work because of these symptoms. I have been to urgent care and have had lab work and an EKG
63 2021-01-09 pain in extremity Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slight... Read more
Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slightly red. Sunday morning, she could not put any weight on right foot, more red/all toes red (except one), redness is traveling down right big toe, right foot appears slightly swollen.
63 2021-01-10 weakness Extreme fatigue/weakness body aches, especially hips
63 2021-01-10 tremor severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is ... Read more
severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is - should I get the #2 dose in light of the robust antibody response to #1. Could it be even worse?? Any information on this?
63 2021-01-10 weakness weakness, fever, cough
63 2021-01-11 weakness I felt ok right after the injection but about 2 hours later I started experiencing a pressure headac... Read more
I felt ok right after the injection but about 2 hours later I started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking I felt ok but after walk; weakness; felt very poorly; This is a spontaneous report from a contactable other health care professional. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL1284), intramuscular on 04Jan2021 11:45 at single dose at left arm for COVID-19 immunization. Medical history included hypothyroidism, psoriasis. Concomitant medications included etanercept (ENBREL), and levothyroxine. The patient felt okay right after the injection but about 2 hours later, on 04Jan2021 14:30, she started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking the patient felt okay but after walking around the house for about 20 minutes, the headache started up again and the same awful feeling of weakness so she laid down and took another 2 hours nap. When the patient woke up the second time she felt as though nothing had happened, was feeling fine. So the patient would say the side effects lasted for about 5 hours. The outcome of the events was recovered on 04Jan2021 17:00.
63 2021-01-11 pain in extremity Sore right arm; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old fe... Read more
Sore right arm; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK 9231, via an unspecified route of administration in the right arm on 31Dec2020 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history included hypothyroidism, hypertension, high cholesterol, penicillin allergy; all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan, levothyroxine/liothyronine (NP THYROID), simvastatin, vitamin B, vitamin c [ascorbic acid], colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 01Jan2021 at 12:00, the patient experienced a sore right arm. Treatment was not received for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the sore right arm was resolved on Jan2021.
63 2021-01-12 tremor Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors ... Read more
Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors to all extremities (for about 10 mins) and chills the night after getting the vaccine. tongue numbness happens to her at baseline at times, this has subsided The tremors started after stretching her arms, they stopped shaking after about 10 mins after she laid in bed. Temp was about 100-101.2 through the night Has not taken any medications for this.
63 2021-01-12 one side paralysis She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face ... Read more
She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face weakness. She did recover fully. She already has known CAD and risk factors for CVD. It is possible, but by no means certain, that the vaccine was an indirect cause of the event. Since the vaccine provoked an immune response, as it was supposed to, it is possible that this inflammation may have set up a metabolic predisposition that may have contributed to the event, which was 12 days later.
63 2021-01-12 pain in extremity horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat;... Read more
horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-01-12 pain in extremity, muscle spasms temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both leg... Read more
temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both legs; aching all over and headache and body aches ; fatigue and extreme muscle tenderness in left arm (site of injection) Temp remained at above 100.0 even with Tylenol and headache and body aches until 9:00pm. Woke up on 1/13/2021 with only symptoms being sore arm; slight headache and muscle tightness in neck.
63 2021-01-13 pain in extremity Developed DVT in left leg around January 9. Developed pain, redness and swelling in left calf
63 2021-01-14 facial paralysis Bells Palsy 1st injection on 12/20/21 symptoms started 1/7/21, 2nd dose on 1/10/21 immediate numbne... Read more
Bells Palsy 1st injection on 12/20/21 symptoms started 1/7/21, 2nd dose on 1/10/21 immediate numbness in mouth and tightness in throat which triggered bells palsy symptoms immediately
63 2021-01-14 weakness Fever, chills, headache, body aches, nausea, generalized weakness
63 2021-01-14 pain in extremity Left arm severe pain, swelling, redness, and hot to touch
63 2021-01-14 tingling, numbness numbness tingling in both arms into hands
63 2021-01-17 pain in extremity Severe chest pain ( like a vice was tightening around chest). Lasted 20-25 minutes. No nausea. Had... Read more
Severe chest pain ( like a vice was tightening around chest). Lasted 20-25 minutes. No nausea. Had to go to ER, Labs all negative, could find no reason for pain. Went home after approximately 3-4 hours in ER. Also arm pain x 1 month now
63 2021-01-18 feeling cold 10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10)... Read more
10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10). BP - 172/85mmHg; Pulse - 94). 10:18am - BP - 176/93mmHg; Pulse - 104 10:20am - BP - 186/93mmHg; Pulse - 105, client reports the pain and nausea symptoms are the same. Client taken to an exam room and placed lying down on her left side, head slightly elevated. Client reported feeling a bit cold, covered with disposable gowns for warmth. Temperature taken at 10:34am - Temperature: 37 degrees Celsius. 10:43am - BP 130/60mmHg, Pulse - 92. Client reported that feelings of nausea is gone, however is still experiencing slight headache 4/10 pain scale. 10:57am - BP 124/64mmHg; Pulse - 88 10:59am - BP 174/89mmHg; Pulse - 99. Client reports that she feels a sharp pain on her abdominal area by the belly button (6/10). Also reports a mid-back pain (9/10 pain scale). 11:10am - BP 162/86mmHg; Pulse - 101 11:15am - BP 147/78mmHg; Pulse - 89. Client reports abdominal pain at 5/10, mid-back pain 8/10. 11:25am - BP 155/82mmHg; Pulse - 90. Client reports abdominal pain is aching at 5/10 pain scale, mid-back pain 7/10 pain scale.
63 2021-01-18 weakness 12/29 vaccine 10:45. Twenty minutes after vaccination, breathing fast, stiffness in L neck. L sided ... Read more
12/29 vaccine 10:45. Twenty minutes after vaccination, breathing fast, stiffness in L neck. L sided weakness; transported to ER. I couldn't lift left leg, 1" off bed and couldn't do the push pull. 1-2 hours symptoms lasted. Everything went back to normal, sent home. 12/30 huge flare up with fibromyalgia; lasted couple days. Flare up occurred the following week. Getting second shot 1/19/2021
63 2021-01-18 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable consumer. A 63-years-old female patien... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: ELD14D, via an unspecified route of administration, in left side of arm, on 04Jan2021 at single dose for COVID-19 immunization. Medical history included early breast cancer from 2017 and ongoing. Concomitant medication included tamoxifen citrate 20 mg tablet by mouth once daily from 2017 and ongoing for breast cancer (cancer pill, she has to be on it for 5 years). The patient received the vaccine as she is "with fire department, thought she needed to take it, she had early breast cancer, is around lots of people". On 09Jan2021 the patient was diagnosed with Bell's palsy, assessed as medically significant and in Jan2021 she experienced earache (she thought it was an earache, but it was more than that, but it made her ear hurt, and she has no infection), her mouth was drawled a little, further detailed as numbness and "the eye, it is messing with it, when she is trying to see out of it, she can see, but it's blurry like" and, "where the ear thing is", on the back of the lymph node was real sore and her face was kind of puffy, which is the reason she went to the doctor. The patient had to go to her doctor, he told her she had a reaction to the shot, he called it Bell's Palsy, and said to let Pfizer know. Her doctor gave her something to take for mouth drawled/numbness, which is supposed to help, and she has to go back in a week. The event Bell's palsy outcome was unknown at the time of the report.
63 2021-01-18 tingling Bottom lip tingling and both hands tingling
63 2021-01-18 weakness, pain in extremity Injection was administered very high on left arm(at joint level). It felt like a nail went in, and t... Read more
Injection was administered very high on left arm(at joint level). It felt like a nail went in, and then she pushed in the medicine. Just the injection process alone made me feel ill. So I waited the 15 minutes before I left, until I felt safe to drive. At noon the meds started affecting me, which is what I expected. I've continued to experience arm pain, weakness, armpit swelling and tenderness, arm not wanting to work and posturing. This is day four and its just starting to feel like its coming back "online." Monday I reported to Colleague Health, who advised me to contact my physician, who I consulted via phone this morning. Physician requested I fill out Adverse Event form.
63 2021-01-18 tingling Pt had heavy feeling in her feet followed by a choking feeling in her throat. Also noted tingling in... Read more
Pt had heavy feeling in her feet followed by a choking feeling in her throat. Also noted tingling in hands and feet.
63 2021-01-18 flushing Systemic: Nausea-Medium, Systemic: Flushing-Medium
63 2021-01-18 cold extremities from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade f... Read more
from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade fever (99 degrees) treatment taken at 0515 am --1 dramamine, 2 tylenol 0800 am- headache, temp 98.3 0915 am- headache treatment- 1 advil pm 0815 pm- temp 99, chills treatment- tylenol 3 days post vaccine- headache, nausea (treatment advil pm, dramamine) 6 days post vaccine- headache, nausea (treatment advil pm, dramamine) 9 days post vaccine--headache, nausea (treatment advil pm, dramamine)
63 2021-01-19 pain in extremity 12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,hea... Read more
12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,headache,body aches,very sore arm 36 hrs after vaccine swollen lymph nodes under rt arm, temp 99.8
63 2021-01-19 tingling Patient monitored for 15 min after her 2nd dose of vaccine and she experienced no symptoms before le... Read more
Patient monitored for 15 min after her 2nd dose of vaccine and she experienced no symptoms before leaving the clinic. She returned 2 hours later with anxiety, hyperventilation and paresthesia. Vital signs showed improvement before symptoms resolved.
63 2021-01-19 pain in extremity, feeling hot felt warm, slight fever, headache, very sore arm. Dizzy.
63 2021-01-20 facial paralysis Bells Palsy; This is a spontaneous report from a contactable Other HCP (patient). A 63-year-old fe... Read more
Bells Palsy; This is a spontaneous report from a contactable Other HCP (patient). A 63-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL1284) intramuscular at single dose at left arm on 29Dec2020 16:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, thyroid disorder, high cholesterol, fibromyalgia, allergy to sulfur drugs and codeine. The patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. The patient previously took codeine and experienced drug hypersensitivity. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced bells palsy on 11Jan2021. The event resulted in Emergency room/department or urgent care. The event bells palsy has been treated with steroids. Post vaccination, the patient has been not tested for COVID-19. The outcome of event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bells palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
63 2021-01-20 feeling cold Pain at injection site, headache, chills muscle aches, joint pain, restless
63 2021-01-20 flushing Patient experienced "flushing" after receiving her Dose 2. Symptoms resolved within 15 minutes.
63 2021-01-20 pain in extremity The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection w... Read more
The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection was light red, warm to touch and painful. The area was approximately 2.5 inches around. On Sunday 1/10 it was bright red, indurated, hot to the touch and much more painful. It was also painful to move his arm. On 1/13, the injection site was still tender to the touch and his shoulder area was sore with movement. Over the next couple of days his shoulder into his bicep had a dull ache and was very painful to any pushing, pulling or weight bearing. Ibuprofen did help but did not relieve it. On 1/17 patient went to a local urgent care because at that point it was even difficult to sleep due to pain. They diagnosed him with bursitis of the left shoulder due to SIRVA. He was started on a steroid pack and today, day 2 of steroids it feels slightly less painful.
63 2021-01-20 muscle spasms, tingling severe cramps/bunch of spasms with legs and arms; quick stools; Wake up probably about an hour, hour... Read more
severe cramps/bunch of spasms with legs and arms; quick stools; Wake up probably about an hour, hour and a half then I still feel tired I ended up going back to sleep for another 4 hours; almost like pin pricking; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included blood pressure, thyroid disorder and hormone level abnormal. Previous vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation, with no side effects. The concomitant medications was reported Levothyroxine at 5 ug 1x/day for thyroid; atenolol, chlorthalidone (ATENOLOL AND CHLORTHALIDONE) 50/ 25 for Blood pressure; estradiol (ESTRACE) at once a day For hormones. blood pressure management. Patient had second shot on Friday (08Jan2021), she was fine until about 09Jan2021 2:30 in the morning then patient woke up with severe cramps and quick stools, she had about 4 dumps throughout the day she was trying to work and then by 4:30, 5 O'clock patient was having enough drinking water and a whole lot of fluids, stools along with a lot of severe cramping, so she ended up calling in today for work which was definitely not her. Then patient went ahead and she have slept 'many parts of today' (not clarified), she slept like, wake up probably about an hour, hour and a half then she still feel tired ended up going back to sleep for another 4 hours. Patient worked only 3, 3 and a half hours a day because of her health, she had 7 or 8 round so don't normally sleep long but she was healthy. 'Problem is' (voice feeble), now that patient had gotten herself a little more relaxed patient was having a bunch of spasms with legs and arms and almost like pin pricking, so said just to call and let you know she tried but couldn't do it online." Treatment was received for events, took the Tylenol 500 (unit not probed) 1 tablet, took that at 4 O'clock.. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
63 2021-01-21 pain in extremity Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, cou... Read more
Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, couldn?t get warm. Got worse during the night. Couldn?t go to work the next day due to body aches, arm soreness, extreme tiredness. Slept almost all day 1-19-21. Spiked low grade fever during the night. Worked 1-20-21, but extremely sleepy. Injection site got hot and red. Slept 12 hours that night. Went to work 1-21-21 feeling good, just still a little arm soreness.
63 2021-01-21 feeling cold Chills, diarrhea. Improved.
63 2021-01-21 feeling hot I was okay during the 30 minute observation period, and was discharged. Between 1 and 1:30 am, abou... Read more
I was okay during the 30 minute observation period, and was discharged. Between 1 and 1:30 am, about 15 hours after receiving the vaccine, I woke up from my sleep suddenly, with an acute episode of chest tightness, cough, severe running nose and lacrimation. I did not have hives or lip/throat itching or swelling. I felt a little warm in the face. I took Ventolin inhaler two puffs twice 30 minutes apart + Aller-flo nasal sprays. I began to feel a bit better and then took Benadryl 25 mgms (because of my history of Angioedema) around 2:30 am. I feel better now, which is 12 hours after onset of episode, but had to take Ventolin inhaler this morning for a bit of chest tightness. I do not have a history of asthma, but have had seasonal allergies in past years. But if this is seasonal allergy, it is very unusual, since I have never had an acute episode like this without any early milder symptoms. And I haven't needed Ventolin in a couple of years. I am now concerned about taking the second dose.
63 2021-01-21 pain in extremity pt. experiencing arm pain, vomiting, shortness of breath, dizziness
63 2021-01-22 hot flush Throat and back of tongue swelling, hot flushes in head and face. High blood pressure and pulse.
63 2021-01-23 pain in extremity Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki... Read more
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. Incident Report filed at the hospital. MRI done on 1/20/2021-saw Doctor on 1/22/2021 who diagnosed adhesive capsulitis.
63 2021-01-24 pain in extremity Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extr... Read more
Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extreme pain lasted from 0140- 0500, but continued with the skin tenderness, chills, headache and joint pain. Took Tylenol. Got up once and thought I would pass out. Started resting some around 7am. Drank plenty of fluids. Drained all day. Saturday morning headache, nasal congestion, joint pain, hard to get out of bed. Drained all day. Sunday feeling better, but lethargic. Monday back to work.
63 2021-01-24 weakness Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, s... Read more
Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.
63 2021-01-24 pain in extremity lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle cap... Read more
lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle capacity; headache; terrible pain in her right elbow; joint discomfort; feeling achy in her right arm and all over; feeling achy in her right arm and all over; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), via an unspecified route of administration on 06Jan2021 14:30 at single dose for covid-19 immunisation. Medical history included hypothyroidism, cholesterol. Concomitant medication included levothyroxine, atorvastatin. Patient on the line calling about the COVID 19 Vaccine on Wednesday in her right arm. Her right arm lost muscle capacity, she cannot lift, she cannot even lift a gallon of milk in the fridge. This has improved, but she still cannot use it normally. Thursday she was feeling achy; Friday she had a headache. Later that day she had the most terrible pain in her right elbow. It was excruciating pain. The next morning pain subsided. However, she does not have her full arm strength back yet. She confirmed she is a HCP. She also added, she works at the hospital. It is like a centralized monitoring system where she watches monitors connected to the care unit and since she has background as a HCP she alerts the nurses when there is an issue. She clarified her right arm lost muscle capacity was noticed on Friday 08Jan2021. She got the vaccine on 06Jan2021 and was able to drive home and it was fine. The next day, 07Jan2021 she was achy, like flu like, with joint discomfort that she normally does not have even though she is getting older. She was feeling achy in her right arm and all over. The achiness all over resolved Thursday or Friday. She confirmed she has recovered completely. On Friday 08Jan2021 she had a headache that would just not go away. The headache was not in the front, back, or above eyes so she knows it was not sinuses. The headache lasted all day. Stated by the next morning the headache was gone. Her head is fine. She confirmed she has recovered completely. She later added, even though she is getting older and forgets things. No additional details provided. She was supposed to go to work on Friday, but she was not quite miserable, but she just could not bring herself to go into work. She called out because of the headache and the arm pain had started to kick in. The outcome of the event Muscle weakness upper limb was resolving, joint discomfort was unknown, while the outcome of the other events was resolved in Jan2021.
63 2021-01-24 pain in extremity right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, ... Read more
right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, also left hand swelled, with rash and itching. Next day woke up with sore throat and headache, and fatigue. went to primary care doctor was put on prednisone, symptoms lasted for 10 days.
63 2021-01-25 muscle spasms Diarrhea and abdominal cramping 1 hour after second dose of Covid vaccine. Took OTC medication, Imod... Read more
Diarrhea and abdominal cramping 1 hour after second dose of Covid vaccine. Took OTC medication, Imodium, motrin, soft bland diet. Six + episodes of diarrhea in one hour on 1/21/2021 with significant cramping. Went to ER. Received fluids and IV Zofran. CBC and CMP WNL. Stool test also done--negative. Discharged. Severe diarrhea morning of 1/22/2021. Missed work on 1/21 and 1/22. Diarrhea and abdominal cramping continued intermittently. Worked Monday. Stool samples provided. C.Diff negative. Lactoferrin positive. Enteric bacterial panel negative. CT of abdomen scheduled for 1/27/2021
63 2021-01-25 pain in extremity Sore arm, dizziness, nausea , lightheaded
63 2021-01-25 migraine Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days... Read more
Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days; Migraine headache on day 6.; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 30Dec2020 at 11:00 A.M., at a single dose, for COVID-19 immunization. Relevant medical history included high blood pressure (BP), seasonal allergies, migraine, asthma, right sided hearing loss. The patient was taking unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 01Jan2021, at 8:00 A.M., the patient experienced soreness at injection site for 72 hours. On day 3, the patient had low grade fever 99.6. On an unspecified date in Jan2021, the patient had gastrointestinal (GI) upset for 3 days. On day 6, the patient experienced migraine headache. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
63 2021-01-25 pain in extremity headache, body ache, chills, fatigue, sore arm, Nausea
63 2021-01-26 difficulty speaking : 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning... Read more
: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning neck with stiffness . 2nd day Chills, headache. Joints are in pain along with other body pain, nausea. Now, fever 99.1. 3rd day is today, 01.27.21, voice is affected, fatigued body is very achy.
63 2021-01-26 tremor Sudden onset of chills and shakes for about 6 hours, headache, stomach distress, muscle aches,
63 2021-01-27 discomfort Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been ... Read more
Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been experiencing extreme fatigue. On Sat. around 5:00 PM she was standing at her flat-top stove cooking dinner. A wave of very extreme fatigue came over her, so she leaned over to turn off the burner. When she did this, she passed out leaning forward with her hand on the burner and touching the frying pan. When she came to, she went to the couch and laid down - not realizing for 10 minutes that her hand and right breast were burned. The resulting injuries lead to her having to see her PCP on Monday, and then a General Surgeon on Weds 1/27/21. Injuries sustained include a second degree burn on her right breast, On the right arm, laterally above the wrist is a small superficial partially healed burn. On the dorsal aspect of the right fifth finger there is a longitudinal burn that goes from the MCP joint to almost the tip of the finger. She has limited range of motion due to discomfort and swelling. The blister encompasses the entire dorsal lateral aspect of the finger. The fourth right finger has a less extensive blistered area on the PIP joint. The burn on the fifth finger is deep second degree.
63 2021-01-27 pain in extremity fever, nausea, vomiting, severe body aches severe left arm pain, all symptoms worse that 1st dose. F... Read more
fever, nausea, vomiting, severe body aches severe left arm pain, all symptoms worse that 1st dose. Fever persisted from 1/7/21 to 1/10/21. Seen in ER 1/9/21 with T 101.9 again & workup (-) for bacterial infection /sepsis , COVID neg, flu neg.
63 2021-01-28 feeling hot, numbness, tingling 8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest... Read more
8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-01-28 pain in extremity, weakness Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle ac... Read more
Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle aches and weakness, joint pain, severe head ache, nausea, extreme fatigue and slight confusion. Started about 11 hourse post injection and symptoms lasted 20 hours. Acetaminophen and increased water intake. Intermittent bedrest. Missed a day of work. Then suddenly everything cleared and I was wide awake and clear headed, just a little weak in muscles.
63 2021-01-29 numbness, tingling 10 hours after my vaccine I got a rush of heat to my feet...felt like they were swelling. Tingling &... Read more
10 hours after my vaccine I got a rush of heat to my feet...felt like they were swelling. Tingling & numbness followed & also went to my hands. 9 days later I still have some residual tingling, mostly in my feet.
63 2021-01-29 feeling cold Late evening after shot felt like was getting a cold, runny nose, tired. Next day had fever, high o... Read more
Late evening after shot felt like was getting a cold, runny nose, tired. Next day had fever, high of 100.0 F, joint pain, headache, fatigue. Lasted about 24 hours, improved by second day after shot with minor fatigue for another day, by 3rd day felt normal.
63 2021-01-29 flushing The employee received 1st dose of Pfizer Covid-19 vaccine at 14:00 pm 1/28/2021. About 5 minutes af... Read more
The employee received 1st dose of Pfizer Covid-19 vaccine at 14:00 pm 1/28/2021. About 5 minutes after receiving the injection, she felt itchiness of the ears, facial flushing and developed neck hives. She was taken to the MSB emergency room, where she was closely monitored. There, she was given dexamethasone 6 mg IM once, diphenhydramine 50 mg orally and famotidine 20 mg orally once. After about 2 hours of observation, he was discharged home on the following: prednisone 40 mg orally daily and diphenhydramine 25 mg q8h PRN.
63 2021-01-31 difficulty speaking Hoarseness for 3 hrs in the morning.
63 2021-01-31 pain in extremity Sore arm at injection site; Sore arm at injection site; This is a spontaneous report from a contacta... Read more
Sore arm at injection site; Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL1284), via an unspecified route of administration in the left arm on 13Jan2021 at 18:30 as a single dose for COVID-19 immunization. Medical history included Sjogren's Syndrome, connective tissue disorder, high blood pressure, was pre-diabetic, and had a known allergy to penicillin. The patient had other medications in two weeks (unspecified). The patient was not pregnant, had no other vaccines in four weeks, and did not have COVID prior to the vaccination. The patient experienced sore arm at injection site on 13Jan2021 at 21:00. The patient did not receive any treatment for the events. She was not COVID tested post-vaccination. Outcome of the event was recovered.
63 2021-01-31 weakness The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions... Read more
The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On 01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.
63 2021-01-31 tremor, weakness itching 3-4 days tremors, weakness
63 2021-02-03 pain in extremity, feeling hot 1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,... Read more
1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,nausea,chills 4th day - headache, chills and feeling hot, nausea,skin rash , itching, tired,aches 5th day - headache,chills and feeling hot, nausea,rash and uncontrollable itching, tired.
63 2021-02-03 pain in extremity Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperatu... Read more
Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperature is usually 97; Arm was extremely painful; Joint pain; Headache; Could not work today because I was not feeling good; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot), via an unspecified route of administration, on 13Jan2021 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history includes heart disorder. Concomitant medication included: Simvastatin, Atenolol, and medicine for my "heart". The patient reported that she received the first dose on 23Dec2021 and stated she had no reaction. On an unspecified date, the patient stated "I could not work today because I was not feeling good from the vaccine. I got it on the 13th I had off some work yesterday so I had a temperature aches and pains, fatigue and I had to call out last night. Today I am running still very slight fever, aches and pains - so it is improving." The first day, I was fine. I got it at the end of the day. The second day my arm was not red or anything but it was extremely painful, joint pain, headache, fatigue and my temperature was 99 (my temperature is usually 97). Today the temperature is lower and that does not hurt as much." The clinical outcome of the events malaise, aches and pain, fatigue, pyrexia, pain in arm, joint pain, and headache was unknown. No follow-up attempts are possible. No further information is expected.
63 2021-02-03 numbness Numb feeling from head all the way to nose; Headache; This is a spontaneous report from a contactabl... Read more
Numb feeling from head all the way to nose; Headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration, injection in upper left arm, on 20Jan2021 at 10:45 at single dose for COVID-19 immunization; administered in a clinic, like the county clinic. The patient's medical history included ongoing over weight (stated she is 100 pounds over weight), ongoing slight heart disease, ongoing thyroid issue, ongoing blood pressure, and feeling like claustrophobic with the mask. The patient previously received swine flu shot in 1976 and experienced odd headache, and received flu shot two months ago (Nov2020). She mentioned that in 1976 she was in the military and had the Swine Flu Shot. The president made it mandatory they get it because they were afraid there was going to be an attack and they all had to get this vaccine. After getting this vaccine she had an odd headache. She also had a headache after getting the COVID 19 Vaccine, but it was not as bad. She had a little headache with the numbness after she got the COVID 19 Vaccine. While in the military when she got the Swine Flu shot they administered it with an air gun. She does not have any details to provide a lot/exp/NDC. They were just hurrying up to administer because afraid of possible biologic attack. She mentioned a lot of people have had bad reactions to the swine flu shot, but no additional details provided. Concomitant medication included metoprolol and ongoing lisinopril; both for blood pressure. There were no additional vaccines administered on same date of BNT162B2, and there were no prior vaccinations within 4 weeks. The patient experienced numb feeling from head all the way to nose on 20Jan2021 10:46, and headache on 20Jan2021. The patient called to report minor adverse reactions that occurred after getting the vaccine. She did not want her HCP contacted because she wants to ensure she gets the second shot. She clarified the reaction was odd. She had her face mask on when she got the shot. Normally she has the feeling like claustrophobic with the mask on which also occurred after she got the shot. After she got the vaccine, she also started to feel numb from her head all the way to her nose. It lasted 45 minutes. She started to feel this numb feeling 1 minute after getting the vaccine. She could tell something was not right. She thought at first it was the face mask, but after she took the mask off after waiting the 15 minutes under observation, she still had the numb feeling as it had not gone away yet. She could touch her face and could feel the numb feeling. The numb feeling was like getting a tooth filled, not that bad, but something like that. The outcome of the event numb feeling from head all the way to nose was recovered on 20Jan2021 at 11:31, and the outcome of the event headache was unknown. She mentioned she has some friends who have passed away from COVID and who were hospitalized from COVID. That is why she is so grateful for the vaccine and putting it out there.
63 2021-02-03 feeling cold delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get... Read more
delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get warm even with multiple blankets; severe body aches; severe headache; fever of 101; nausea; thirsty; Symptoms began to abate today (almost 48 hours later) but still fet some foggy thinking; This is a spontaneous report from a contactable other health care professional (patient) and a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELIZ83), via an unspecified route of administration at arm left on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at arm left on 29Dec2020 at 9:30 at single dose for COVID-19 immunization. On Jan2021, the patient reported that 15 hours after second dose, he experienced extreme chills, so cold that it felt like burning ice cubes on his skin, he couldn't get warm even with multiple blankets, severe body aches, fever of 101 F, severe headache, delirious dreams, nausea, thirsty and feel some foggy thinking. The patient outcome of the event was recovering.
63 2021-02-03 discomfort muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a ... Read more
muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a spontaneous report via a Pfizer-sponsored program from a contactable nurse (reporting for herself). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), intramuscular in the left arm on 02Jan2021 at a single dose for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. The patient previously received the flu vaccine on unspecified date and experienced discomfort. On 02Jan2021, the patient experienced pain at injection site. On 03Jan2021, the patient experienced muscle aches and discomfort. The patient was scheduled for the second dose of the COVID-19 vaccine and reported that she took Aleve after she got the first vaccine and was wondering if she can take Aleve after the second one. She stated that it helped with the pain. She said that she was getting conflicting information and stated that she heard that there have been more symptoms associated with the second vaccine. She wanted to know if it was contraindicated for her to take the Aleve after getting the second dose. The patient described it as discomfort and stated that she gets it with the flu vaccine too. Aleve helped with the discomfort and the ache. She did not pre-medicate. She took it afterward. She stated that she took maybe 1-2 doses of the Aleve the next day and stated that by the end of the next day her pain was fine. The patient clarified pain was at the injection site and was achy. She said that she received the first vaccine on 02Jan2021 in the morning. She noticed the pain later in the day around midafternoon and said that it was gone by the next day. The outcome of the event pain at injection site was recovered on 03Jan2021 while outcome of muscle aches and discomfort was recovered on unspecified date in Jan2021.
63 2021-02-05 pain in extremity Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hour... Read more
Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hours I began to notice itching. My back, neck, legs, arms. Begins once my zyrtec wears off around 7:30 pm I always take and antihistamine to keep my nose clear for better sleep. All nighttime meds are take at 8- 8:30 pm. Must take ativan to control anxiety and help get to sleep
63 2021-02-07 feeling hot My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under... Read more
My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under my neck on the left side and then it traveled to the tight side of my neck/ had hives on my arms legs neck chest and back; within 5 more minutes my neck was red / my face started getting red; This is a spontaneous report from a contactable Health Professional, the patient. A 63-year-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3242), via intramuscular route in the left arm on 22Jan2021 17:00 (at the age of 63-years) as a single dose for COVID-19 immunization. Medical history included Thyroid -Hashimoto's thyroiditis, Penicillin allergy, Brussels sprouts and avocados allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine and ibuprofen (ADVIL). The patient previously took erythromycin and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 22Jan2021 at 17:15, after approximately 10 minutes of receiving vaccination, the patient started feeling warm, she noticed her arms were looking mottled and she went to the nurse. She first got hives under her neck on the left side and then it traveled to the tight side of my neck. Within 5 more minutes her neck was red, and her face had started feeling very hot. Her face started getting red. The patient was taken to the emergency room and she had hives on her arms, legs, neck, chest, and back. The patient was treated for feeling very hot, arms mottled, hives, and neck and face red with intravenous (IV) Benadryl 50mg with Famotidine IV and saline solution IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event for feeling very hot, arms mottled, hives, and neck and face red were recovered in Jan2021; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events is possible . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-02-08 night sweats, tingling Experienced severe cold chills whereas my body felt like pins and needles all over including body ac... Read more
Experienced severe cold chills whereas my body felt like pins and needles all over including body aches and fatigue. Woke up with night gown damp, so I probably had a low grade fever.
63 2021-02-09 burning sensation Got like the burning sensation too; This is a spontaneous report from a contactable consumer. A 63-y... Read more
Got like the burning sensation too; This is a spontaneous report from a contactable consumer. A 63-year-old female patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3249) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization, menthol, zinc oxide (CALMOSEPTINE [MENTHOL;ZINC OXIDE]), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication. Medical history included hiatus hernia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated, "I just put some Calmoseptine on it. It is over the counter, it is almost like a diaper rash that I used on it. But I kind of got like the burning sensation too." The outcome of the event was unknown.
63 2021-02-09 feeling cold Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up... Read more
Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up half the night; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: F19262), via an unspecified route of administration at her arm on 23Jan2021 at 0.3 mg (as reported) single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that that she and her 94 year old mother got the COVID-19 vaccine at a drive thru, and her mother did great. After the vaccine she had muscle aches, chills, fever, and was cold. She had side effects that lasted 30 hours, starting that night. She was chilling so bad, she would like to know if they think it was safe for her to get the second dose of the vaccine, they said it was worse for the second. She said she could not hardly work she was so sick after the first dose. She stated that she was really cold, and really sick, and all day, she just could not sleep all night, she was up half the night because she was so cold and just feeling sick. She had joint pain, she had it all. She started taking Aleve on Sunday and she started to get better. The night after she got the vaccine she got her heater and was sitting beside it. She felt tired the whole next day. Her symptoms came quicker than that, she took the Aleve the next day. The outcome of events muscle aches, chills, fever, joint ache was recovered. The outcome of other events was unknown.
63 2021-02-09 burning sensation burning sensation; severe blistering raised rash on right leg, arm, buttcheek and back; severe blist... Read more
burning sensation; severe blistering raised rash on right leg, arm, buttcheek and back; severe blistering raised rash on right leg, arm, buttcheek and back; Dermatitis; the rash/it is red; This is a spontaneous report from a contactable Consumer (patient). A 63-year-old female patient received bnt162b2 (lot number: EL3249, Expiry Date: May2021), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. Medical history included Hiatal hernia, heartburn and stuff. The patient's concomitant medications was unspecified medication for heartburn and stuff. The patient previously took clindamycin and allergy. The patient received vaccine on 15Jan2021, started developing severe blistering raised rash on right leg, arm, buttcheek and back on Jan2021. The patient experienced rash, now raised and blistering. On 15Jan2021, legs butt cheeks on back right side of body (same side of body) burning sensation. Patient got a dermatitis on Jan2021. She don't know what dermatitis looks like but the rash she got, it like raised up and it is red and some of it is like blistered. Because she got like a blistering rash at first it was just a rash then it started kind of blistering. They have gotten worsened, they started Monday or Tuesday (Jan2021), the rash started but its got worse since then and spread. She just put some Calmoseptine on it. It is over the counter, it is almost like a diaper rash that she used on it. But she kind of got like the burning sensation too. Its an ointment. It is like a diaper rash ointment. She figured she would try that because she did an antibiotic ointment (Unspecified Ointment) and it didn't work at all. The outcome of the event burning sensation was unknown, other events was not recovered.
63 2021-02-09 weakness left ear ringing; bad headache; nauseous; no energy; I don't feel well; This is a spontaneous report... Read more
left ear ringing; bad headache; nauseous; no energy; I don't feel well; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Elo142), via an unspecified route of administration into the left arm on 14Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included calcium (CALCIUM), vitamin d3 (VITAMIN D3) and monascus purpureus (RED YEAST RICE). On 14Jan2021, patient experienced bad headache, was nauseous, had no energy and was not feeling well. On 15Jan2021, patient also experienced left ear ringing. The patient received no treatment for the events reported. Outcome of events was recovering.
63 2021-02-17 numbness This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.
63 2021-02-17 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EK9231, intramuscularly into the left arm on 05Jan2021 at single dose for covid-19 vaccination. Medical history included in Dec2020 around 23Dec2020 she tested positive for Covid-19. There were no concomitant medications. Patient said that because of the time of her retirement, she went to the VA and got the vaccination the first week of Jan2021. She said that with the first vaccination she said that she had chills, fever, and her arm hurt real bad. She said that her symptoms came on during the night. She mentioned she had experienced some side effects which went away after a few days. She had herself tested last 06Jan2021 (also reported as 07Jan2021, pending for clarification) for Covid-19 antibodies which turned out positive and PCR which turned out negative. The outcome of the event "Covid antibodies which turned out positive" was unknown, while outcome of other events was recovered in Jan2021.
63 2021-02-21 numbness Sudden numbness, dizziness on and off, numbness receded. Pt encourage to stay but refused and left ... Read more
Sudden numbness, dizziness on and off, numbness receded. Pt encourage to stay but refused and left facility. Instructed to follow up with PCP. 1520 BP 108/58, HR 76, OSat 98% 1540 BP 110/64, HR 76, OSat 97%
63 2021-02-21 flushing nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after secon... Read more
nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after second immunization (approx. 18 hours post) and lasting approx. 12 hours, some residual abdominal pain and nausea for an additional day
63 2021-02-23 tenderness Patient received 2nd dose of Pfizer COVID vaccine. Blanching, erythematous, somewhat serpiginous ras... Read more
Patient received 2nd dose of Pfizer COVID vaccine. Blanching, erythematous, somewhat serpiginous rash to L arm and hand with blister present on medial aspect of proximal forearm. Not pruritic, not painful. Area with blister is tender to the touch. Rash is not present on the L shoulder, R arm, or back. Denies fevers. 2nd dose of COVID vaccine to L arm last Thursday. The rash seems to originate from the vaccination site and does not extend upwards. The rash was noticed only today during an office visit. Patient has an intellectual disability, and very independent. always wears a long sleeve and her caregivers had not noticed it until today when rash extended down to her hands below the long sleeve.
63 2021-02-24 feeling cold, pain in extremity Sharp shooting pain down arm at time of injection. Subsided quickly and then 20 minutes later arm g... Read more
Sharp shooting pain down arm at time of injection. Subsided quickly and then 20 minutes later arm got sore, painful to lift or move around. Icy feeling and aching when arm is quiet. Painful to rotate shoulder. Some dizziness and lightheadedness.
63 2021-02-25 cold extremities, numbness, tingling, tremor Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in... Read more
Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb/Arm still has this sensation (like sleep, cold, numb feeling); Arm still has this sensation (like sleep, cold, numb feeling); Fever 102 degrees Fahrenheight; Feeling sick; Chills; Shakes; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date: Mar2021), intramuscularly on the left arm on 07Jan2021 (09:00) at a single dose for COVID-19 immunization at the school/student health clinic (not a military facility). Medical history included ongoing rheumatoid arthritis diagnosed about 5 years ago; ongoing high blood pressure diagnosed a couple of years ago, and ongoing Grave's disease diagnosed about 30-32 years ago. Concomitant medications included ongoing hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis; and levothyroxine sodium (SYNTHROID) for Grave's disease. On 07Jan2021, the patient had cold sensation in the arm, tingly sensation down in her arm like her arm was cold/numb; arm still had the sensation (like sleep, cold and numb feeling); had fever with body temperature of 102 degrees Fahrenheit; was feeling sick; had chills; shakes; and fatigue. The outcome of the events was not recovered for 'cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb' and 'arm still had the sensation (like sleep, cold and numb feeling)'; was recovered on 09Jan2021 for 'fever with body temperature of 102 degrees Fahrenheit', 'chills', 'shakes' and 'fatigue'; and was recovered in Jan2021 for 'feeling sick'. The patient was asking if these same symptoms should be expected after the second dose, and if it would be okay to get the second dose of vaccination.
63 2021-02-25 discomfort Inflammation on right side of neck throat and back area. Causing choking feeling of right side of n... Read more
Inflammation on right side of neck throat and back area. Causing choking feeling of right side of neck/ throat for approx. 8-10 hrs. .............Took several days to a gradual subsiding. Pressure felt in back of neck as well.... Same side loud tinnitus in right ear....took a couple days to subside.........during heightened swelling in nick muscles chest/ heartburn. Subsided after a short while.
63 2021-02-25 discomfort Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Detai... Read more
Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Patient stated she was experiencing some \"pressure and swelling under her upper ribcage\" and that she has had this reaction in the past when she accidently inhaled some chemicals. Patient was given one dose of Epinephrine IM into her left thigh and felt relief in pressure after 3 minutes. Patient was advised that if she experiences other symptoms to go to the ER.
63 2021-02-25 burning sensation anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning s... Read more
anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on 20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.
63 2021-02-25 pain in extremity general aching joint pain, headache, spine pain not muscle pain felt like back was broken started ar... Read more
general aching joint pain, headache, spine pain not muscle pain felt like back was broken started around midnight lasted untill late evening. left thigh pain like someone was doing a vein stripping. nausea no vomiting. Felt bad for 2 days. reddness on left arm not at shot site with left arm pain for 2 days. reddness in lt arm still there 02-26-2021.Red raised area warm no drainage.
63 2021-02-25 feeling hot got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomf... Read more
got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.
63 2021-02-25 tingling, numbness tingling and numbness on left side of mouth and face, beginning immediately after injection, and con... Read more
tingling and numbness on left side of mouth and face, beginning immediately after injection, and continuing intermittently for two days so far. Exacerbation of rash on right hand that usually occurs when exposed to wheat, beginning 24 hours after injection. Muscular pain in back beginning 12 hours after injection and subsiding 40 hours after injection.
63 2021-02-26 difficulty speaking 10 minutes after receiving vaccine pt reports throat swelling and hoarse voice. Mouth assessed, no s... Read more
10 minutes after receiving vaccine pt reports throat swelling and hoarse voice. Mouth assessed, no swelling noted to throat/lips/face. Pt's HR 74, BP 150/90. Ambulance called to scene and pt reporting improvement in symptoms upon ambulance arrival. Report provided to Paramedic, pt transported via ambulance to local hospital.
63 2021-02-26 migraine Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific.... Read more
Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific. Went to be early at 9:30 and awoke at one a.m.on February 26 with splitting headache. Could not get back to sleep well and felt terrible all that day with headache, nausea, and foggy thinking, not funcional after about 2:30 p.m. Took Ibuprofen at 3 p.m., called doctor and went to ER at Medical Center. Was seen at ER a few hours later. Slept some in waiting room. Had sore throat, the worst splitting migraine type headache ever, and was extremely foggy headed, couldn't process thoughts, eyes had difficulty focusing, nausea. My temperature was a little high for me, I am normally low and it was 99. My blood pressure is usually low and it was 105/59, pulse was 82 and respiration was 16 with 96 % Oxygen Saturation. They did tests and had an ophthalmoligist give me an exam also. They said I could go home with the same meds they were giving me in the hospital since they were working to alleviate my painful headache, 600 mg of ibuprofen, reglan and benadryl. Before I left they gave me the potassium chloride. I am continuing my medications today, two days after my vaccine.
63 2021-02-28 weakness Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction... Read more
Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction analogous to exacerbation of her autoimmune disease (LUPUS) which had been in remission (on medication) for 5 years.
63 2021-02-28 numbness PATIENT HAD A SEVERE ALLERGIC REACTION TO THE VACCINE. A COUPLE OF HOURS AFTER THE VACCINE, SHE HAD ... Read more
PATIENT HAD A SEVERE ALLERGIC REACTION TO THE VACCINE. A COUPLE OF HOURS AFTER THE VACCINE, SHE HAD SHORTNESS OF BBREATH, CHEST TIGHTNESS, NAUSEA AN VOMITING, FACE NUMBNESS AND TINGLING, AND HIGH BLOOD PRESSURE.
63 2021-02-28 muscle twitching Patient experienced twitching in her arm following injection. BP readings 150/110 and 130/100 HR 64 ... Read more
Patient experienced twitching in her arm following injection. BP readings 150/110 and 130/100 HR 64 95% O2 on RA BGL 90
63 2021-02-28 burning sensation Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chi... Read more
Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chills aches and pains and headache the latter lasted three days
63 2021-02-28 nerve pain, tingling Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, E... Read more
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Dose potentially administered too high but patient didnt bleed. Banaid placement described as one finger width below acrimion bone. Immediately \u2026 at the time of injection \u2026 shooting nerve pain radiating down the arm into fingers. Pain became a hot tingle over the next 15-30 minutes. Impaired right arm mobility and range of motion \u2026 shoulder pain with motion beyond a modest range. Three days later still experiencing some pain with certain arm motions \u2026 primarily raising arm above shoulder
63 2021-02-28 feeling hot heart start palpitating and racing; kind of warm; This is a spontaneous report from a contactable co... Read more
heart start palpitating and racing; kind of warm; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 26Jan2021 11:00 at a single dose for Covid-19 immunization, and potassium chloride ER, via an unspecified route of administration from an unspecified date at 10 mg, daily (every day) for low potassium. Medical history included anxiety and was afraid to take her anxiety medicine; hypertension, and iron deficiency; all from an unknown date. Concomitant medications included amlodipine besilate (NORVASC) for hypertension, and colecalciferol (VITAMIN D [COLECALCIFEROL]). It was reported that when the patient got the shot it did not hurt but when she sat down for about a minute (26Jan2021), her heart start palpitating, and racing and then she got kind of warm and then it went away. She didn't pass out, had no shortness of breath. She just wanted to know if it was one of the side effects and that's why she need to report this. The patient was looking at the ingredients that Pfizer have like potassium and stuff. The patient takes potassium every day. She added that maybe she should have not taken her potassium at the same day, would make your heart raise that's why she was wondering. Otherwise the patient felt fine. She just needed to report this. Furthermore, patient stated that maybe because she was nervous, she was scared to take certain anxiety medicines (unspecified medications) she did not know would had it though. The outcome of the events was recovered.
63 2021-02-28 pain in extremity sore left arm/hip pain is radiating down to her leg; Knee pain; This is a spontaneous report from a ... Read more
sore left arm/hip pain is radiating down to her leg; Knee pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular in left arm near shoulder on 25Jan2021 10:20 at a single dose for COVID-19 immunization/prevent covid. Medical history included ongoing arthritis diagnosed years ago, ongoing arthralgia, has two titanium knees and she had the hip pain prior to the COVID injection but now her hip pain is radiating down to her leg. Concomitant medications included celecoxib (CELEBREX) from an unknown date and ongoing at 100mg capsule once a day by mouth for arthritis. The patient previously received the first dose of BNT162B2 (Lot: EK9231) administered on 05Jan2021 around 13:00, intramuscular injection in left arm near shoulder for COVID-19 immunization, SHINGRIX two shot dose, she had one in Dec2018 and the second one in Mar2019, stated that it hurt to where she could not even lift the arm. It was reported that on 25Jan2021, patient had the second dose of the vaccine and she had the typical sore arm 6 hours later that lasted 24 hours. She clarifies it recovered completely 48 hours later and she does not have the soreness as of today, states it does not bother her. Reports she also has it to where her knees and hip are hurting her. She has two titanium knees and she had the hip pain prior to the covid injection, but now her hip pain is radiating down to her leg. She has arthritis and with weather changes she experiences the hip pain. Her daughter told her it is a side effect of the shot. She is asking why this hip pain is radiating down. The knee and hip pain started around 9pm on 25Jan2021. Reports it is a tad better but it is painful. She does not have a fever. Treatment for the events knee pain included putting ice and heat on her knee and hip. The outcome of sore left arm/hip pain is radiating down to her leg was recovered on 27Jan2021, knee pain was recovering.
63 2021-02-28 tingling tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report fro... Read more
tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), via intramuscular route of administration in the left arm on 15Jan2021 10:05 at a single dose for COVID-19 immunization. Medical history included open cholecystectomy in 1990, hypertension, and sleep apnoea (CPAP). The patient's concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22 Dec2020 and experienced fever, nausea, vomiting, diarrhea, metallic taste in mouth, Loss of taste/smell, minimal soreness at the site of injection, strange sensation of tingling in her skull, chills, dry mouth, feels like she has no saliva, tongue felt a little bit too dry, extremely tired, thirst, and altered taste. The patient experienced mild left arm soreness on 15Jan2021 and fever 101.8 on 16Jan2021 23:00. Patient took ibuprofen 400mg and ondansetron (ZOFRAN) 4mg. The patient also experienced tingling sensation left skull continues as described. The patient had no cough, sore throat, stuffy or runny nose. She had no shortness of breath, no nausea vomiting or diarrhea, and no loss of taste/smell or metallic taste in mouth. The patient underwent lab tests and procedures which included body temp: 99.7 on 15Jan2021 18:00, 101.8 on 16Jan2021 11 PM, 99.5 on 16Jan20213 PM, 99.8 on 16Jan2021 10 PM, 99.5 on 17Jan2021 9:00, 99.8 on 17Jan2021 8 PM, 100 on 17Jan2021 10 PM, 99.4 on 18Jan2021 07:00, 99.7 on 19Jan2021 16:00, 98.6 on 20Jan2021 11 AM. Outcome of tingling sensation left skull was not recovered, of remaining events was unknown.
63 2021-03-02 discomfort, pain in extremity Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at... Read more
Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.
63 2021-03-02 facial paralysis Was notified by nurse at clinic that Patient started having right eye dripping, swelling and burni... Read more
Was notified by nurse at clinic that Patient started having right eye dripping, swelling and burning starting on Monday 3/1/21. Patient went to see her Family Dr. with complaint of right side drooping starting today 3/3/2021. She was sent to the ED at Hospital for evaluation.
63 2021-03-03 pain in extremity 2 lumps on the collarbone, in the front. She guesses, they were lymph nodes; arm hurting; This is a ... Read more
2 lumps on the collarbone, in the front. She guesses, they were lymph nodes; arm hurting; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL8982), via an unspecified route of administration on 29Jan2021 (1:00-1:30pm) at single dose on the upper left arm (arm left) for COVID-19 immunisation (reported as "age 63, diabetes, is lucky to get being a part-time educator"). Vaccination facility type was school. Vaccine was not administered at military facility. Medical history included ongoing diabetes.The patient's concomitant medications were not reported. No other vaccines given the same day or 4 weeks prior. On 29Jan2021 (Friday), patient got her first COVID shot. On 01Feb2021, patient noticed she has 2 lumps on the collarbone, in the front. She guesses, they were lymph nodes. Patient called her doctor's office and was told to call Pfizer to ask for guidance. No other vaccines given the same day or 4 weeks prior. Patient had the usual arm hurting. In the past, she had the Shingles vaccine, felt kind of achy and a little tiredness, but never had this happen before (also reported as "AE(s) following prior vaccinations: arm hurt, kind of achy and a little tiredness). Patient was going to wait to see if they go away, hoping they would go away and then if not she would make an appointment. Patient has diabetes and takes medication for that, but does not provide any further details. She wanted to know if this is something others have experienced or if this side effect has been reported or to possibly be expected. The events did not require emergency room and physician office visit. There were no family medical history relevant to events and relevant tests. Outcome of the events was not recovered (reported as ongoing).
63 2021-03-03 tingling, pain in extremity, numbness It was the Pfizer Vaccine. I received the vaccine at 11:30 am Sunday. At approximately 3:30 pm I sta... Read more
It was the Pfizer Vaccine. I received the vaccine at 11:30 am Sunday. At approximately 3:30 pm I started having a lot of pain in my legs (calves and feet) at first it was extreme pain that led to tingly prickly sensations. I went home, went to bed, was up all night in bed groaning because of the pain, and when I tried to stand, was unable to. I crawled to my phone and called my sister (who lives next door) who ran over. She has a wheelchair and took me to the hospital. I was unable to walk alone for four days and the pain was not as extreme after 5 days. I am now 3 weeks out and still have numbness in my legs.
63 2021-03-03 pain in extremity, pain in extremity Patient received Pfizer dose#2 on 1/2/2021. Then approximately 3 weeks post vaccine, she began to ex... Read more
Patient received Pfizer dose#2 on 1/2/2021. Then approximately 3 weeks post vaccine, she began to experience acute upper arm/ clavicular joint pain and bilateral hands were "cupped". Received steroid treatment from PMD.
63 2021-03-03 tingling Pe state her left corner of her mouth is "tinging" pt states the same thing happened with first dose... Read more
Pe state her left corner of her mouth is "tinging" pt states the same thing happened with first dose vaccine but this time "was worse". Pt refused Benadryl at first. Pt denied shortness of breath. Vitals at time of report 136/83. 1700 vitals 142/73. 1702 pt took Benadryl 25mg PO. at 1710 137/77 pt declined any further treatment and was released ambulator
63 2021-03-03 burning sensation Skin around the eye area feels like it us burning. No outward signs or rash, no swelling. Just burni... Read more
Skin around the eye area feels like it us burning. No outward signs or rash, no swelling. Just burning feeling and face feels like it's cracking when blinking or squinting. No fever or rash.
63 2021-03-04 pain in extremity Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as w... Read more
Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as well as my cheeks. Then my lower lip began to swell. I would consider these symptoms somewhere between mild to moderate. The symptoms began around 4:30 in the afternoon and subsided as the evening progressed. The next morning (today), my face feels basically normal again. My only symptoms now are a sore arm and a slight headache. I have experienced allergic reactions before but never from a vaccine.
63 2021-03-08 slurring Patient reports having slurred speech beginning 2000 the evening following vaccination. She presente... Read more
Patient reports having slurred speech beginning 2000 the evening following vaccination. She presented to the ER on 02/11/2021 and admitted to hospital for Acute CVA. Discharged on 02/14/2021. Patient's PCP recommended completion of series.
63 2021-03-10 numbness, pain in extremity Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced c... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced chest pain radiating down left arm, shortness of breath, and nausea. Patient also endorses numbness to left upper arm and left lower leg. Denies any wheezing, throat swelling, facial swelling, diarrhea, urticaria. Vitals: BP 104/65, Pulse 78, SpO2. On chart review, she had similar symptoms in the past with full stroke workup that was ultimately determined to be conversion disorder. Admitted for observation to rule out ACS. EKG and serial troponin unremarkable.
63 2021-03-10 pain in extremity pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; S... Read more
pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown. Information on lot and batch number has been requested.
63 2021-03-14 feeling cold drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of n... Read more
drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of nasal congestion; chest congestion; productive cough; sinus infection; allergy symptoms; testing positive for Covid infection following administration for the first vaccine dose; testing positive for Covid infection following administration for the first vaccine dose; sore throat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in Deltoid Left on 19Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included Slightly elevated blood pressure from Feb2021 and ongoing, Elevated cholesterol from Feb2021 and ongoing. Concomitant medication included pravastatin (PRAVASTATIN) from Feb2021 and ongoing for Elevated cholesterol, lisinopril (LISINOPRIL) from Feb2021 and ongoing for Slightly elevated blood pressure. The patient experienced testing positive for covid infection following administration for the first vaccine dose on 04Feb2021. COVID: Initially reported onset of symptoms as 29Jan2021, but clarified onset of symptoms night of, or morning of 28Jan2021. She always had allergy symptoms like a drippy nose; she was getting ready to go get allergy testing in a few weeks; but on 28Jan2021 she noticed a real increase of sicker drainage all through the night. She thought she might had had a sinus infection. She felt cold and chills but no fever; she never had a fever; but had chills daily. She also had really bad sore throat that went away the next day; and lots of nasal congestion; chest congestion; productive cough. She still had nasal congestion and a little bit of chest congestion but chest congestion was very light in color. She had had no trouble breathing or shortness of breath; other than from her nose being stopped up. Seriousness criteria: Caller reported no emergency room visit, doctor's office visit or hospitalization related to this event. The patient underwent lab tests and procedures which included Flu test: unknown results on 03Feb2021, SARS-CoV-2 RT-PCR test: positive on 04Feb2021. The outcome of event sore throat was recovered 1 day later on unspecified date, lots of nasal congestion was not recovered, while for other events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
63 2021-03-17 facial paralysis Twenty seven days after my second vaccination I developed Right side of face paralysis and went to E... Read more
Twenty seven days after my second vaccination I developed Right side of face paralysis and went to ER. After steroids and valcyclovir I was 100 percent recovered.
63 2021-03-21 muscle spasms c/o of left arm cramping and dizziness. required a wheelchair. no meds for intervention needed.
63 2021-03-24 weakness Pale and shaky; Pale and shaky; Blood pressure bottomed out; Heart was racing, her heart was beating... Read more
Pale and shaky; Pale and shaky; Blood pressure bottomed out; Heart was racing, her heart was beating really hard/pounding chest; Weakness; Fast heartbeat/Pounding chest; Lightheadedness; Insomnia; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 10Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient reported). A 63-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 at unspecified route in left arm on 08Mar2021 11:30 as a single dose (at the age of 63 years) at for COVID-19 immunisation. Medical history included iodine allergy from an unknown date and unknown if ongoing severe allergy , drug hypersensitivity from an unknown date and unknown if ongoing severe allergy , dysphagia from an unknown date and unknown if ongoing , ongoing Sjogren's syndrome diagnosed 33 years ago , ongoing systemic lupus erythematosus diagnosed 3 years ago , ongoing headache , ongoing intervertebral disc degeneration diagnosed with this about 15 years ago , ongoing fibromyalgia diagnosed 10 years ago , Meniere's disease from an unknown date and unknown if ongoing , supplementation therapy from an unknown date and unknown if ongoing Vitamin c (Verbatim): recommended by dentist bone health and teeth. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for supplementation therapy from 2020 and ongoing; vitamin d3 (VITAMIN D3) taken for hypovitaminosis from 2019 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for hypovitaminosis from Apr2020 and ongoing; timolol (TIMOLOL) taken for glaucoma from 2011 and ongoing; alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for dyspepsia from an unspecified start date and ongoing; cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) taken for fibromyalgia from an unspecified start date and ongoing; cetirizine hydrochloride (GENERIC ZYRTEC) taken for hypersensitivity from 2011 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; olanzapine (OLANZAPINE) taken for bipolar disorder from an unspecified start date and ongoing; docusate sodium (COLACE) taken for constipation from an unspecified start date and ongoing; lactulose (GENERLAC) taken for constipation from 2018 and ongoing; acetaminophen (TYLENOL GENERIC) taken for headache, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; tramadol (TRAMADOL) taken for intervertebral disc degeneration, headache from Dec2020 and ongoing; triamcinolone diacetate (TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]) taken for rash from 2018 and ongoing; meclizine hydrochloride (MECLIZINE HYDROCHLORIDE) taken for dizziness, start and stop date were not reported. The patient experienced heart was racing, her heart was beating really hard/pounding chest on 08Mar2021 with outcome of recovered , pale and shaky on 09Mar2021 with outcome of recovered weakness on 08Mar2021 with outcome of recovered , fast heartbeat/pounding chest on 08Mar2021 with outcome of recovered , lightheadedness on 08Mar2021 with outcome of recovered , insomnia on 08Mar2021 with outcome of unknown , blood pressure bottomed out on 09Mar2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 'bottomed out' on unspecified date 09Mar2021, heart rate: 95, heart rate: 98-101, heart rate: fast. Therapeutic measures were taken as a result of , insomnia. No vaccines administered on same date with the Pfizer vaccine. No vaccinations within four weeks prior to the first administration date. No ER visit or physician office visit reported.
63 2021-03-28 feeling hot Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (... Read more
Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (severe) Brain "fog" (severe) Sensation of overheating / burning Fever (few mild elevations) Loss of Appetite /Indigestion (resolving as of March 26)
63 2021-03-28 tremor had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since ... Read more
had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since 18 years so now it's heavy; Headache; Acne/cramping/was very irritable/it was PMS; tremor; an itchy chest including nipples/itchy rash, not swollen but a rash on chest and nipples which were itchy; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 06Mar2021 14:45 (Batch/Lot Number: EL3302) as a single dose for COVID-19 immunization. Medical history included Parkinson's, hypothyroidism, aortic insufficiency, allergies: penicillin, tea tree oil, latex, whey. Patient is not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1998 and ongoing, carbidopa, levodopa (CARBIDOPA LEVODOPA) taken for Parkinson's disease from Feb2013; and estradiol (VIVELLE DOT) for estrogen therapy. Patient previously took prochlorperazine edisylate (Compazine) and morphine and experienced allergies for both. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has not had a period for 18 years. On 07Mar2021 12:00, patient got an itchy chest including nipples, irritability, acne and a heavy full blown period with clotting, cramping, etc. AE resulted in doctor or other healthcare professional office/clinic visit. Events were also reported as follows: patient experienced itchy rash, not swollen but a rash on chest and nipples which were itchy. Patient had Parkinson's and her symptoms got worse. She just went to her neurologist and thought that was a little strange and patient had headache. It was reported that she was irritable, it was PMS. Then patient had full blown period and patient have not had period since 18 years so now it was heavy. Patient had neurology appointment a short time ago and she was doing great and she also had her urology appointment on 23Feb2021 and everything was fine. Patient did use Vivelle-Dot which is half of a milligram, it is an estrogen therapy, but patient have never had any problems with bleeding at all, "nothing like that ever". Itching started on 06Mar2021, and then over the next couple of days, patient started having headaches, irritability, cramping, just overall Parkinson's symptoms, and tremor (medication wasn't controlling her tremor anymore). Patient has not recovered from the events.
63 2021-03-31 tingling, breast pain, pain in extremity Tingling on her lip/ zap or electrical like feeling in her upper lip; tingle on the right hand finge... Read more
Tingling on her lip/ zap or electrical like feeling in her upper lip; tingle on the right hand finger/ electrical feeling; sharp pain in her breast/ painful zinging sensation on her right breast; excruciatingly painful electrical feeling like a zing that shot from her left foot and ankle to her calf; pain that came up the outside left ankle/ zinging sensation left ankle; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in the left arm on 02Mar2021 11:00 AM as a single dose for COVID-19 immunisation. Medical history predating treatment with the Pfizer COVID 19 vaccine included fracture on that left foot where the toenail came off and she had a wound that wouldn't heal. She was fully recovered from the foot injury in Dec2020. Then she came down with a positive COVID 19 test on 11Dec2020. Symptoms started on 07Dec2021 with a fever and everything and she ended up in the ER with bilateral pneumonia and they sent her home on 17Dec2020. Then later, she was admitted to the hospital on 25Dec2020 with excruciating pain in her chest, lungs and legs; and she was having shortness of breath. She was found to have a DVT, PE and bilateral pneumonia. She was discharged 30Dec2020. She thinks she has the long time syndrome after COVID. She was still having shortness of breath, itchiness, and extreme fatigue from the COVID 19 infection but her HCP advised her to get the COVID 19 vaccine anyway. She thinks the chest congestion and cough were cleared up now, but she has noticed hair loss. The patient had no concomitant medications. The patient stated that her husband, son and herself received the first dose of the Pfizer COVID vaccine on 02Mar2021. They all waited the 15 minute waiting period after receiving the vaccine for a reaction and was fine. Her husband and son went ahead to the car and she went to use the restroom. 20 minutes later, while in the restroom, she got a random ting outside her left foot like an electrical type very painful pain that came up the outside left ankle, leg, and calf. She had an excruciatingly painful electrical feeling like a zing that shot from her left foot and ankle to her calf/ zinging sensation left ankle on 02Mar2021. The pain was from the same foot that she had broken before. It happened once and she was like what was that and then it stopped. Maybe 5 seconds went by then it happened again this random zap of electrical feeling that she cant really explain but it gave her whole body goosebumps. It did it 5 times in a row with pauses in between in the same exact place left lower leg. After it stopped and as she was washing her hands she had a really sharp pain in her breast on 02Mar2021 and then that was it. She walked out to the car and she didn't say anything to her husband or son because she didn't really understand what was happening and she felt fine other than the crazy pain and once it ended it ended. When she got home and in the afternoon because she was home working remotely it happened again the same exact spot left lower leg and the pain was excruciating when it was happening. This time she thinks it was four times in a row with pauses in between same exact spot just in her left lower leg. This time she told her husband "I didn't say anything before but its happening again and its weird." She never had this feeling before. Adds it was so excruciating. She was just holding her breath counting how many times it will occur. It happened again that night and then she almost afraid to go to sleep because the pain would wake her up but nothing happened as she slept. She woke up the next morning and had to go to an ophthalmologist appointment and happened again while she was sitting in the chair. She had another episode of the painful zing in her foot. That was the last time it did and it might have happened again but altogether she had 4-5 episodes in a 24 hour period after receiving the vaccine. Each time she would have several painful zings. She also noticed a tingling on her lip on 03Mar2021; a painful zinging sensation on her right breast; and a tingling sensation on one finger of her hand that happened one time on 03Mar2021. That day, she had a tingling in one finger and a zap or electrical like feeling in her upper lip and that was it those didn't really bother her they were more tingling and electrical feeling. She called her primary doctor and he hadn't heard of anything like it before but he cant rule it out. He said the only way you would know is if you got the shot again but she states she is a little scared. She would like to know if this side effect has been reported before and if she should get the second dose of the vaccine. She was scheduled to receive the next dose on next Tuesday, 23Mar2021. She mentioned she had blood work this week but she has no results at this time. The outcome of sharp pain in her breast/ painful zinging sensation on her right breast was recovered on 02Mar2021, of excruciatingly painful electrical feeling like a zing that shot from her left foot and ankle to her calf was recovered on 03Mar2021, of pain that came up the outside left ankle/ zinging sensation left ankle was recovered on 04Mar2021, of tingling on her lip/ zap or electrical like feeling in her upper lip was recovered on 03Mar2021, and of tingle on the right hand finger/ electrical feeling was recovered on 03Mar2021.
63 2021-03-31 nerve pain, pain in extremity Woke up with extreme pain by my shoulder blade, down my arm on March 13th. Used NSAIDS for a couple ... Read more
Woke up with extreme pain by my shoulder blade, down my arm on March 13th. Used NSAIDS for a couple of days with no relief. Went to ED Triage nurse to ask for guidance on next steps. Went to urgent care on 3/15/21 and was prescribed muscle relaxers for muscle pain with no relief in my shoulder and arm. Appointment with orthopedic doc, on 3/17/21. He ordered an MRI of C-spine and diagnosed nerve pain. Pain traveled from arm to hand and back to shoulder then repeated 24/7. Used ice-packs, and alternated with heat. Second appointment with Dr. on 3/23/21. Discussed nerve pain and Parsonage Turner Syndrome.
63 2021-04-01 bell's palsy onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue,... Read more
onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had Bell palsy; Awakened with brief episode (10 min) severe abdominal pain; Severe muscle aches; Head pain; Neck pain; Developed sore on left side of tongue; Neck/mastoid pain; Swollen gland lasted a few days; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6200, Expiry Date: unknown) via an unspecified route of administration in left arm on 24Feb2021 13:30 at single dose for COVID-19 immunisation. Patient had historical vaccine at 63-year-old BNT162B2, lot number: EL9262 at left arm on 03Feb2021 13:30 at SINGLE DOSE for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's medical history included penicillin and neomycin allergy. Patient's concomitant medications included ergocalciferol (VIT D), rosuvastatin calcium (CRETOR) (medications the patient received within 2 weeks of vaccination). On 25Feb2021, the patient experienced onset of symptoms of left-sided bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had bell palsy, awakened with brief episode (10 min) severe abdominal pain, severe muscle aches, head pain, neck pain, developed sore on left side of tongue, neck/mastoid pain, swollen gland lasted a few days. Event was reported as on 25Feb, patient awakened with brief episode (10 min) severe abdominal pain. Later, severe muscle aches, head and neck pain, lasted until following Wednesday (03Mar). Patient developed sore on left side of tongue, neck/mastoid pain, swollen gland; lasted a few days, then noted onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). By friday 12Mar she knew she had Bell palsy. Medrol dosepak, OTC pain meds was received as treatment for adverse events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-04-01 feeling cold, muscle spasms, weakness rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso... Read more
rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.
63 2021-04-07 pain in extremity Only initial side effect following both injections was moderately sore arm and fatigue. Following 2... Read more
Only initial side effect following both injections was moderately sore arm and fatigue. Following 2nd dose I experienced 1 episode of severe vertigo while just sitting doing nothing. Dizziness cleared completely in about 4 minutes. Then on March 13th, was at work, sitting at desk and same thing happened again. After the dizziness cleared I got up and went to see a patient. I work in a rehab unit of a hospital. Got pt approx 50 feet down the hallway when dizziness started coming back. Handed patient over to other staff. I took my blood pressure and checked my blood sugar. Both WNL . Dizziness never got better. Went to ER. They had no clue of cause. All labs were normal. Saw Physical therapist who performed Eply maneuver as well as a ENT. Both got same result. Negative for BPPV. MD gave me Antivert. Didn't work. Are waiting to be seen in May 2021 for NVT test and another with Neurologist. In the meantime the dizziness has remained constant rendering me unable to return to work.
63 2021-04-09 tenderness Chills, fever-diminished sweats-resolved 4/5/2021 migrating erythema, tenderness under erythema, ... Read more
Chills, fever-diminished sweats-resolved 4/5/2021 migrating erythema, tenderness under erythema, anorexia, bladder irritation-persistent
63 2021-04-09 pain in extremity arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a li... Read more
arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a little bit; woke me up at 5 O'clock this morning in pain; shoulder is kind of swollen; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; arm kind of still stiff and sore; Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613 and expiration date not provided) via an unspecified route of administration administered in the arm, on 23Mar2021 as a single dose for COVID-19 immunization. Medical history included breast cancer survivor. The patient's concomitant medications were not reported. The patient stated that she was trying to figure out what to do. On 26Mar2021, her arm started to swell a little bit. When she woke up, it woke her up at 5 o'clock in pain and her shoulder was kind of swollen, it has got big old knot and it was red and it was apparent itchy and she could not scratch it so, she thought about it and she got an ice pack, so she put ice on it. She was holding ice on it now, trying to sooth it. She was wondering where she would go for reaction, she knew she had reaction like this before so she had a side effect from it, and her arm was kind of still stiff and sore. She did not go to the emergency or urgent care because she looked at left and she looked at the right and like she said, it was swollen and she got big old knot and it was red. She also stated that she did not take Tylenol today. She did not know what she wanted to get through to somebody and she needed to speak to somebody on what she needed to do. She also said that on an unspecified date in Mar2021, in her stool, she found some blood. She had another appointment with her "thyroid" (not clarified) and she does not know the results yet. The outcome of the events was not recovered. Information about lot/batch number has been requested.
63 2021-04-09 muscle spasms, pain in extremity pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circ... Read more
pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circle around it and it's hard; she had a little bit of pneumonia; got a fever; felt like she couldn't go to the bathroom, cramps; had trouble breathing; the site was red; swelling/her arm is swelling; it does hurt her, right in that area where the shot was given; arm was sore and achy/her arm started aching; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6208, expiration date unknown), via an unspecified route of administration, administered in left arm on 22Mar2021 at the age of 63 years old at a single dose for COVID-19 immunisation. Medical history included ongoing pre diabetic, ongoing high blood pressure, ongoing non-alcoholic liver disease, edema, to help her breathe, pneumonia, COVID in 2021, respiratory problems, asthma, little bit of obesity, swelling in her legs, varicose veins. Concomitant medications included benzonatate at 100 mg to help her breathe, azithromycin (six pills of that, 200mg, two one day and one pill a day until gone) for pneumonia. Patient had her second dose scheduled on 12Apr2021. She explained after the shot, her "arm was sore and achy" she said she also had "pain". She added she experienced "flu-like symptoms". She specified these adverse reactions are all gone now but her arm is still "a little sore" and she has one area with a "big circle around it and it's hard". She said it could be "swelling". She asked if her reaction was reported as side effects to the vaccine. She expressed being in a rush and is expecting her daughter soon and asked us to be quick. She said she will also consult with her HCP this afternoon. Patient stated she had the first shot on Monday 22Mar2021 and today and last night the site was red, but today in that area she has gotten a big circle around it and its hard. Patient stated she's had it before with shots and just wanted to make, sometimes she has had to be put on medicine for it, wanted to be sure its healing because it does hurt her, right in that area where the shot was given. She also stated that after she has her second shot on 12Apr2021, she would like to talk to somebody and she would like to be able to have people in her home. She was reporting she had COVID three weeks ago, would she be ok after the 2nd shot to go out? She stated her daughter thinks she needs to wait until the end of April. She verified she did receive the Pfizer BioNtech Covid 19 vaccine. Swelling: Patient stated her arm is swelling. Also stated she always gets that and today there's a circle there and it is red and hard. Also stated occurred after the shot. Patient reported that the shot hurt like heck and she couldn't really tell, she has big arms, she knows it was swollen. Reported she took over the counter medicines, last night she noticed it was a circle and it was hard there. Stated area is not swelling anymore, now just one hard red circle. Red and a hard circle: She also reporting her entire arm ached after the shot, she stated she knows her entire muscle was aching. Stated it was swollen quite a bit but now its just red and a hard circle, and it's ongoing. Arm swelling outcome: Patient reporting yesterday afternoon, she was feeling better, except that one spot. She stated it does hurt when she bends it because she had that one little area that's swollen. Also stated the swelling started later that afternoon after the shot. Reported she went for a walk with her daughter and her arm started aching. It felt like she couldn't go to the bathroom, cramps. It felt like she had a little bit of the flu, and it was from the shot but it only lasted a few days. Stated that part went fast, got a fever, other than that, just the one area on her arm. Stated she doesn't even feel sick from the shot or anything. Stated she had Diarrhea: Stated she had diarrhea in the beginning after the shot then had trouble going to the bathroom. Stated she thinks its because she has IBS and that's how her body is. She doesn't know if that's from the shot or not because that's how her body always is. Pfizer BioNtech Covid 19 Vaccine: Patient stated she doesn't want COVID again. She has respiratory problems anyway, she has asthma and a little bit of obesity. She states she was in fear of herself. She doesn't do well with hospitals and being put under with that medicine. Also stated patient knew COVID causes a lot of people having trouble breathing and she doesn't want to end up on a breathing tube where its breathing for her and she never sees her family again. Caller states it kind of scared her. Patient stated her niece and nephew, whos got it worse. She stated she went to the hospital and haven't been back. She stated she was hospitalized about 2 weeks ago, and that's when she was diagnosed with COVID, before she got the first COVID shot. About the medical history, non-alcoholic liver disease: Stated diagnosed about eight years ago, she would say the same time, about 7 to 8 years ago because she had a virus and when she went in the hospital, the virus had attacked her right kidney and liver. She stated with non-alcoholic liver disease, she is overweight, and that causes her to have issues with her liver. The last few times her liver has been okay. Pre-Diabetic: They have been watching that for a while. Stated she gets edema, swelling in her legs, well, all the time. She has had this the last two years because she is pre-diabetic and a lot of overweight people have that. She also has varicose veins so that doesn't help. Stated that was given those to help break up, because she had pneumonia when she got the COVID and she had a little bit of pneumonia and had trouble breathing. The patient was recovering from arm was sore and achy/her arm started aching, swelling/her arm is swelling and for other events it was recovering.
63 2021-04-09 weakness sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weak... Read more
sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weakness; lower abdomen hurt; tired; vomiting; diarrhea; sweaty; little bit of rectal bleeding after diarrhea; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in Left upper arm on 24Mar2021 (Batch/Lot number was not reported; Time the Vaccination Was Given was around 15:30) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid, renal disorder from an unknown date and unknown if ongoing , diabetes from an unknown date and unknown if ongoing, blood pressure measurement from an unknown date and unknown if ongoing, vaginal disorder from an unknown date and unknown if ongoing, colitis from an unknown date and unknown if ongoing. Reported following prior vaccinations was stated she had a sore arm sometimes with the flu shot and felt kind of sick but not always. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid from an unspecified start date and ongoing (reported she started taking this decades ago); metformin (METFORMIN) taken for diabetes from an unspecified start date and ongoing ((reported she started taking this decades ago); lisinopril (LISINOPRIL) to protect kidneys with diabetes and for blood pressure, started years ago and took a small dose, stated her blood pressure was usually fine; estradiol (ESTRACE) taken for when the vaginal tissues get disintegrated from an unspecified start date and ongoing (stated she started this a very long time ago). The patient experienced little bit of rectal bleeding after diarrhea on 25Mar2021 with outcome of unknown, sick on an unspecified date with outcome of unknown, tired on 25Mar2021 with outcome of not recovered, vomiting on 25Mar2021 with outcome of unknown, diarrhea on 25Mar2021 with outcome of unknown, sweaty on 25Mar2021 with outcome of unknown, exhausted/wiped out on an unspecified date with outcome of unknown, stomach kind of hurts on 25Mar2021 with outcome of unknown, started to feel lousy on 25Mar2021 with outcome of unknown, tiny bit of dizziness on 25Mar2021 with outcome of not recovered, weakness on 25Mar2021 with outcome of unknown, lower abdomen hurt on 25Mar2021 with outcome of unknown. The event little bit of rectal bleeding after diarrhea considered serious as medically significant. The AEs not require a visit to Emergency Room or Physician Office. Received the first dose of the Pfizer Covid 19 vaccine Wednesday afternoon, yesterday, patient felt okay, but was off, got really sick in the middle of the night. during the day , tired, expected that, but at night vomiting, diarrhea and weak, sweaty, kind of bad. it stopped today she was just exhausted and her stomach kind of hurts. She was better than last night, today she was just more worn out by this, she took a Imodium. She had the vaccine Thursday afternoon and yesterday she felt lousy, nothing severe and last night she was very sick. Stated she was still trying to get better today. Stated she called and left a message with the FDA/CDC vaccine adverse event reporting system a little while ago. Caller clarifies she got the vaccine on Wednesday 24Mar2021 and that she started to feel a little lousy 25Mar2021, more like the symptoms that are described, she was tired and had a tiny bit of dizziness that came and went, it was mostly tired. Stated in the middle of the day she laid down for an hour and that was around lunch time. Stated the dizziness was off and on like when she was driving and just here and there. Stated the tired was still persisting. She stated she did not have NDC, lot, expiry date or dose to provide. Stated she see EUA on the sheet but not much else. Stated it was the 1st dose. Stated she forgot to tell about last night. Stated she woke up around midnight very sick with vomiting and had diarrhea and was sweaty. Stated her stomach hurt and her lower abdomen hurt. Stated she was not sure if these are from the vaccine or a coincidence. Stated she had stopped throwing up, just did that a few times. Stated the diarrhea stopped after a little while. Stated she still has abdominal pain today and weakness was with the diarrhea and she would lay down in bed. Stated she was still a little weak, that she was more wiped out and tired. Caller stated she was bleeding a little bit after the diarrhea and it scared her because a couple years ago she had colitis and it scared her, that she called a relative who is a retired nurse and she thought it was from the diarrhea. Caller clarified she contacted her relative about this current event with the bleeding. Caller provided that she took Imodium this morning and has been sipping on water and had a little breakfast, she thought she may be a little dehydrated. Patient stated her symptoms were pretty bad last night, it was acute. Patient clarified that it was rectal bleeding and it was just a little this morning. Stated it happened last night and again this morning. Stated she was not sure if it was still occurring and hopes it stopped as it it's scary. Stated today she was just resting and trying to get better. Patient said that if it gets worse she will call her doctor and that she had called the hospital last night and they didn't have anything to say. Stated that if it was from the vaccine she was hoping that it's very temporary and went away and be gone if it was from the vaccine. Patient was asking if there was information about the chance that this was related to the vaccine, stated they were not listed as possible side effects. Stated she had people from the hospital and relatives she has talked to that say it may be. Information on the lot/batch number has been requested
63 2021-04-11 pain in extremity 12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21. Then on... Read more
12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21. Then on 4-7-21, my left leg calf was very sore and hard for me to walk, Got worse, so on 4-9-21 went into Urgent care and through a vascular ultra sound determined I had a very Large blood clot in my calf. (ACUTE THROMBOSIS OF THE LEFT PROXIMAL PERONEAL VEIN)
63 2021-04-13 muscle spasms 2/28/21 Four days after 1st Pfizer vaccine 2/24/21 Severe cramping and swelling in my right leg ... Read more
2/28/21 Four days after 1st Pfizer vaccine 2/24/21 Severe cramping and swelling in my right leg and ankle. 3/9/21 Work clinic advised to seek medical attention 3/9/21 Hospital Emergency Room Diagnosis: Deep Vein Thrombosis (DVT)- Blood Clot 3/10/21 Thrombectomy Surgery & Released 3/11/21 Swelling in right leg and ankle Returned 3/12-16/21 Readmitted - Blood Clot returned Currently under several doctors care.
63 2021-04-13 facial paralysis, bell's palsy Bell's palsy. Developed L facial droop on 3/29/2021; COVID vaccines on 1/16/2021 and 2/8/2021.
63 2021-04-15 weakness Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine sit... Read more
Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine site which is becoming bigger. Also, have a canker side in my throat-I send to get them as a child, in my throat. Also, broke my knee cap 2 years ago and it had become painful
63 2021-04-17 pain in extremity has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart ra... Read more
has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart rates; She'll have a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night.; When probing for specific event information she reports it's kind of like she coughs a little more and she is a little more short of breath and it's happening more often; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 63 years, via an unspecified route of administration on 27Mar2021 04:06 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history included asthma, hysterectomy, dark chocolate or red dye (she starts coughing and has an allergic reaction and shortness of breath), bursitis (in her right). The patient's concomitant medications were not reported. The patient previously took penicillin, experienced allergy and had really ad hives (several years ago) she was given a cream to put on. She had to get another medication and she doesn't remember the name. That medication made her dizzy and she couldn't even get out of bed so they had to half the dosage. When she had her hysterectomy she learned she couldn't take any types of "cillins" medications. The patient had been watching her heart rate with a device and since getting the Covid 19 vaccine she's noticed her heartrate was always higher than it normally is. Her heartrate was going crazy, the device was not recording right. She reports that for the last 2 days the device has been telling her she has possible atrial fibrillation. This is worrying her. She doesn't feel anything different. She was usually hyper. Her resting heartrate was higher. Normally her resting heartrate was in the 80s (beats per minute) Now it's going up to the 90s (beats per minute) then her heartrate drops to 40 something (beats per minute) Then the device said her heartrate was 118 and 107 and she's not even doing anything. She hasn't even worked out yet. She doesn't like to take medicine. Medications don't work out with her. She had a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night. It was reported that she feels fine. She has no other symptoms. She's been reporting online. Clarified she's reporting online through the V check through the CDC. She's been trying to get the Covid 19 vaccine forever. She did research on all the Covid vaccines and she felt more confident with the Pfizer Covid 19 vaccine. Her daughter was against the Covid 19 vaccine. Her daughter thinks the vaccine was just going to kill her. She reports she was healthy and she works out 6 days a week. She recently tried to get a CT scan for her heart. Her husband's cardiologist recommended her husband have a CT scan of his heart and she decided she needed a CT scan too. She's also watching her heartrate on her watch. Her husband's heartrate is completely normal and stable on the device so she knows the device isn't messed up. It was also reported that the device will tell her she has too much muscle movement and she's standing completely still. Then she'll get the device to record her heart rhythm and it goes sporadic. The device tells her 90 beats per minute at resting then over 100 beats per minute. Her heartrate on the device was going up and down a lot. When she's been watching the device record her heart, it looks like it's going crazy. Her heartrate goes way up and way down like in the 40s (beats per minute) She noticed when her heartrate is in the 40s (beats per minute) and she's never had her heartrate go down that far, it's really really weird. She thinks maybe she'll get back to normal. She keeps watching hear heartrate. She reports she noticed her heartrate right away on Saturday evening after she received the Covid 19 vaccine. Her heartrate was higher than normal for resting, it was in the 90s (beats per minute). Her resting heartrate is usually in the 60-80s (beats per minute) and it was the in 90s. Now the device says possible atrial fibrillation. It was further reported that she received the Covid 19 vaccine in her left arm because she has bursitis in her right. If she hit her arm the second day after the Covid 19 vaccine, her arm would hurt. Her arm felt better the next day. She clarifies, on Sunday, 28Mar2021, she noticed her arm felt like a bruise and that was it. Then the next day on Monday, 29Mar2021, the feeling was gone. She didn't have any redness. The outcome of the events her arm felt like a bruise and arm would get hurt was recovered on 29Mar2021, irregular heart rates, dyspnea, cough was not recovered and unknown outcome for has possible atrial fibrillation. Information on the lot/batch number has been requested.
63 2021-04-18 weakness Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third... Read more
Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; This is a spontaneous report from a non-contactable consumer (Patient). A 63-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), dose 1st via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:00 as single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On 01Apr2021 11:15, the patient experienced Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack. The patient had other medications in two weeks of vaccination. Patient did not took any treatment for adverse event. Patient did not had covid prior vaccination and not tested for covid post vaccination. She did not have any Known allergies and had other medical history. No follow up needed. No further information is excepted.
63 2021-04-18 pain in extremity intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up... Read more
intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up; rush of pressure to back of head and the lower part of head; Headache; dizzy/Dizziness/light headed; out of body experience like floating; my arm started to really hurt/Sore Arm; sore to touch; cloudy and pressure in her ears/Ear Pressure; vertigo issues; vestibular migraines; patient can't walk; tunnel vision; eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Left Arm on 01Apr2021 about 13:30-14:00 pm (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hashimoto's disease, Diagnosed 13 Years ago, patient was allergic to penicillin and Avalox (anaphylactic and I am sensitive to medications). Don't know if this happened when she got Hashimoto's, Thyroid, ongoing Vestibular Issues Started 5 years ago. States one doctor thinks it is her bad neck. States when she got old things shifted and changed. One ENT said she has neuritis, where something hit her ear nerve in right ear. States hence that was what the acyclovir was for, when she feels an earache coming on, she takes acyclovir. No previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). AEs following prior vaccinations: None; reported she hadn't had any flu vaccines in years because of the ingredients. States because of her Hashimotos because of everything with her health it was not conducive. Last one was 2014. Concomitant medications included guaifenesin (MUCINEX) taken for hypersensitivity from an unspecified start date and ongoing; fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine sodium (LEVOXYL) taken for thyroid disorder from an unspecified start date and ongoing; azelastine hydrochloride (AZELASTINE HYDROCHLORIDE) taken for hypersensitivity from an unspecified start date and ongoing; aciclovir (ACYCLOVIR ACTAVIS) taken for ear pain from Mar2021 to an unspecified stop date; naltrexone (NALTREXONE) taken for autoimmune thyroiditis from an unspecified start date and ongoing; alprazolam (XANAX) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for an unspecified indication from an unspecified start date and ongoing; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; curcumin (TURMERIC MERIVA) taken for an unspecified indication from an unspecified start date and ongoing; 7-keto-dehydroepiandrosterone (7 KETO DHEA) taken for an unspecified indication, start and stop date were not reported; ferritin (FERRITIN) taken for an unspecified indication from an unspecified start date and ongoing; boric acid, zinc sulfate (OPTIZINC) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; lactobacillus reuteri (PROBIOTICA) taken for an unspecified indication from an unspecified start date and ongoing; calcium saccharate (CALCIUM D GLUCARATE) taken for an unspecified indication from an unspecified start date and ongoing; berberine hydrochloride, coptis chinensis, glycyrrhiza uralensis, mahonia aquifolium, phellodendron chinense, rheum officinale, scutellaria baicalensis, zingiber officinale (CANDIBACTIN BR) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication from an unspecified start date and ongoing; alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) taken for an unspecified indication from an unspecified start date and ongoing; pancreatin enzymatic hydrolysate (PANCREATIN ENZYMATIC HYDROLYSATE) taken for an unspecified indication from an unspecified start date and ongoing; levoglutamide (L GLUTAMINE) taken for an unspecified indication from an unspecified start date and ongoing; betaine hcl (BETAINE HCL) taken for an unspecified indication, start and stop date were not reported, Bio Identical Hormone Cream taken for an unspecified indication, start and stop date were not reported. On 01APR2021, she could feel rush of pressure to back of head, tunnel vision, cloudy and pressure in her ears and was dizzy. Hx of Hashimoto's - autoimmune disorder, vestibular issue, concerns with getting the second one (dose). Read about adverse reactions and dizziness was on the list of severe reactions. The instant, within a minute, patient could feel this happening to her, she instantly could feel she becoming dizzy, light headed, out of body experience like floating. (didn't mention this in report) felt like walking on air. While sitting and chit chatting with other people to distract myself. Patient didn't have any anxiety. She will admit she was reluctant to get the vaccine because of my health problems. She was more concerned, she instantly got a headache with the pressure, when she was leaving, she felt her eyes feel weird, almost like an allergy issue, burning, not quite burning either. Kind of like a burning, not quite like a burning, felt like when you walk into the wind that has lots of pollen, that feeling. She didn't walk out side, she was inside when this happened, the pressure was already starting, no headache in front of head, it was in back of my skull, at top of her neck and pressure within the ears and ache and pressure on back of her head. Not dizzy, not like when you are in the hospital and they give she something and patient can't walk, or where you tried to stand and you couldn't , it was more like light headed, like walking on air like. It lasted all yesterday. As the night progressed by 10PM or 11PM her arm started to really hurt, patient took Tylenol and went to bed, took Xanax as she did and slept, woke up fine. This morning it felt like she wanted to have a headache but haven't had it since. It's almost like patient had intracranial pressure, because she had these conditions, so she read a lot. Investigation Assessment was No. States she is calling to report a potentially strange side effect. She states as soon as she got the injection, approximately within one-two minutes, she could feel a rush to the back of her head and the lower part of her head which then made her feel like she had somewhat of her vision clouded, like a tunnel vision. Clarifies her vision was clouded on the sides but she could see forward. Caller states that she was not dizzy like falling over and she does have vestibular migraines and vertigo issues, but she had that feeling of dizziness and when she got up and walked, it felt like she was walking on a cloud. Clarifies she felt a heavy pressure in the back of her head. States as soon as the injection was over, she could feel it. States she is concerned regarding the second dose because of her autoimmune and vestibular conditions. She states is caused immediate pressure in her ears. States that could've affected her and put her into a migraine, she doesn't know. States a friend said jeez you should report that and she read more on the list of side effects and saw something about an allergic reaction and dizziness, and she did have some sort of adverse reaction. States she doesn't know and it is concerning to her. States she is doing fine today, other than a little headache that comes and comes. States it was bizarre with the clouded, not cloudy, but tunnel vision. States she does not want to release any medical records; she declines for now to provide. She states CVS administered it, not her doctor. States she is going to discuss it with him. States she doesn't want to have a worse reaction with the second dose. Caller states a headache is a headache but the pressure she felt within one minute and continuing it concerns her on the second one with the larger dose. States she is also concerned with the second dose if dizziness is a severe allergic reaction, not saying she fell over and wiped out. Patient wondering if that was an allergic reaction. States as the evening went on and she took Tylenol, it improved. States the dizziness improved as the night went on but had a bizarre feeling when she went to bed. States her arm was sore in the evening and is still sore to the touch. Clarifies that her eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something. States it was not like a tired and burning feeling, states she can't explain it but something felt like had an allergy type situation if she has a problem with seasonal allergies. Treatment included took Tylenol. States when someone has an autoimmune issue they have a lot of issues regarding the stomach and take a lot of vitamins and supplements. Caller states she wants to report she has a lot of food sensitivities and environmental sensitivities because of her Hashimotos. States anything can set off an immune response. States what happens with that is she would get on her face, angioedema near her ears and the gland secretes and the passage way swells up. States she takes Pepcid AC to treat it. States this did not happen with her first vaccine. States she was very hesitant on taking the vaccine because knows she has these issues and she didn't want to have adverse reactions. States that her reaction to the first vaccine potentially concerns her for the second dose. States going to speak with the medical information department is a good idea. States the location she received her vaccine was very busy. States they did a nice and good job on getting people in. States the girl administering it did good, but she didn't mention unless you knew you had to wait 15 minutes due to possible adverse reactions, they didn't really check on people. States she just had to do whatever and she didn't know whether or not to report it then because she was not in distress. States she thought she just has to get home and drove 30 miles. All events (AEs) did not require a visit to Emergency Room nor Physician Office. The events of Tunnel vision, rush of pressure to back of head and the lower part of head, Headache, dizzy/Dizziness/light headed, cloudy and pressure in her ears/Ear Pressure, was recovered on 01Apr2021, of my arm started to really hurt/Sore Arm; sore to touch was not recovered, of other events was unknown.
63 2021-04-24 cold extremities, pain in extremity, facial pain Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; ... Read more
Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.
63 2021-04-24 pain in extremity Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make... Read more
Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands; pain in arm; right ear & head pains; right ear & head pains; This is a spontaneous report from a contactable nurse, the patient, and based on information received by Pfizer from Abbvie Pharmacovigilance (Mfr. Control No.: 21K-163-3848385-00). A 63-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6207) intramuscular in the right arm on 18Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization; adalimumab (HUMIRA) solution for injection, subcutaneously, from an unspecified date at an unspecified dose and frequency for rheumatoid arthritis (RA). Medical history included polymyalgia rheumatica (PMR), RA, hypothyroidism, anemia. The patient had no known allergies. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included prednisone, levothyroxine sodium (SYNTHROID), folic acid, calcium carbonate (CAL). The patient did not receive any other vaccinations within 4 weeks of BNT162B2. On 18Mar2021 (within 4 hours of the vaccination), the patient experienced a rheumatoid arthritis flare up. The clinical course was as follows: on 18Mar2021 at 15:00, the patient experienced pain in elbow and finger pain (like trigger finger of both hands). On Mar2021 (within 24 hours), all fingers were involved, the patient's grip strength was decreased (she could not make a fist or grasp or grip/ inability to grip or grasp with her hands) and experienced left wrist pain. On Mar2021 (within 48 hours), the patient experienced finger edema, was still unable to make fist or grasp, experienced painful shooting pains up inner arms, right ear & head pains. The patient increased the prednisone dose to 4 mg daily as treatment for the events. On 21Mar2021 at 11:00 (72 hours after vaccination), the patient continued to experience bilateral arm pains, slight hand grips but could not lift, new right knee and right outer foot pains. On 21Mar2021 (94 hours after vaccination), there was less arm pain and finger edema, continued right ear/head pains. The patient saw the primary physician, there was no ear infection and the physician agreed with the prednisone increase. The physician felt the patient should not take the second vaccine dose and alerted the rheumatologist. On 22Mar2021 (116 hours after vaccination), the patient was able to lift and grasp with both hands, had less ear and arm pain. Since the vaccination, the patient was not tested for COVID-19. The action taken with adalimumab in response to the events was unknown. The reporter's causality for the events trigger finger, inability to grip or grasp with her hands, severe flare of RA symptoms 4 hours post vaccine, pain in arms and elbows, pain in ears was not provided. The clinical outcome of rheumatoid arthritis flare up, trigger finger, "grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands", pain in arm, right ear & head pains was resolving; while of pain in elbow was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the RA flare and other events. The reported events may likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
63 2021-04-24 weakness, numbness, tingling, pain in extremity some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headach... Read more
some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-04-28 slurring, cold extremities, pain in extremity Stroke; MRI showed Pontine Stroke; left arm was weak; her writing looked like a baby's scribble/she ... Read more
Stroke; MRI showed Pontine Stroke; left arm was weak; her writing looked like a baby's scribble/she cannot write or type; arm was sore; she sounded different; they said her speech sounded slurred; was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4; was not able to walk at first; her arm was cold; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 24Feb2021 08:00 (at the age of 63-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included high blood pressure that was diagnosed 2-3 years ago, diabetes; she was prediabetic, heart;cholesterol has been high for about 30 years; since she was in her 30s; all from an unknown date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 02Feb2021 (at the age of 63-years-old) for covid-19 immunization. The patient had no prior vaccination in four weeks. Concomitant medications included rosuvastatin taken for blood cholesterol and takes 20mg once a day prior to stroke and in the hospital they increased it to 40mg once a day and ongoing; ramipril taken for blood pressure and she was prescribed with this medication for a while prior to her stroke. It was discontinued in the hospital. Stated that she did not take it everyday because she was allergic to it; and sitagliptin (JANUVIA [SITAGLIPTIN]) taken for diabetes from an unspecified start date and ongoing and stated that she has been taking for quite a while. On 24Feb2021 she had her second shot. She said that everything was fine that morning; that afternoon her arm was sore. Stated she thought nothing of it. That evening she entertained guest. They were saying she sounded different; they said her speech sounded slurred. She had gotten her vaccine at around 08:00. Again, she didn't think anything about her speech. On 25Feb2021, she got up and did some laundry going up and down the steps. Stated that it was difficult because her arm was still sore. She cleaned the house. At around 15:30 she was doing bills and noticed that her writing looked like a baby's scribble. On 26Feb2021, she noticed that her left arm was weak and was told by her doctor to go to the Emergency Room where they told her she had a stroke. She added that it seemed like her arm was cold for a number of weeks. Stated she was the type to wear t-shirts in the winter because she was always hot. During those weeks she was wearing heavy clothes and was under blankets. She was just now starting to feel more like herself and not so cold all the time. The patient was unable to recall time frame when this symptom began. The events did require a visit to emergency room and physician office. The patient was hospitalized for 4 days due to the events from 26Feb2021 to 01Mar2021. During hospitalization, the patient saw a cardiologist, neurologist, her primary care provider, and the hospitalists who all said it was very suspicious that her stroke happened right after her vaccine. Before she got her second vaccine, she was doing embroidery and everything she normally does; nothing was wrong. They did a CAT Scan that showed nothing. Then the MRI of the brain showed a Pontine Stroke on 26Feb2021. Cardiologist put a heart monitor on her and could not find anything. They were looking for A-Fib or something like that when she was on the heart monitor in the hospital; but it never showed anything irregular. She had a loop recorder implanted to monitor her heart and they haven't found anything wrong on it. She had heart tests, carotid artery tests, ultrasound of her heart and nothing was found on those tests. They pretty much told her in the hospital that they couldn't find a reason for her stroke. She kept asking about the vaccine. They did not rule it out as a cause, but they also did not say it was the cause. All the doctors said they could not pin her stroke on the vaccine. They stated it was suspicious and that they had seen 2-3 other patients with a similar situation. One of the doctor's told her he would not rule it out. They did an ultrasound of her carotids and heart and did not find anything on those tests that would have caused her stroke. She was having lasting effects related to her stroke. Her arm was still sore at times, stated it was a different kind of sore and could be related to all the therapy she does now. The lingering effects after stroke was reported as she was not able to walk at first. She's been doing therapy focused on her left side. Stated that her left side was the dominant side and she cannot write or type. She couldn't do the report online due to the difficulty with typing. She wanted to make sure this was reported. The patient has been doing therapy for 7 weeks, twice a day; and stated she likely still has months more of therapy to try and get her left side back to normal. She said that simple daily duties are difficult. The patient also stated that she was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4. She doesn't know what made it go up. Then states she doesn't know if the vaccine made it go up or not. She has a follow up with the neurologist soon. The patient also reported medications she has been taking since her stroke and hospitalization; but not prior to her vaccine which included Amlodipine-Benazepril: 5-20mg once a day and Aspirin: 325mg once a day. The patient stated that stroke and heart problems do not run in her family. The outcome of the events was unknown.
64 2021-01-02 facial paralysis Right side of lip started swelling about 7:30 pm on 12/31/2020. Took Benadryl and picked up Epi pen... Read more
Right side of lip started swelling about 7:30 pm on 12/31/2020. Took Benadryl and picked up Epi pen at pharmacy. Swelling increased overnight up into right cheek and jaw. Right side eye and cheek and mouth drooping with a crooked smile. On 01/02/2020 started itching from up under right ear down towards neck with redness and hives. Got RX from pharmacy for Prednisone and am currently taking that
64 2021-01-03 numbness By evening of the same day I read the vaccine my right side got numb my cheek and eye hurt to the to... Read more
By evening of the same day I read the vaccine my right side got numb my cheek and eye hurt to the touch, my eye socket was very sore, like if I was getting Bells Palsy. I took Vitamin B12 sublingual and went to bed and the next day it was still sore but I took the vitamins again and later on it subsided. By the first of the month those symptoms were a lot less and now I am fine.
64 2021-01-05 weakness, pain in extremity I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness o... Read more
I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness or swelling at the site. I couldnt lie on my left arm at all that night. By 11pm I also experienced headache, sinus drainage, sore throat, body aches, taste and smell were off, upset stomach, queezy stomach but no nausea or vomiting, very weak , dry mouth, fever at 99.2 then 98.6, chills, lots of chills. The covid hotline at my work told me I had a moderate reaction to the vaccine. Treatment was rest and tylenol which didn't alleviate any symptoms whatsoever. I had all these symptoms til Jan 6th at 4am. At 4am all the symptoms left and have not returned.
64 2021-01-05 pain in extremity, feeling cold Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hiv... Read more
Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hives/welts came up on right ear and behind neck/welts under buttocks and behind knees, welts were large and red; Slight chills; Tenderness in injection arm; was just a little cold; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PAA156571), via an unspecified route of administration in left deltoid on 28Dec2020 10:00 at 0.3 mL single for covid-19 immunization; sulfamethoxazole, trimethoprim (BACTRIM DS), at twice a day for 10 days for perineal cyst. The patient was on her last day of sulfamethoxazole, trimethoprim on the day she got the COVID-19 vaccine (28Dec2020). Medical history included perineal cyst, COVID-19 in Apr2020 with no problem, only had a cough. Husband had COVID-19 and had loss of taste and smell, had fever, but he was not serious. Both her and her husband got tested for antibodies and were positive. Family medical history was none. The patient had unspecified flu vaccine (Lot: UJ428AB) on 18Dec2020 injected in left deltoid in two weeks prior to COVID-19 Vaccine. Checked with three different people who stated the Flu vaccine would not interfere with COVID-19 Vaccine. Checked with two pharmacists who stated Bactrim DS would not affect her taking the COVID-19 Vaccine. She received COVID-19 Vaccine through her work in a nursing home. There were no additional vaccines administered on same date of Pfizer suspect. On 28Dec2020 about 7 to 8 hours after vaccination, patient had slight chills and tenderness in her arm: was just a little cold. Thirty-six hours after injection, midnight on 29Dec2020, her scalp itched like crazy, broke out in hives. On 30Dec2020, rash developed on both lateral sides of her breast, welts came up on right ear and behind neck. On 31Dec2020, welts under buttocks and behind knees, welts were large and red. Rash on lateral breasts: felt a bit of itching. The patient had blotchy rashes, rash up in her hair above her neck and back of ear, had intense itching; which subsided. It was a little pink on her chest, little itching on her head. Her ear was better. Symptoms were most mild because she was still able to function. Clarified as not serious. The patient was taking diphenhydramine (BENADRYL, Lot: SMF011, Exp: May2022) at 25mg every 3.5 to 4 hours, cortisone cream 10 Maximum Strength (Lot: 20K434, Exp: Sep2023) for rash and welts; and doing tepid soaks. It was tolerable and faded. Rash had subsided, but was a little red. Her greatest concern was what to do in regards to the second dose in three weeks. The reporter considered events were related with COVID-19 Vaccine. The action taken in response to the events for sulfamethoxazole, trimethoprim was unknown. The outcome of events was unknown.
64 2021-01-05 tenderness a slight chill the first night; slight tenderness to arms; This is a spontaneous report from a conta... Read more
a slight chill the first night; slight tenderness to arms; This is a spontaneous report from a contactable nurse reported for her identical twin sister. A 64-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included unspecified flu vaccine on 18Dec2020. The patient experienced a slight chill the first night and slight tenderness to arms on 28Dec2020 with outcome of unknown. Information about Lot/Batch number requested.
64 2021-01-06 weakness At twelve hours post injection I awoke with severe chills even though I did not have a temperature. ... Read more
At twelve hours post injection I awoke with severe chills even though I did not have a temperature. After taking 1000 mg of Tylenol the chills past in approximately an hour. The rest of the day I had extreme fatigue, headache, lethargy, and loss of appetite. By the next morning I still had the fatigue and weakness which improved gradually over the next 12 hours.
64 2021-01-06 discomfort Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and ... Read more
Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and pains. Slight dizziness. The next day, all symptoms gone. Injection site/sore arm for 3 days.
64 2021-01-07 hot flush Sever hot flash raising heart rate high blood pressure 192/112 the paramedics stay with me for an... Read more
Sever hot flash raising heart rate high blood pressure 192/112 the paramedics stay with me for an 1hr in a half I had high blood pressure it started 20min after the vaccine
64 2021-01-08 pain in extremity Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should ... Read more
Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should go home or be reported. First shot had a sore arm & a bit of a cold for a few hours and back to work. This time has sore arm and is more tired than usual. 98.7 F No cough, HA, N/V. No medications taken for s/e.
64 2021-01-08 flushing Flushing Narrative: Flushing 10 minutes after vaccine administration
64 2021-01-08 pain in extremity headache, sore arm, fever, body aches, tiredness
64 2021-01-09 tremor, feeling cold, feeling hot About 24 hours after I got my injection I began to feel cold. I am by nature always cold but within... Read more
About 24 hours after I got my injection I began to feel cold. I am by nature always cold but within 30 minutes I began to shiver. This intensified and I got to the point I was shaking hard and so cold. I had also had a headache all day but that is not unusual for me as I frequently have sinus headaches that can last all day. I took my temperature which was 98.3 but I took Tylenol anyway realizing I was likely having a vaccine reaction. I got into bed under my electric blanket. Ninety minutes later I had finally warmed up. In fact my feet and hands felt like they were on fire. I rechecked my temperature and it was up to 100.9. I peeled off my numerous clothing layers and I actually felt better since the chilling had stopped. I ate some dinner and watched TV and went to be around 11pm. I slept fitfully which is normal for me. As the night wore on I began chilling again. I got up sometime around 5am and took more Tylenol. If I remember my temperature was around 100.1. I slept several hours and woke up feeling ?back to normal?.
64 2021-01-09 pain in extremity Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu l... Read more
Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu like feeling
64 2021-01-09 pain in extremity Fever (oral temp 100.5) Body Aches Chills Headache Fatigue Right arm pain
64 2021-01-10 hot flush 20 min after injection; BP 192/112, hot flushing, dizziness, blurred Lt eye. Hypertension continue... Read more
20 min after injection; BP 192/112, hot flushing, dizziness, blurred Lt eye. Hypertension continued for 1.5 hrs, however hot flush, dizziness and blurred vision Lt eye resolved.
64 2021-01-10 flushing As per RN documentation, Pt with hx of anaphylaxis with the 4th infusion dose of Rotuxin a couple ye... Read more
As per RN documentation, Pt with hx of anaphylaxis with the 4th infusion dose of Rotuxin a couple years ago. PCP discussed benefit to prevent complications of COVID vaccine outweighs risk to get COVID vaccine. Discussed this as well with patient. She agrees to get the vaccine.   I stayed with the RN and patient for 30 minutes post vaccination and she had no symptoms other than BP and Pulse elevated further to 150s/90s. P upper 80s. She was transitioned to anther office with plan to continue observation for another 15 mins and recheck her BP.   About 45-50 mins post vaccine, she reported her lower arms and right side of her neck felt swollen but had no SOB or mouth swelling or itching. She was talking in normal sentences. Her face became more flushed as well as the posterior aspect of her forearms and she said the neck felt more swollen. Epi Pen was administered at 8:40 am and EMS was contacted. Her BP was 160/100, pulse ox 96%, RR 26, Pulse 88.   Transferred to ED.
64 2021-01-10 feeling hot At 15 minutes developed abdominal pain, facial redness, heat and burning. Lasted 2 hours and self ab... Read more
At 15 minutes developed abdominal pain, facial redness, heat and burning. Lasted 2 hours and self abated. On day 4 developed new onset food and flower allergies which lasted until day 10. These were lip tingling, eye swelling and redness and burning.
64 2021-01-10 pain in extremity, tremor Patient had the vaccine on Friday (2:30pm) and was fine. Saturday then she had a sore arm. She went... Read more
Patient had the vaccine on Friday (2:30pm) and was fine. Saturday then she had a sore arm. She went to work and was fine (10 hour shift). She had Gammagard around 6pm and then the infusion was fine and went on as normal (a little burning at the beginning), then chills at the end (not unheard of). An hour later she went to sleep since not feeling 100%. She woke up with severe chills, headache, body aches all over, She has bad chills and is shaky. She went home and no fever. Her eyes are kind of burning. She has a call with her doctor today.
64 2021-01-10 pain in extremity blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot;... Read more
blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-01-11 tremor, pain in extremity 10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hip... Read more
10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hips & legs. Couldnt stand up. 24hs Later symptoms gone.
64 2021-01-11 pain in extremity Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including finger... Read more
Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain
64 2021-01-11 burning sensation I developed a headache, burning of my face and upper gums 45-60 minutes after the vaccine. As the ... Read more
I developed a headache, burning of my face and upper gums 45-60 minutes after the vaccine. As the day went on I developed slight swelling of my upper lip. The burning of my face lasted until the following day but then would come and go. The swelling of my upper lips lasted 4 days. Last Thursday 1/7/2021 my face was burning and lasted the day.
64 2021-01-11 feeling cold Recipient reported heartburn sensation, chills, fatigue.
64 2021-01-11 pain in extremity left arm: pain, swelling, redness, warmth, itching: after 5 days: still a bump at injection site (b... Read more
left arm: pain, swelling, redness, warmth, itching: after 5 days: still a bump at injection site (but smaller than in previous days), still warmth (but less than in previous days), redness has become pinkness in a smaller area, also less itching, minor pain at touch puffy eyelids and inflammation but this may have been blepharitis which I have had in the past
64 2021-01-12 pain in extremity Arm pain; Nausea; lightheadedness; This is a spontaneous report from a contactable healthcare profes... Read more
Arm pain; Nausea; lightheadedness; This is a spontaneous report from a contactable healthcare professional (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm in Jan2021 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included hypothyroidism. It was reported that the patient had allergies with sulfa and trimethoprim / sulfamethoxazole (BACTRIM). Concomitant medications included levothyroxine sodium (SYNTHYROID), ergocalciferol (VIT D), levocetirizine dihydrochloride (XYZAL). It was stated that the patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. In Jan2021, the patient experienced arm pain after 10 hours of getting the vaccine. It was also reported that nausea and lightheadedness the following day. No treatment received for the adverse events. The patient recovered from the events in Jan2021 (reported as feeling passed after 2hrs) Information on the lot/batch number has been requested.
64 2021-01-12 pain in extremity Arm soreness @ 11pm 1/11/2021; continual headache starting @ 2am 1/12/2021 accompanied by chills,... Read more
Arm soreness @ 11pm 1/11/2021; continual headache starting @ 2am 1/12/2021 accompanied by chills, low grade temp of 99.7 , skin hurt all over & generally feeling unwell. These symptoms continued until 11 pm 1/12/2021. Took Tylenol, wet to bed & woke up 1/13/2021 without symptoms.
64 2021-01-12 night sweats Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to... Read more
Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to work and had to leave. Patient reports night sweats, severe fatigue. Patient says the night sweats is the reason she is calling.
64 2021-01-12 pain in extremity Patient states her arm is sore and red at the injection site. It started a week after she received ... Read more
Patient states her arm is sore and red at the injection site. It started a week after she received the vaccine. She has been advised by her physician to ice the affected area and take Tylenol for any pain.
64 2021-01-12 pain in extremity, tingling, numbness Received Covid 19 vaccine on 1/6/2021 Left arm. Immediately had left arm pain and next day had numb... Read more
Received Covid 19 vaccine on 1/6/2021 Left arm. Immediately had left arm pain and next day had numbness and tingling,along with rash upper chest and neck.
64 2021-01-12 nerve pain, pain in extremity Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle ... Read more
Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle of night with severe bilateral leg pain, similar to sciatica, painful to get out of bed and walk, similar to Charlie Horse. She took Tylenol and laid around most of the day 1/11/21. Pain in right leg stopped in evening on 1/11/21, however pain continues in left leg. Nerve pain in left leg is still continuing from left gluteal muscle to inner thigh above knee cap. She declined occupational health follow-up and will self-manage at home. Pfizer-BioNTech COVID- 19 Vaccine
64 2021-01-12 tremor, feeling cold awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu... Read more
awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu-like sx lasted for one day; fever resolved by this am 1/13
64 2021-01-12 flushing felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous repor... Read more
felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous report from a contactable other HCP (patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided) via an unspecified route of administration (vaccination location: left arm) on 06Jan2021 09:30 at SINGLE DOSE for COVID-19 immunisation. Medical history was reported as 'none'. It was also reported that patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, and prior to vaccination, the patient was not diagnosed with COVID. The patient has no allergies to medications, food, or other products (no known allergies). The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899; expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 18Dec2020 18:00 at SINGLE DOSE for COVID-19 immunisation. It was reported that patient received second dose of Pfizer Covid vaccine on 06Jan2021 at 09:30 am. One hour after the 2nd dose (10:30 am), patient experienced dull occipital headache. Patient took paracetamol (TYLENOL). At 10:45 am, patient felt flushed. The nurse took patient's vital signs and noted no fever, normal heart rate and respiratory rate. BP elevated 226/97 (reported at 10:30, no unit provided; normal BP: 130's/80's). At 12:45, patient was taken to ED. CT scan and lab work were reported as all normal. BP continues to be elevated. Amlodipine (NORVASC) 10 mg was given at 17:00. BP slowly came down. Twenty-four hours later, BP was normal at 137/72 (no unit provided). No additional medication taken. It was reported that patient continues to have dull headache. No arm soreness or other symptoms. It was also reported that since the vaccination, the patient has not been tested for COVID-19. Outcome of the events 'BP elevated 226/97' and 'felt flushed' was recovering, outcome of the event 'dull occipital headache/dull headache' was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, the Company considers the reported event blood pressure increased is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-01-13 flushing 45 min after injection face became red and flushed and headache began, redness left in about 4 hour... Read more
45 min after injection face became red and flushed and headache began, redness left in about 4 hours, headache still remains 24 hours later but mild. joints ache for 24 hours and neck slightly stiff after about 12 hours
64 2021-01-13 pain in extremity, feeling hot, facial pain Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion;... Read more
Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion; chest tightness by day 3- increased swelling of arm with redness; hot to touch; increased pain radiating to under arm.
64 2021-01-13 feeling cold Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 sof... Read more
Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 soft formed in 9 hours) resolved about 30 hours from onset.
64 2021-01-14 migraine Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive saliv... Read more
Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive salivation with nausea, lightheadedness, she has a h/o migraines headaches and was incapacitated for 24 hours, Employee she was treated and sent home by end of her scheduled shift
64 2021-01-14 pain in extremity First shot very sore arm; This is a spontaneous report from a contactable other healthcare professio... Read more
First shot very sore arm; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for herself). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EH9899, expiry date not reported), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN), CKD (Chronic kidney disease), and had known allergies to bee stings. The patient was not pregnant at the time of the vaccination. The patient had no Covid prior vaccination. Unspecified concomitant medications (reported as "lots") were taken within two weeks of vaccination. The patient previously took ibuprofen and experienced allergies. The vaccination was administered in the hospital. The patient experienced from the first shot, very sore arm on an unspecified date. Arm still sore at 60 hours. The event was reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatments received in response to the event reported. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event sore arm was reported as recovering.
64 2021-01-14 seizure, unresponsive to stimuli Observed in her room having seizure activity and unresponsive to stimuli. BP of 200/120, oxygen leve... Read more
Observed in her room having seizure activity and unresponsive to stimuli. BP of 200/120, oxygen level dropped to 86%, HR was 116. She was transferred from Hospital A and later transferred to Hospital B and placed on a ventilator. This remains her current status
64 2021-01-14 weakness a few hrs. after receiving the vaccine patient had swelling to bilateral hands and feet. patient als... Read more
a few hrs. after receiving the vaccine patient had swelling to bilateral hands and feet. patient also developed weakness, fatigue and had chills unknown if she had fever Patient was seen by family MD after a few days of swelling
64 2021-01-14 pain in extremity, feeling cold almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in he... Read more
almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in her mouth, white tongue; felt a little cold; legs were sore; headache; Sore arms; severe sore throats; back ache; low grade temp/Low grade fever; coughing; body aches/ whole body was achy; it was sore to swallow; lethargy; This is a spontaneous report from a contactable consumer reporting for self. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EL1284, Expiry Apr2021, intramuscularly on 30Dec2020 02:15 (Dose 1), right arm as a single dose (age at vaccination 64 years old) for COVID-19 immunization. Medical history included allergy (usually in the fall she has allergy problems). Her age is considered high risk, works in medical profession (Surgical Tech). Concomitant medication included levocetirizine (Walgreen's generic) 5mg, tablet, by mouth, at night for allergy. The patient had the first dose of the vaccine last 30Dec(2020) and after 2 days (on 01Jan2021) she developed symptoms: Sore arms, severe sore throats, back ache/ back was sore, temperature was up / low grade temp (never high), coughing, body aches. Her back and her legs were sore. Her whole body was achy. It was "like flu-ish kinda." She also had a headache. She started getting the sore throat and headache on 01Jan2021, and she felt a little cold on 02Jan2021. On 02Jan(2021), her first temperature was 100.5 degrees Fahrenheit. She states she had everything except for the GI issues. Around 02Jan(2021) or 03Jan(2021), her symptoms were progressively getting worse. She was told to get COVID tested. There were three exposures since Christmas Eve. So, she went and got a rapid COVID test (04Jan2021) and it came back negative. They also sent out a test that day. She was also tested for Strep (04Jan2021) too because her throat was so sore. It was almost like she had like thrush along with it. She states it was almost like a thrush because she had like a white tongue (onset 03Jan2021). Her throat was so sore, but it was a different kind of sore throat compared to a sore throat she has had before. She explains where the nasopharynx was at the top, it's almost like it was sore from there. It was sore to swallow, it was "a bizarre sore throat." She clarified she noticed the "thrushy" part of her throat around 03Jan2021. The strep test ended up being negative but she believes she had thrush because she was given medication and the medication was clearing that up. However, she still had the symptoms. Because her symptoms only started a few days before, they thought she should maybe wait a couple of days and if she is not feeling any better, she should be retested (for COVID). She went back again yesterday (07Jan2021). She had another Rapid COVID test and also a flu swab and both tests came back negative. She mentions they also did another COVID test (the send out type) and she should get that back around 1pm to find out the results of that. They also did a CBC (07Jan2021) and everything was normal. Her white count was at 7. She was waiting for the 3rd COVID test result today (08Jan2021). She reported that about three days afterwards, she didn't notice the soreness in /her arm. Her throat has improved. Her fever was down to 98 degrees Fahrenheit yesterday (07Jan2021). She states she was feeling better today (08Jan2021). She commented "the lethargy, though." She emptied the dishwasher yesterday (07Jan2021) and had to sit down after emptying it. She states her symptoms have her a little worried. She recovered from the sore arms in Jan2021. The patient was recovering from the severe sore throat, back ache, low grade temp, coughing, body aches/ whole body was achy, believes she had thrush, white tongue, legs were sore, headache, and felt a little cold. The outcome of the event lethargy was not recovered. She was wondering if this was a reaction to the vaccine.
64 2021-01-15 tremor, one side paralysis shakiness, subjective feeling of tongue and throat swelling. mild tachypnea tachycardia = 80 no BP... Read more
shakiness, subjective feeling of tongue and throat swelling. mild tachypnea tachycardia = 80 no BP changes no rash no observed facial swelling or lip swelling but patient has dense right facial hemiparesis with preexisting asymmetry Epi pen administered, transferred to ED> solumedrol and Benadryl given IV and observation x 2 hours. home with oral prednisone x 5d dx "anaphylactoid reaction"
64 2021-01-16 muscle spasms I experienced excruciating pain in my middle back--it woke me from my sleep. It felt like that entir... Read more
I experienced excruciating pain in my middle back--it woke me from my sleep. It felt like that entire area was in pain. I could not been over without twinges of spasms. I could walk without problems--including up and downstairs (with extreme caution). On 1/16/21 I started taking Bayer for Body and Back pain and using Icy Hot on the area that hurt. I called my doctor's office for med for spasms and she said I need to see a doctor. I wanted to be compliant with her recommendations. The doctor suggested Extra Strength Tylenol every three hours.
64 2021-01-16 muscle spasms Saturday morning 1/16/2021, had LLQ abd pain, crampy. Has a BM and was very small. Later followed by... Read more
Saturday morning 1/16/2021, had LLQ abd pain, crampy. Has a BM and was very small. Later followed by a dime size of mucous and then later a dime size of bright red blood. No history of rectal bleeding prior. Later in the had more cramping and passed addition medium BM with blood not in stool. Noted for one day only. No idea if this is related to vaccine, but was an unusual occurrence four days after vaccine.
64 2021-01-17 discomfort After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart... Read more
After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart was pounding check my BP 150/80 laid back down. I woke up around 5pm my BP had elevated to 160 (don't remember diastolic reading) pulse rate normal limits. I informed my spouse of what was happening called 911. At the hospital checked vitals, EKG, CT Scan, Chest X-ray, Blood work and Potassium was low took 2 Potassium pills. I went back home on 12/31 returned to work did fine that day. On New Years day everything started back again discomfort went back to ER. I felt like force in my chest the doctor collected my information and I was placed on a low dose BP medication until I return to my PCP, cardiologist(stress test). I followed up with PCP via Telehealth about my BP concerns, my dosage was increased to 25 mg and due to my symptoms I was placed on leave from work 2 wks. I also have a appointment scheduled with Neurologist.
64 2021-01-17 pain in extremity Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administra... Read more
Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administration. Effects lasted for 3 days despite round the clock Tylenol dosing.
64 2021-01-17 feeling cold, pain in extremity Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. ... Read more
Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. tiredness and muscle soreness, intermittent nausea lasted for 5 days
64 2021-01-17 tingling The right side of my face (cheek) began to tingle, and the my left hand was tingling as well. This i... Read more
The right side of my face (cheek) began to tingle, and the my left hand was tingling as well. This is not normal for me. It feels like my cheek is going to sleep. So I've been rubbing it. As for my left hand, I've been opening and closing it.
64 2021-01-17 pain in extremity severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hour... Read more
severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hours; This is a spontaneous report from a contactable other Health Professional (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), via an unspecified route of administration on 07Jan2021 10:30 at single dose in right arm for covid-19 immunization. Medical history included hypertension (Htn), chronic kidney disease (CKD), the patient had known allergies to ibuprofen, bee stings. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899), on 17Dec2020 at the single dose for covid-19 immunization and experienced very sore arm. Concomitant medications the patient received within 2 weeks of vaccination reported as yes. The patient experienced severe headache, nausea, chills, sinus pain, cough, and joint pain for 24 hrs; headache and nausea continued another 12 hours. Bedridden first 24 hours. Arm still sore at 60 hours on 07Jan2021 22:00. The patient did not receive any treatments. The outcome of the events was recovering.
64 2021-01-17 pain in extremity sore left arm; This is a spontaneous report from a contactable Nurse. 64-year-old female patient rec... Read more
sore left arm; This is a spontaneous report from a contactable Nurse. 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EKS730), intramuscular (IM) on 18Dec2020 at single dose on left upper arm once for COVID-19 immunisation. There were no medical history and concomitant medications. The patient stated that she did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it was sore. The event was considered as non-serious. The outcome of the event was not recovered.
64 2021-01-17 pain in extremity very sore arm, headache, muscle aches, tiredness, chills
64 2021-01-18 seizure ER/URGENT CARE VISIT: Opening Alert charting for RETURN FROM ER (DX SEIZURE HISTORY OF). resident wa... Read more
ER/URGENT CARE VISIT: Opening Alert charting for RETURN FROM ER (DX SEIZURE HISTORY OF). resident was sent out to the ER @ 11:54 AM after having trouble breathing following her COVID vaccination. RN administered EPIPEN, emergency services was called and resident was sent out VIA ambulance
64 2021-01-18 flushing Employee felt flushed within 2 min of vaccine administration. Heart rate varied 56-68 Employee was... Read more
Employee felt flushed within 2 min of vaccine administration. Heart rate varied 56-68 Employee was observed and offered fluids and pretzels. 12:40- Bp 138/65, HR 62 100 % o2 sat. 14:00 156/80 68 100% on RA Lungs CTABL rrr no murmer. Employee was discharged to home. 1/15 Called employee for follow up and employee reported that she experienced intermittent chest pressure x approx 2 days at home and elevated BP which resolved on 1/1/21 had taken losartan 25 in the morning, thend again after COVID vaccine and again before bed. Employee was referred to contact PMD to assist in determining if secondary dose is okay to receive or if she will need cardiac eval. Employeee was referred to Oc health clinic, examined and discharged with recommendation to double losartan before next vaccine and talk to PMD before second dose of covid vaccine. Employee was also provided with the PFIZER number to report this to Pfizer.
64 2021-01-18 feeling hot Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, esp... Read more
Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, especially shoulder blades; tired/sleepy; tired/sleepy; chills; This is a spontaneous report from a contactable other HCP (patient). This 64-year-old female other HCP reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL128H), via unspecified route at right arm on 08Jan2021 07:45 AM at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included elevated blood pressure and atrial septal defect repair 2008. Concomitant medications included olmesartan medoxomil and hydrochlorothiazide. Historical vaccine included the first dose of BNT162B2 (lot# EH9899) on 18Dec2020 at age of 64 years old for COVID-19 immunization and having arm pain. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. On 08Jan2021 07:00 PM, patient experienced pain at injection site, swelling (size of her palm), warm to touch all over body and muscle aches, especially shoulder blades, very tired/sleepy with chills. No treatment was received. It was reported normal temperature for patient was 97.2 (+) or (-) 98.6. Outcome of events was recovering.
64 2021-01-18 night sweats She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COV... Read more
She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse (patient herself) reported that a 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date not reported), via an unspecified route of administration in the upper left arm on 21Dec2020 17:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing hypertension (blood pressure high). She was a former smoker, a teenage smoker. She has not smoked since the age of 19 years old. Concomitant medication included amlodipine for high blood pressure. The patient informed that she was vaccinated on 21Dec2020. On 05Jan2021, she had a positive COVID Test and she was wondering when she should have the second dose of the COVID Vaccine. She thought initially she just had a cold. She took the COVID test as a precaution. It started out with a stuffy nose. She had a congested cough, upper airway cough, nothing deep in the lungs. She had a low grade fever. It was like 99.9. It was possible it was higher, but she had taken Ibuprofen at night. She woke up soaking wet. She had sweats kind of. Her temperature however never registered a true fever if a fever was considered 100.4. She was not really having body aches any more unusual than one would have for a 64 year old. She has a very mild sore throat. Her stuffy nose had improved, it's still there slightly, but not like it was the first few days. The outcome of events was unknown.; Sender's Comments: Test positive for covid19 found 14 day following the first dose of COVID-19 vaccination, bnt162b2, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
64 2021-01-18 pain in extremity Sore arm the next morning , not bad Almost exactly 24 hrs later, fever, chills and achiness.
64 2021-01-18 pain in extremity Started feeling achy; temperature of 99.2; Sore arm; This is spontaneous report from a contactable c... Read more
Started feeling achy; temperature of 99.2; Sore arm; This is spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on 08Jan2021, temperature of 99.2 and started feeling achy on 09Jan2021. Event details: The patient received the first dose of the vaccine yesterday (08Jan2021). Yesterday night, she started with a sore arm which she expected then this afternoon (09Jan2021) she started to experience feeling achy and when she checked her temperature it was 99.2, for the sore arm last night and this morning she took Ibuprofen for treatment. The outcome of the events was unknown. Information on the batch/lot number has been requested.
64 2021-01-18 pain in extremity With my first injection I did have arm pain; This is a Follow-up spontaneous report from a contactab... Read more
With my first injection I did have arm pain; This is a Follow-up spontaneous report from a contactable Other healthcare professional. A 64-year-old female patient received BNT162B2 (Pfizer BioNTech, lot number: EH9899) first dose on 18Dec2020 07:30 AM on left arm at single dose for COVID-19 immunization. Medical history included Elevated Blood Pressure and Atrial Septal Defect repair in 2008. No Known allergies. Concomitant medications in two weeks included Olmesartan Medox/HCTZ40-12.5 MG TAB. Patient is not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. With her first injection she did have arm pain, but otherwise resumed normal activity. No treatment for the event. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the event was recovering.
64 2021-01-19 hot flush, pain in extremity FEVERISH; HOT FLASHES; MUSCLE ACHES; MILD HEADACHE; SORE ARM. TOOK ADVIL 600MG 2X DAILY
64 2021-01-19 migraine, weakness Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji ... Read more
Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji think clearly. Residual symptoms at the time of this report
64 2021-01-19 tremor, tenderness, pain in extremity On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore... Read more
On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore with a knot at injection site. Nausea and fever of 101.8-patient took Zofran=8mg. All over body aches and joint tenderness and soreness. Day 3-1/9/21-extreme fatigue and body aches, no fever or chills. Day 4 and 5 only had headaches, and on Day 6 no symptoms at all.
64 2021-01-19 tremor Pt passed out & shaking (possible seizure) shortly after injection. 911 called. Pt conscious after ... Read more
Pt passed out & shaking (possible seizure) shortly after injection. 911 called. Pt conscious after 1-2 minutes. Declined transport to ER. Monitored by RN and pharmacist for 45 min. Pt's husband drove her home when status returned to normal
64 2021-01-19 weakness Worsening diarrhea at onset followed by significant fatigue, weakness, and vibratory sensation in ar... Read more
Worsening diarrhea at onset followed by significant fatigue, weakness, and vibratory sensation in arms and legs Exam on 19 Jan 2021 revealed hyperreflexia and slightly spastic gait concerning for transverse meylitis
64 2021-01-20 numbness Patient received her first dose of the Pfizer vaccine on 1.20.2021. Patient reports chills, fatigue,... Read more
Patient received her first dose of the Pfizer vaccine on 1.20.2021. Patient reports chills, fatigue, and heel numbness. The heel numbness began the night of the injection. Patient said half of their left foot and heel felt numb. Patient states that the numbness has fully resolved by the next morning, 1.21.2021. Patient encouraged to call PCP with worrisome or bothersome problems. Patient encouraged to call back with any new changes or questions about the vaccine.
64 2021-01-20 tremor, feeling cold low grade fever, chills, aches, sensitivity to light, shakes
64 2021-01-21 discomfort R upper lip heaviness/swelling with small ulcer 30 minutes after vaccine administration
64 2021-01-22 weakness Chills, fever, headache, muscle pain, fatigue, weakness
64 2021-01-24 numbness About 3 hours before bedtime she started having decreased sensation of her left hand. Involved her ... Read more
About 3 hours before bedtime she started having decreased sensation of her left hand. Involved her entire left hand from the wrist down. By morning, her numbness had resolved entirely.
64 2021-01-24 pain in extremity Have written to Health dept no answer-they must be busy. First shot resulted in very sore upper arm ... Read more
Have written to Health dept no answer-they must be busy. First shot resulted in very sore upper arm 1.5 days, no other effects. Clean injection into deltoid muscle bulk. Second shot, injection shot extremely high above main muscle bulk of the deltoid into area of supraspinatus tendon one finger below acromial shelf. First shot, two sensations: initial puncture then injection. Shot 2 one huge painful bump met with resistance in my tissue. Also Shot 2 not one response except mild fatigue still today, but no pain in upper arm unless I pressed specifically into injection site itself. WAS THIS VARIATION IN INJECTION SITE ACCEPTABLE? WAS IT OK TO DO INJECTION SO VERY HIGH UP? Secondly, had a wonderful, professional nurse, but I question the practice of retrieving a dose for me that comprised of doses left over at bottom(s) of other vial(s). We had a new vial in the office where I was, but she left and came back with a syringe already full, saying that it was important to use up every drop. At first I agreed, but now I question this practice and just want to make sure I don't need to come back for another second dose. Are there no substrates that would settle out of the solution as the vial gets depleted of everything except only a bit of fluid left in it? Is retrieving every last drop from each vial and putting them together to make a dose acceptable practice? if not, from the Pfizer standpoint, then I should get another dose? I am a pediatric physical therapists working within 1-2 feet a children's faces at all times and transmissibility is a real issue both ways in my job. I truly do not want o become a Covid victim. please let me know if both the injection site and the method b y which my dose was put together is acceptable in the eyes of Pfizer. Thank you.
64 2021-01-24 numbness Numbness down my arm, into my hand and two fingers. Pain, limited movement.
64 2021-01-24 weakness bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time)... Read more
bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time) confusion; lightheadedness; headache/slight headache; This is a spontaneous report from a contactable nurse, reporting for herself. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EL1284), intramuscularly on the left arm on 05Jan2021 18:30 at a single dose for COVID-19 immunization. Medical history included received immunotherapy injections for environmental allergies from an unknown date and unknown if ongoing. Concomitant medication included diltiazem, spironolactone, trazodone, lorazepam, colecalciferol (VITAMIN D), zinc and fish oil. On 05Jan2021, the patient received Pfizer COVID-19 vaccine and experienced (time) confusion, and lightheadedness within one hour of receiving. Later that evening, the patient experienced headache. On 06Jan2021, the patient experienced injection site soreness x 2 days, continued with slight headache, lack of energy. On 08Jan2021, resolved injection site soreness of left arm, continue with slight headache. On 11Jan2021, The patient woke up with bloodshot left eye after having had headaches x 5 days which began the same evening of receiving the Pfizer COVID-19 vaccine. Blood pressure was 125/80. No headache or eye pain. BP was 128/89 on 10Jan2021, 11 PM. No headache. BP was 120/80 on 11Jan2021, 10 AM. The patient had never had a bloodshot eye before. The patient underwent lab tests and procedures which included Blood pressure:125/80 mmHg on an unspecified date, 128/89 mmHg on 10Jan2021 and 120/80 mmHg on 11Jan2021. The outcome of the event injection site soreness/injection site soreness of L arm was recovered on 08Jan2021 while the outcome of all other events was unknown.
64 2021-01-24 pain in extremity forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most... Read more
forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation. Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
64 2021-01-25 tingling, burning sensation c/o arm tingling after injection, 78-16-114/76 98% RA 1c/o R ear fullness, denies dizziness-A&Ox3, 7... Read more
c/o arm tingling after injection, 78-16-114/76 98% RA 1c/o R ear fullness, denies dizziness-A&Ox3, 77-18-120/7 ; full ROM noted-provided ginger ale 1016 78-18-112/61-97% RA R arm continues with "hot wire on 1/2 of Right forearm, continues feeling dizzy but not worse, using Zailo patch for pain control x 2 weeks; at 10:22, 74-18-110/59-98% A&Ox3, Right ear fullness/dizziness improving ; at 10:32 71-18-119/63-99% reports decreased ear fullness dizziness, more normal feeling on RFA, full ROM; @ 10:41, 71-18-102/56-98% denies dizziness or arm burning, ear fullness gone, no n/v
64 2021-01-26 unresponsive to stimuli Became unresponsive and was unarousable to sternal rub. A code blue was called and she woke up. Her... Read more
Became unresponsive and was unarousable to sternal rub. A code blue was called and she woke up. Her BP was elevated (176/120) and HR 45, o2 sat 100%, RR 16. About 15 minutes later, she had a repeat syncopal episode and was transferred to the emergency dept
64 2021-01-26 tingling Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and l... Read more
Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and left collarbone and neck; edema left arm pit and left collarbone and neck; tingling down the back of neck to shoulder blade for 1 week; All left side, pain at injection site with warm to touch for three days; All left side, pain at injection site with warm to touch for three days; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via intramuscular in left arm on 08Jan2021 13:15 at second single dose for covid-19 immunization. Medical history included diabetes type 2, allergies. Concomitant medication included metformin, simvastatin, semaglutide (RYBELSUS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose BNT162B2 (LOT# EL1685) on 20Dec2020 01:15 PM, via intramuscular in left arm for Covid-19 immunization. The patient experienced headache and body aches for 24 hours, edema under left arm pit and left collarbone and neck with tingling down the back of neck to shoulder blade for 1 week. All left side, pain at injection site with warm to touch for three days. Adverse event start date/time: 09Jan2021 06:00 AM. Events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was recovering.
64 2021-01-26 feeling cold Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving d... Read more
Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving dose, felt extreme coldness from shoulder to tips of fingers for about 30 mins and then resolved. Then afterwards, started to develop redness/itching/hives on back. Patient also felt very lightheaded and blood pressure taken and elevated at 188/84. (20-25 mins after injection). Injection site did swell and got red after. Also had mild HA after arriving home but didn't last long & nauseous feeling the whole day after getting vaccine. Patient did not take any medications and all symptoms resolved on own.
64 2021-01-27 pain in extremity Sore arm, Bloating, gas and diarrhea
64 2021-01-27 pain in extremity abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore;... Read more
abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore; nausea; GI problems; This is a spontaneous report from contactable consumer (patient). This 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0142), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included ongoing evolocumab (REPATHA, Expiration Date: 04Nov2021), ongoing amlodipine besilate (NORVASC, Strength: 10 mg) as high blood pressure medication, and ongoing amlodipine (Strength: 5 mg) as high blood pressure medication. The patient previously took first dose of BNT162B2 (Lot number: EJ1685) for COVID-19 immunisation. On 12Jan2021, patient got the second dose of the Pfizer COVID vaccine. She did fine all day, but then she started to feel a little nauseous off and on. Then at 4 o'clock before she left for work she developed muscle ache on 12Jan2021. It persisted to the point she could hardly walk this morning (13Jan2021). Patient has not had a fever. She hasn't really had a headache. It has just been muscle aches. Her arm was a little sore on 12Jan2021 but not bad. She has had muscle ache and GI problems with it. She had waves of nausea like she could throw up. She was hydrating really well. The nausea came and went. The muscle aches started at 3:30 to 4 with muscles aching. She got the vaccine to help prevent the spread of COVID and to protect herself as well. Patient experienced abdominal cramping and diarrhoea on 13Jan2021. Outcome of nausea and arm was a little sore was recovering, outcome of muscle ache, abdominal cramping and diarrhea was not recovered, outcome of other events was unknown.
64 2021-01-28 weakness Feeling weak; This is a spontaneous report from a contactable other healthcare professional (patient... Read more
Feeling weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 13Jan2021 (14:45) at single dose for Covid-19 immunization. The patient's medical history included anxiety and known allergy to Grapefruit. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced feeling weak on 16Jan2021 (23:00). There was no treatment received for the adverse event. The patient has been tested for COVID-19 post vaccination on 16Jan2021with Unknown result. The outcome of event was recovering.
64 2021-01-28 flushing, feeling hot Patient reports receiving Pfizer dose 2 at 0840 was self-observing for adverse reactions in waiting ... Read more
Patient reports receiving Pfizer dose 2 at 0840 was self-observing for adverse reactions in waiting area when at 0855 she developed a very hot feeling and became flushed. Patient notified vaccination staff. Patient denies any adverse reaction to Pfizer dose 1. 0855 BP 158/106, HR 109 SPO2 96%. Afebrile. Dr. evaluated Patient. 0909 Patient reporting flushed feeling, very hot and vision changes. Patient transferred to the Emergency Room for further evaluation. No medication administered.
64 2021-01-28 pain in extremity The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea. 48 hours l... Read more
The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea. 48 hours later your feeling much better. Took Tylenol and also Ibuprofen and stayed hydrated. Also had arm soreness, which she had with 1st vaccine as well.
64 2021-01-29 feeling hot COVID- 19 Vaccine. She was experiencing chest tightness, SOB, and dizziness. 50mg of Benadryl and 20... Read more
COVID- 19 Vaccine. She was experiencing chest tightness, SOB, and dizziness. 50mg of Benadryl and 20mg of famotidine was administered around 1410. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3mg of epinephrine was administered at 1420. EMS was called. Breathing improved. Pulse ox 100%, HR 68, BP 130/89. EMS arrived and assumed patient care. Pt seen in Emergency Room 1/16/2021 1513 CHIEF COMPLAINT: reaction to COVID vaccine HISTORY OF PRESENT ILLNESS: Patient is a 64y F with PMHx significant for Myopericarditis, Anxiety and HTN who presents to ER after developing tongue swelling, wheezing, tunneled vision and shortness of breath. Patient states that she was getting first shot of COVID19 Pfizer vaccine at 2:00 pm. After getting vaccine she waited 15 minutes like she was told and recalls room getting very hot at approximately 6 minutes after getting vaccine. She also states that her tongue felt swollen. She then noticed her vision started to turn dark and then she felt dizzy. She told pharmacist about symptoms and then she was given one pill of Benadryl. This did not help and actually made her symptoms worse. She recalls wheezing. She was given another pill of what she believes was Benadryl. She also recalls pharmacist measured her BP and her husband, who was present, reported that her blood pressure was in the 140s This did not improve so she was given 0.3mg IM epinephrine shot. This significantly improved her symptoms. However, she was sent to ER. She denies any hx of recent UTI or GI infection. She denies fevers, chills, nausea, diarrhea, chest pain, generalized itching, vomiting, abdominal pain, generalized swelling, headache or syncopal episode. She denies any past reactions to vaccines. She denies current SOB and feels like her symptoms resolved. Denies hx of COPD or asthma. Physical exam did not show any recurrent signs of wheezing or tongue edema. Her SaO2 was 100% on RA and BP was within baseline 140-160s. Given episode, we decided to obtain tryptase levels. We also observe patient to ensure she did not have any recurrence of symptoms. She remained hemodynamically stable and SaO2 remained in mid 90s to 100. She was given a rx for epinephrine pen should symptoms recur though this is highly unlikely as she remained stable throughout ER stay. She was also given instructions to pick up OTC Benadryl and Pepcid. She does have antihistamines listed as an allergy but patient states that she gets tachycardic upon taking tabs, so this could just be a side effect. We will follow up with tryptase levels but even if tryptase levels return as normal, it does not mean she did not have an anaphylactic reaction to vaccine. Her clinical picture puts this diagnosis high in the differential. Teaching and instructions were given to patient and her husband. She was advised to return to ER if symptoms recur. IMPRESSION: Anaphylaxis Anxiety attack
64 2021-01-29 numbness Pharmacy was called by outpatient provider, Dr regarding a reaction in a patient who received their ... Read more
Pharmacy was called by outpatient provider, Dr regarding a reaction in a patient who received their 2nd dose of the Pfizer Covid-19 vaccine (lot EL3247) on 1/21 at LMC. On 1/22, the patient reported with tachycardia, hypotension and arm numbness. Dr was concerned that the injection was given too high on the patient's arm and potentially into the shoulder joint. Patient was directed to the LMC ED for treatment. The patient was given fluids and was discharged home. The ED provider did not believe the vaccine was given into the joint.
64 2021-01-30 pain in extremity Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like... Read more
Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like blue blazes, itched intensely, and I had a fever of 102.4. To get my temperature down to 100 degrees I had to alternate Motrin and Advil. I continued to have a fever, headache, body aches, chills, and lethargy for the next 48 hours and stayed in bed because I felt so awful. Unable to do normal activities of daily living.
64 2021-01-31 pain in extremity Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am tha... Read more
Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am that morning. Intense fatigue and moderate headache. I had joint and body aches. I experienced lightheadedness when I got up when fever was 101.8 at 2:30 pm. I had to lay down again and apply a wet towel. Once I felt able to walk (about 10 minutes later) I ate a popsicle and then proceeded to take two 325 mg of Tylenol. Within 30 to 45 minutes fever subsided. I then ate soup, crackers and an orange and drank cranapple juice. I went back to bed and slept some more. I woke up at 5 pm and had a cup of soup, a quarter of an apple and gatorade. At 9 pm I took two more Tylenol to be safe and when to sleep. Sunday I was fine. My arm, never was swollen only a little sore.
64 2021-01-31 pain in extremity Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a sponta... Read more
Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a spontaneous report from a contactable consumer reporting for herself. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration, on 11Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient reported that she received her COVID Vaccine on Monday afternoon 11Jan2021. The patient experienced events doesn't feel good and her arm is sore on an unspecified date in Jan2021. On 11Jan2021, after she got the shot, an hour after she started getting nauseous. On Tuesday, 12Jan2021, she experienced headache that went away the next day. On 13Jan2021, her muscles started to ache. That lasted on Wednesday (13Jan2021), Thursday (14Jan2021). On Friday (15Jan2021) afternoon, when she got home from work, she started running a fever and at the time of report she was still running a fever. She stated, "as of right now starting yesterday afternoon, I've got my fever, I don't feel good, I ache, my arm is sore but that's okay. It started Monday afternoon after I got the shot, an hour after I started getting nauseous that was Monday afternoon. Tuesday, I got headache that went away on Wednesday. On Wednesday my muscles started to ache. And that was Wednesday, Thursday and Friday afternoon when I got home from work, I started running a fever and I am still running a fever." When confirmed if the consumer wanted to report the same or looking for some information, consumer stated, "I want to report this and I just want information, what do I do? I test twice a week, rapid test and saliva test for COVID. And I have tested negative for months. And I tested negative before I got the vaccination, I tested on Thursday (14Jan2021), I am still negative. That was the rapid test." The patient took ibuprofen as a corrective treatment for the reported adverse events. Outcome of the event headache was recovered on 13Jan2021, outcome of fever was not recovered, while outcome of the other events was unknown. Information on the lot/batch number has been requested.
64 2021-01-31 tremor, pain in extremity Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever ... Read more
Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever of 99, fatigue, pronounced pain in arm and shoulders
64 2021-01-31 pain in extremity Sore arm after the first dose of COVID Vaccine; This is a spontaneous report from a contactable othe... Read more
Sore arm after the first dose of COVID Vaccine; This is a spontaneous report from a contactable other health professional (Patient). A 64-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK57530), via an unspecified route of administration on 17Dec2020 09:10 at left arm, at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient experienced sore arm after the first dose of covid vaccine on 17Dec2020. She received the first dose on 17Dec2020 and tolerated pretty well. She only had a sore arm. It started the same day on 17Dec2020, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. the outcome of the event was recovered in Dec2020. Reporter considered the event Sore arm after the first dose of COVID Vaccine was not serious. Event did not result in Emergency Room/Physician Office. She also stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.
64 2021-01-31 tingling Within a half hour of receiving vaccine, I started feeling prickly from my torso down. When I got h... Read more
Within a half hour of receiving vaccine, I started feeling prickly from my torso down. When I got home I realized that I had felt this before and immediately removed my scrubs. I had raised red areas on my bilateral thighs and torso. I took Benadryl po.
64 2021-02-01 pain in extremity Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; N... Read more
Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; Nausea; She felt like she had a temperature and by the time it was checked her temperature was 101.9/febrile; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left upper arm on 07Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, not a Military Facility. The patient's medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient received the first dose of BNT162B2 (lot number: EK57530), via an unspecified route of administration at left Upper arm on 17Dec2020 9:10AM for covid-19 immunization. She only had a sore arm. It started the same day, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. She got the second dose on 07Jan2021. After the second dose, immediately, like within five minutes her arm became very sore, this event was assessed as non-serious by HCP. Also, that Thursday (07Jan2021) night after getting the second dose of the Vaccine around 9PM-10PM she started to get chills, myalgia, severe headache, and nausea. She also mentioned she was so sick during the night she was not able to get up and around. She felt like she had a temperature and by the time it was checked her temperature was 101.9. She was febrile all through 08Jan2021. She started to become afebrile 09Jan2021 with improvement and by 10Jan2021 all her symptoms had gone away and completely resolved. Seriousness Criteria: Stated she felt these are serious. She was unable to go to work on Friday. She could not return back to work until Monday. The HCP assessed all events were related to the vaccine. The outcome of the events was recovered on 10Jan2021. She stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.; Sender's Comments: Based on plausible temporal relationship, clinical course and known safety profile of the product, the reported events chills, myalgia, severe headache, nausea and fever were likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
64 2021-02-01 feeling hot broke out in hives on her face, arms, and chest; warm feeling; Itching; face was really swollen; fac... Read more
broke out in hives on her face, arms, and chest; warm feeling; Itching; face was really swollen; face was really swollen and red; skin was blotchy; This is a spontaneous report from a contactable consumer reported for herself. A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) at single dose via an unknown route at right arm on 16Jan2021 about 11:00 for vaccination against Covid. No additional vaccines administered on same date of the Pfizer Suspect. Medical history included anxiety, high blood pressure, and ongoing physical urticaria (with no investigation assessment) where if she gets warm her arms itch and she breaks out in a little bit of hives, but never to this extent. Concomitant drugs included lisinopril at 20mg, 1 tablet by mouth once daily for high blood pressure, and sertraline at 50mg, 1 tablet by mouth once daily for anxiety, both ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as "none". No other vaccines given the same day and none 4 weeks prior. No history of problems with vaccines in past. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine was "none". No events following prior vaccinations. Family medical history relevant to the event was reported as "none". Patient reported an adverse event/side effect to the Covid vaccine, and was not sure if she should go ahead with the second dose or not. Patient received the vaccine on 16Jan2021 (reported as Saturday as of 18Jan2021) about 11am and at 5pm she started getting a warm feeling and changed to cooler clothing. Patient started itching and then broke out in hives on her face, arms, and chest. Patient used a cool cloth to face to cool off and sat under the fan. Her daughter got her some diphenhydramine hydrochloride (BENADRYL) within that 15minutes and about 20-30 minutes of taking the diphenhydramine hydrochloride it was calming down. Patient only took 1 diphenhydramine hydrochloride to help and that took care of it. This was the only occurrence. Her face was really swollen and red, she looked like she was sun burnt, skin was blotchy, but she didn't have any trouble with breathing or heart palpitations. The event onset date was 16Jan2021. The events did not require a visit to Emergency Room/ Physician Office. No relevant tests performed. Outcome of the events was resolving.
64 2021-02-03 pain in extremity Patient's arm was sore and bruised; some of the fluid dripped down her arm/"all of the vaccine came ... Read more
Patient's arm was sore and bruised; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; it hit the bone/ it was given in bone; it hit the bone and after the nurse pulled back the needle, some of the fluid dripped down my arm; "it hit the bone"/When it was given it felt like cracking in her bone; patient's arm was sore and bruised; This is a spontaneous report from a contactable nurse. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EL3248), via an unspecified route of administration in the left arm, on 16Jan2021 08:15 at SINGLE DOSE for COVID-19 immunization. Patient had no relevant medical history. The patient's concomitant medications were not reported. The patient stated that during vaccination last Saturday(16Jan2021), "it hit the bone". The nurse pulled back the needle and after that some of the fluid dripped down her arm. Then it was further reported that it was given in bone and "all of the vaccine came out and dripped down to her wrist". Hence, they wanted to know if patient should get it re-administered or get another half dose. Patient's arm was sore and bruised, the first day was so sore but it was getting better. When it was given it felt like cracking in her bone and she thought the needle broke. After the nurse withdrew the needle, she was told it was not broken but said the needle must have gone to the bone. The outcome of event "patient's arm was sore and bruised" was recovering whereas the outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
64 2021-02-03 weakness, discomfort Shortly after the vaccination I developed a really bad headache for the first 2 days. Stopped for a... Read more
Shortly after the vaccination I developed a really bad headache for the first 2 days. Stopped for a day and returned for another day and went away on its own. I had inside body chills, felt weak and tired and had a little sinus pressure but no fever which lasted for about 2 or 3 days. I took aspirin to help with the discomfort and today I still have just a little nagging headache that comes and goes but all other symptoms has since subsided. The injection site swole and developed a knot which stayed about a week and is still a little red.
64 2021-02-03 feeling hot at 3:22, Pt waved down (EMT) on site. Clt sitting in vaccination observation area. C/o feeling hot,... Read more
at 3:22, Pt waved down (EMT) on site. Clt sitting in vaccination observation area. C/o feeling hot, dizzy, and lightheaded with vasovagal like symptoms. Pt moved to reclined position, and reported immediate relief. Vitals taken at 3:35: BP 132/90, 66 HR. Denies other s/s allergic reaction. Clt sat up 8 min later, states symptoms resolved. Clt completed Vaccine observation period, ambulated self to bathroom and left site at 3:46 pm.
64 2021-02-03 weakness more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; Th... Read more
more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine), intramuscularly on 15Jan2021 at single dose into the left arm for COVID-19 prophylaxis. Medical history included asthma; blood pressure abnormal (she takes blood pressure medication); palpitations at times; having mild chest discomfort, had experienced this before, that she was attributing to her wearing a mask, she wore 2-3 masks; stated that she had Covid once and she did not want it again. Concomitant medications included some blood pressure medication, and salbutamol (ALBUTEROL) inhaler periodically. Caller is a LPN nurse that was calling about the Covid-19 vaccine and reported that she received it Friday 15Jan2021 and just wanted to report some mild side effects. Caller clarified that she was more tired, had weakness, had diarrhea for 2 days, increased heart rate, and a runny nose, soreness at the injection site . She stated that she was not in a lot of distress. More tired started from 17Jan2021 and soreness at the injection site started from 16Jan2021. Weakness started from 17Jan2021: She stated that went home straight from work and went to the couch and slept about 6 hours. She had been up since 0300 and it was almost 1200 now. She stated that her energy level and weakness was pretty good right now. Diarrhea started from 16Jan2021: She said that she had the urgency to go and it was definitely soft and foul like when you had the flu. She stated that she has had it once since this morning. It was semisolid. Increased heart rate started from 17Jan2021: she felt palpitations at times. She said that she did not know if they were related, but stated that they were aggravating yesterday. She stated that she took blood pressure medication. She stated that she used a inhaler albuterol. She was using her inhaler periodically and said that it could be because of the albuterol inhaler. Runny nose started from 15Jan2021: Runny nose started about 8-10 hours after her injection. Stated that it was not bad, she would just have to blow her nose really good every so often. She said that she has not had to blow her nose today since she had been up. She said that the vaccine was sitting on the table and they just told her it was the Pfizer BioNTech vaccine. She did not have her vaccination card with her at the time of the call. The patient had recovered from weakness on 18Jan2021, recovered from increased heart rate and soreness at the injection site on 17Jan2021; she was recovering from more tired, runny nose, and she had not recovered from diarrhea. Reporter seriousness for increased heart rate, runny nose and soreness at the injection site was not serious. The reporter (nurse) considered the events more tired, weakness, diarrhea, runny nose and soreness at the injection site were related to bnt162b2, and relatedness of bnt162b2 to reaction increased heart rate was unknown. Information on the lot/ batch number has been requested.
64 2021-02-04 pain in extremity Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injecti... Read more
Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injection site red the size of a quarter, hot and sore to the touch and hard. Arm aches into shoulder.
64 2021-02-04 pain in extremity Significant joint pain - neck, arms, hands and legs
64 2021-02-04 weakness Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tirednes... Read more
Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tiredness & fatigue, foggy brained, extreme body aches and pain, unable to walk from weakness, nausea, excruciating headaches, irregualar heartbeat, nausea. Reddness and swelling in arm for over 1wk. Nausea about 10 days.
64 2021-02-05 facial pain Pain in L forehead and face, superficial. Started 2/2/2021, called MD 2/6/2021. MD diagnosed likely... Read more
Pain in L forehead and face, superficial. Started 2/2/2021, called MD 2/6/2021. MD diagnosed likely shingles reactivation (have had once before). Prescribed valcyclovir.
64 2021-02-09 numbness, pain in extremity The outside of my left started to tingle and went all the way down unto my hand and fingers, the out... Read more
The outside of my left started to tingle and went all the way down unto my hand and fingers, the outside of my palm from my little finger and up to about 2" above my wrist. After a couple of days only my hand felt and fingers were still numb. That lasted about a week and then the last week until the day that I got my 2nd injection (Feb. 5) only my little finger felt like that. I have that sensation in my hand again but it is very weak and it comes and goes. I have migraines and sometimes I have that feeling in my arm and hand.
64 2021-02-14 pain in extremity extreme swelling and severe pain in both wrists/ hands starting 2/7/21.seen in urgent care 2/8/21 an... Read more
extreme swelling and severe pain in both wrists/ hands starting 2/7/21.seen in urgent care 2/8/21 and admitted through ER on 2/10/21. Inpatient for 3 days. IV antibiotic DC'd when blood cultures negative. Ultrasound left arm negative for DVT. Seen by Infectious Disease and he felt it was due to covid vaccine reaction. Started on steroid
64 2021-02-21 tenderness Patient initially described superficial itiching of hands. Upon observation, was scratching all over... Read more
Patient initially described superficial itiching of hands. Upon observation, was scratching all over her torso and arms as well as neck. Benadryl 50 mg provided with improvement in superficial itching but endorsed internal abdominal itching and continues to touch her throat.
64 2021-02-21 difficulty speaking hoarse voise s/p 2nd vaccine 20 mins after vaccine
64 2021-02-22 hot flush C/o feeling hot flush heart rate 104. Denies no dizziness, nausea, chest pain, or SOB. EMS evaluate... Read more
C/o feeling hot flush heart rate 104. Denies no dizziness, nausea, chest pain, or SOB. EMS evaluated P 94 148/99. Ok to walk with husband as nd left for home w husband 12:26 pm.
64 2021-02-23 tingling Patient complains of tingling of the fingertips on her left hand. Denies weakness, numbness, dizzin... Read more
Patient complains of tingling of the fingertips on her left hand. Denies weakness, numbness, dizziness, headache, sob and chest pain. Denies lip/throat tingling/swelling.
64 2021-02-23 weakness Psoriasis came back all over my body. Psoriasis on hands for the first time! Extreme burning on sk... Read more
Psoriasis came back all over my body. Psoriasis on hands for the first time! Extreme burning on skin lesions. Headache, weak, overall feeling sick. I had Covid over thanksgiving 2020. I still had antibodies when I got my Covid vaccine.
64 2021-02-23 pain in extremity arm was very black and blue where the shot was administered and way around it/severe black and blue ... Read more
arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; yeast infection from it; incredible arm pain/arm was really hurting bad; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 12:00 at a single dose on the arm for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she was fine but on 23Jan2021 at 16:00, she experienced an incredible arm pain and fatigue. Her arm was really hurting bad. On 25Jan2021, the patient stated that her arm was very black and blue where the shot was administered and way around it. There was a severe black and blue mark and bump like a golf ball on the arm where she got vaccinated and had yeast infection from it. She never had this before since she never had a vaccine when she was a little kid. She wanted to know if they have heard about this before. She wanted to know if this was normal and if she needs go to the doctor. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient can't get appointment for second shot. The patient was not pregnant at the time of vaccination. The outcome of the events incredible arm pain and fatigue was recovering while the other events was not recovered.
64 2021-02-24 pain in extremity Radiating sharp pain that started in neck, then went to L of chest to L upper arm. Evaluated by EMS... Read more
Radiating sharp pain that started in neck, then went to L of chest to L upper arm. Evaluated by EMS, cleared.
64 2021-02-25 pain in extremity Normal arm soreness, very achy, tiredness
64 2021-02-25 difficulty speaking Patient started having tingling in her lips 5 days after the injection, then she began having a sore... Read more
Patient started having tingling in her lips 5 days after the injection, then she began having a sore throat, she started having a hoarse voice and she felt very tired. 911 was called. In route they were transporting patient she was hypertensive had normal heart rate they gave her Benadryl 50 mg orally and then epinephrine 0.3 mg IM which did not help patient at all.
64 2021-02-26 difficulty speaking, flushing Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to it... Read more
Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to itch a little. A little itching around eyes. About an hour after, felt tightness in my throat and neck, glands felt swollen. Became slightly hoarse, had to clear my throat often. Felt a little like asthma attack. Have had similar reaction when eating seafood
64 2021-02-27 pain in extremity Next day following vaccine - site injection pain (right arm). Arm pain has continued and progressed ... Read more
Next day following vaccine - site injection pain (right arm). Arm pain has continued and progressed limiting mobility. In the past 7 days patient has progressively declined in from independent to requiring assistance with walking. Pain and limited mobility in legs
64 2021-02-27 pain in extremity Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; ... Read more
Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; exhaustion 2/26 extreme fatigue; 2/27 extreme fatigue; nausea; diarrhea; headache
64 2021-02-27 numbness With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like e... Read more
With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like experience, muffled hearing, a foul taste in my mouth and altered state of eurphoria. Could not report symptoms but if had been asked directly could have. REalised half way driving home that I should not be driving. Eurphoria lasted for 24 hours. Was on phone constantly the next day for 7 hours straight without eating. Could not remember what some items were like a drone. Had to ask = that thing that flies with a camera. Short term memory loss that continues. Facial numbness began 48 hours after injection. Facial numbness continues changing in areas of right side of my face. Felt extremely vulnerable. Wore my same clothing for 4 days as I did not remember that I had clean clothing. Did not remember that I should notify medical personal until late 2/20.
64 2021-02-27 tingling tinkling in fingertips
64 2021-02-28 pain in extremity Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spo... Read more
Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at arm left on 09Feb2021 at 14:10 (at the age of 64 years) at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease, ongoing allergies, ongoing blood cholesterol abnormal. Concomitant medication included mesalamine (strength: 400 mg) oral at 400 mg twice daily for Crohn's disease, atorvastatin oral at 400 mg once a day for blood cholesterol abnormal, azathioprine oral at 50 mg twice daily for Crohn's disease, cetirizine oral at 10 mg for allergies, vitamin D at 1000 iU daily for supplementation, ketotifen fumarate (strength: 0.025 %) ophthalmic twice daily for allergies and ipratropium bromide (strength: 0.06%) nasal daily for allergies, all from an unknown date and ongoing. The patient experienced sore at the injection site on 09Feb2021, headache on the left side and her left arm was hurting from the shoulder down and she feels really tired and nauseous, all on 12Feb2021. The patient outcome of injection site pain was recovered on 09Feb2021; the outcome of the other events was not recovered. The information on the batch number has been requested.
64 2021-02-28 pain in extremity Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next ... Read more
Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next morning. No medication taken. Moderate headache lasting through next morning, general grumpiness for 2 days, brain fog beginning following morning - forgetfulness, depression. Still continued through today (Monday, March 1, 2021). Symptoms are not severe, but are acute enough that they are impacting quality of life.
64 2021-02-28 burning sensation, numbness Post vaccination return of CRPS/RSD related numbness and burning in each site where history of CRPS.... Read more
Post vaccination return of CRPS/RSD related numbness and burning in each site where history of CRPS. Have not been on any medications for the CRPS for over 2 years with minimal to no exacerbation of CRPS events. I have a long history of flair ups with insults to my body (e.g. post accident, post surgery, extensive dental work). The numbness and burning started to return within 2 hours of injection to the right side of my face and my right hand. Then these symptoms started to return to other locations on my body throughout the week (lower back, left knee and right ankle). The only site that has subsided 1 week post injection is my right hand though all symptoms have not resolved there either. The burning in my lower back got so bad on Thursday that I had issues sitting and scheduled an appointment with Dr. for Monday 3/1/21. Telehealth visit with Dr. this AM and returning to medication to treat CRPS/RSD till episode resolved.
64 2021-02-28 weakness Within 30-45 minutes after injection, I started to feel a tingling around my jaw area. Then 3 days ... Read more
Within 30-45 minutes after injection, I started to feel a tingling around my jaw area. Then 3 days later I have had several episodes of dizziness, weakness and nausea. This has continued until today (4 days) along with aching across sholders and behind eyes.
64 2021-03-01 pain in extremity upon receiving the vaccination I had a stinging pain and I bleed down my arm. The administer wiped i... Read more
upon receiving the vaccination I had a stinging pain and I bleed down my arm. The administer wiped it with a cotton ball. The person who administered the vaccine did not pull out or start over again. I believe she hit a vein. Now i have a scar on my arm. it is still painful and since it may not have been on a muscle I am not even sure I am vaccinated.
64 2021-03-02 pain in extremity sore arm; mild headache; slight fever; swollen painful axillary lymph nodes; swollen painful axillar... Read more
sore arm; mild headache; slight fever; swollen painful axillary lymph nodes; swollen painful axillary lymph nodes; This is a spontaneous report from a contactable healthcare professional. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at the age of 64 years, via an unspecified route of administration on the left arm on 28Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included allergies, MVP (Mitral valve prolapse), HBP (High blood pressure) and thalassemia. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously received the first dose of BNT162B2 on 07Jan2021 (age at vaccination: 64 years), lot number: Ek9231 and experienced mild headache tiredness bruised arm not at injection site. On 29Jan2021, the patient experienced mild headache, slight fever and swollen painful axillary lymph nodes. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, COVID test: negative on 15May2020 and nasal swab: negative on 01Oct2020. The outcome of the events was not recovered.
64 2021-03-03 pain in extremity, tingling Tightness in left bicep (front—not where shot administered) and forearm and tingling in hand (left ... Read more
Tightness in left bicep (front—not where shot administered) and forearm and tingling in hand (left side where shot administered. Tightness has dissipated somewhat, but tingling in hand continues to be present Sore throat right after administration Extremely sore arm for 2 days after administration
64 2021-03-07 pain in extremity, weakness My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling u... Read more
My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling unwell difficulty breathing a fast heartbeat weakness
64 2021-03-11 seizure Seizure like activity within minutes after vaccine; pt does have history of seizure disorder as well... Read more
Seizure like activity within minutes after vaccine; pt does have history of seizure disorder as well as some non-epileptic spells
64 2021-03-14 tingling angioedema; Face & tongue tingling; Face & tongue tingling; Itching all over; rash on limbs & chest;... Read more
angioedema; Face & tongue tingling; Face & tongue tingling; Itching all over; rash on limbs & chest; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration on 11Feb2021 11:15 (at the age of 64-year-old) at single dose in right arm for covid-19 immunisation. The patient other medical history included seizure disorder, hypertension, obesity, IBS (Irritable bowel syndrome), chronic rhinitis, atrial fibrillation. The patient had known allergies. No other vaccine in four weeks. The patient had received other medications in two weeks. The patient experienced face & tongue tingling. Itching all over, angioedema, rash on limbs & chest, swollen lymph nodes on 11Feb2021 12:00 PM. The patient received the treatment of events included diphenhydramine (BENADRYL). The outcome of the events was recovering.; Sender's Comments: The causal association between the reported event angioedema and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
64 2021-03-14 pain in extremity dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhe... Read more
dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhea; Super tired and went to bed by 8pm after COVID-19 vaccine; Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not receive any other vaccine the same day and in four weeks. Patient did not have COVID-19 prior to vaccination. The patient experienced passed out in floor (medically significant) on 24Feb2021 at 10:30 PM, diarrhea (disability) on 24Feb2021, broke a tooth (medically significant) on 24Feb2021 at 10:30 PM, dehydration (disability) on 25Feb2021 12:00 AM, slight fever (99) (disability) on 25Feb2021 at 12:00 AM, chills (disability) on 24Feb2021 at 10:30 PM, super tired and went to bed by 08:00 PM after COVID-19 vaccine (non-serious) on 24Feb2021, arm was sore (non-serious) on 24Feb2021, sweating (non-serious) on 24Feb2021 at 10:30 PM, dizzy (non-serious) on 24Feb2021. No therapeutic measures were taken as a result of the events. Patient stated that all side effects resolved completely by 25Feb2021 evening, except for broke a tooth. Patient did not tested positive for COVID-19 post vaccination. The information on the Lot/Batch number has been requested.
64 2021-03-14 flushing had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned brig... Read more
had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned bright red Subsided within hour.; Ate supper, Went to bed, upon waking in nite experienced imbalance; vertigo; Neck pain; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264, Solution for injection), via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 vaccination. Medical history included CAD (coronary artery disease), Irregular heart rhythm, BPPV, degenerative disc disease, anxiety, ptsd (post-traumatic stress disorder), pre diabetic, Allergies to food, chemical and sensitivities and med and sensitivites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. Upon receiving injection, on 30Jan2021, patient had flush feeling (much like injection during CT scan). Within hour her ears felt hot and turned bright red Subsided within hour. After supper, went to bed, upon waking in night experienced imbalance. Laying back down experieced vertigo (what she thought was a BPPV episode, a prior cond) but she couldnt figure out which side to treat, she performed maneuver. But did not resolve. She was remaining off balance and spinny even being upright with movement of head or eyes. Neck pain and headache residual nausea. About 12 hours after injection. Upside, her arm doesnt hurt. The patient did not receive any treatment for the events. No seriousness criteria was reported. The patient underwent lab tests and procedures which included computerised tomogram and results are unknown. The outcome of events was unknown.
64 2021-03-15 weakness, seizure Beginning February 28, 2021 stroke, seizure, fever, headache and weakness.
64 2021-03-18 weakness, flushing, pain in extremity Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little... Read more
Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little fatigue; Severe arm/injection site pain; Severe arm/injection site pain/very sore arm; Chills; Low grade fever; Headache; Lightheaded; Weakness/really weak; Itchy rash on chest/has a rash on her chest/little rash on my back; Nausea; Loss of appetite; She is flushed; tested positive for Covid and 6 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: EL9265) in right arm via an unspecified route of administration on 08Feb2021 07:45 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included osteoporosis, Inappropriate sinus tachycardia, known allergies. Concomitant medication included estradiol benzoate (ESTRADIOL [ESTRADIOL BENZOATE]), calcium (CALCIUM), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), naproxen (NAPROXEN), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all at once a day. The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient had the first vaccine on 08Feb (complete date not clarified), two days after that it had most of the side effects, with the one very sore arm, headache, fever chills, nausea, feeling very tired, about 6 days after that she tested positive for Covid and 6 days after the first vaccine. She tested positive for Covid so for the last couple of weeks. She had Covid, the fever broke about 5 to 6 days ago, she had a low grade fever after that, also the symptoms were gone now, there was little fatigue and little rash on back. She was scheduled to take second shot now and was trying to find in research about taking the second shot inspite of having covid. She cant find anything, most of the people never heard this and primary care physician said to go ahead and take the shot, but some people and some researchers said you should not, because she might have symptoms later and she should wait. The treatment was not received for the adverse events. Outcome of tested positive for Covid and 6 days was unknown and for other events it was recovering.
64 2021-03-20 feeling hot, tremor allergic to something in the vaccine; Myoclonic jerking; I felt very hot; I started shaking uncontro... Read more
allergic to something in the vaccine; Myoclonic jerking; I felt very hot; I started shaking uncontrollably.; Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at 16:00 (at the age of 64)(Batch/Lot Number: EN6205) as a single dose for covid-19 immunisation . The vaccination was given at a hospital. There were no other vaccinations given within 4 weeks. The patient was not diagnosed with COVID prior to vaccination. Medical history included breast cancer and an allergy to sulfa drugs. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); levothyroxine, liothyronine (NP THYROID). On 25Feb2021, about 2 hours after the vaccination (18:30) I felt very hot. I was not running a fever. I started shaking uncontrollably. The shaking was not chills. My husband took me to the emergency room. This was their summary. Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar level; Myoclonic jerking; Vaccine reaction I saw my general practitioner the following day and everything was back to normal. I am allergic to something in the vaccine and I am afraid to get the 2nd dose. No treatment was given for the events.The outcome of the events was recovered. The patient was not tested for COVID post vaccination.
64 2021-03-22 pain in extremity dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well o... Read more
dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well over 12 hours; stomach pain; big bump on my head where I hit the tile floor; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 05Mar2021, 16:30 as a single dose for covid-19 immunisation. The patient's medical history included allergies to Sulfa based meds from an unknown date and unknown if ongoing. The patient had Covid prior to vaccination. Concomitant medications included cranberry; colecalciferol (D3), fish oil, and multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 05Mar2021 at 18:30, the patient experienced headache, nausea, arm soreness 2 hours after injection. Chills for well over 12 hours. Most concerning, patient got up in the middle of the night. Used facilities. Washed hands, and was having stomach pain. Then she passed out. she came to, and have a big bump on her head where she hit the tile floor. Sunday Morning (07Mar2021) she was dizzy. Maybe from the bump on her head. The patient did not received treatment for the events. The outcome of the events was recovering at the time of the report. The has not tested positive for Covid-19 post vaccination.
64 2021-03-24 bell's palsy Bell's palsy; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old Female... Read more
Bell's palsy; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Feb2021 at single dose in left deltoid for COVID-19 immunisation at the age of 64-year-old. Lot number was EN6200. Relevant medical history and concurrent conditions included Herpes zoster/ shingles, Bells palsy, overweight. Concomitant medications included ergocalciferol (Vitamin D) for her bones and that kind of stuff. First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was received on 21Jan2021 for COVID-19 immunisation at the age of 64-year-old. Historical vaccine included typhoid, malaria and yellow jacket. Patient initially confirmed she has had no reactions after prior vaccinations. On 06Mar2021 at 02:30, the patient experienced Bells palsy; the event was considered Medically significant; the patient visited emergency room; the patient was given Zanamivir, antiviral in the Emergency Room. The patient had been told by other people that she should get started on a steroid, so she started prednisone, prescribed by the NP at her primary care. Patient had right facial paralysis right at the time of report, it was slightly worse than when she first noticed it. The patient did not think she has reached the maximum of the Bells Palsy and she had to drink coffee out to of a straw and issues with her words. The patient did not recover from the event. The reporter mentioned that she has had several family members who have had Bells Palsy. The odds that she received something that could trigger some kind of immune response, the time frame, the fact she got the vaccine, also fact she has a history of shingles she would have to associate with the vaccination. The reporter had done mission work and has never had a reaction to any of the vaccines that she received for that.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
64 2021-03-30 tremor Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a s... Read more
Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a spontaneous report from a contactable retired nurse. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), at vaccination age 64-year-old via an unspecified route of administration in the right arm on 13Mar2021 09:30 as a single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient reported that she had side effects after getting her first dose of the Pfizer COVID-19 vaccine Saturday morning (13Mar2021) at 09:30am. She mentioned that she developed side effects Monday (15Mar2021) night that she also had all day Tuesday (16Mar2021), it was pretty significant. She mentioned that she is concerned about getting the second dose, and she is thinking that she is not going to get that after having her first dose. She stated that her side effects lasted all night Monday night, she had shortness of breath and coughing. She added that on Tuesday morning she started having chills, shakes, throwing up or vomiting, and having massive diarrhea all day long. She also mentioned that she thought it was serious, and she was going to have to go to the hospital soon. She wasn't going to have a choice if it hadn't gotten better. She reported that all her side effects are better, and that for treatment, she took some Delsym cough medicine and diarrhea medicine, Imodium, she thinks it was called. She says she took one dose of the cough medicine yesterday morning, and she has taken 3 doses of Imodium today. She wondered if she should take the second shot or if she would get the same symptoms again. She says she is hesitant to take second one because she doesn't want respiratory distress again (Mar2021), it was horrible, and she has never had massive diarrhea before to where she couldn't get to the bathroom, it was the worst thing she has went through. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect productbnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), to reported events is possible.
64 2021-03-31 inability to speak At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt a... Read more
At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt as if my heart was vibrating. I am sure later I had a TIA. Was unable to communicate. I knew what I wanted to say but I could not get the words out. March 1/2021 I went on FLMA. It never dawned on me the vaccine could have affected my already stressed heart. I am still experiencing these symptoms. I just thought of this this week. I still have extreme fatigue, increased palpitations, and increased SOB. I do not feel able to work right now.
64 2021-03-31 feeling hot Passed out at the casino and transported to Hospital b y Ambulance. I Was kept overnight. Feeling ... Read more
Passed out at the casino and transported to Hospital b y Ambulance. I Was kept overnight. Feeling light headed , dizzy and hot. . 1 day after the second doze of the pfizer shot. Passed out approximately 15 minutes after filling the symptoms.
64 2021-03-31 pain in extremity acute left leg pain and swelling 15 hour after vaccination with subsequent same day ER visit and ult... Read more
acute left leg pain and swelling 15 hour after vaccination with subsequent same day ER visit and ultrasound diagnosis of acute left leg DVT (blood clot) diagnosed.
64 2021-04-02 pain in extremity headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad press... Read more
headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad pressure in the back of her head; felt like her heart was skipping beats; heart rate and blood pressure seem to be very erratic; erratic heartrate; arm swelled up and was sore; arm swelled up and was sore; lump in throat; unwell feeling all over like she was going to pass out.; unwell feeling all over like she was going to pass out.; She kept getting an icky feeling; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [26Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot Number: EN6204), intramuscular, administered in right arm on 08Mar2021 14:10 (at the age of 64-year-old) at single dose for Covid-19 immunization. Medical history included high cholesterol, osteoporosis, high blood pressure, arthritis, stenosis of neck and spine, allergies to dust and cleaners (when she cleans, the bottom of her neck swells up huge); all were ongoing. She has very high cholesterol, she believes it was close to 400 the last time it was checked and that's why she was given Repatha which brought it way down, but she doesn't know if she can take the Repatha again. She also has quite a few allergies - allergic to cats, sulfa, grass and Pre-diabetes. She has a fair amount of allergies. Her doctor thinks she has some asthma because she has had a little trouble breathing at different times, but she doesn't have an inhaler or anything. She mentions asthma and allergies run in her family. The patient also stated that a majority of her life, has had low blood pressure until about 9 years ago when her father passed. States that her blood pressure had been out of control for 6 months and was then put on a low dose of Carvedilol, and eventually evened out. Concomitant medications included ongoing carvedilol taken for blood pressure; ongoing loratadine (CLARITIN) taken for allergies from 1996 (has been taking for 25 years); ongoing lansoprazole taken for acid reflux; ongoing rosuvastatin calcium taken for cholesterol since Sep2020; ongoing calcium; carvedilol (COREG) taken for blood pressure. The patient had a previous reaction to a cholesterol medication evolocumab (REPATHA) from 23Oct2020 to 23Oct2020 - her neck swelled up pretty big and she had hives on her chest, which ended up going away. Therefore, she doesn't know if she can take that again or not. The patient also previously took rosuvastatin calcium (CRESTOR) 5-6 months ago and it made her legs ache really bad; esomeprazole sodium (NEXIUM) and had the problem; lansoprazole (PREVACID) for acid reflux. She took Nexium which was a different product with different ingredients and her blood pressure was still high the whole day. States that her doctor had prescribed another brand, which had the same main ingredient as the Nexium, and told her to double up on it one night, so she did that and about an hour later she just about hit the floor because her blood pressure shot up to about 200 over 100 and something, so she talked to the pharmacist who said that this was not a normal reaction to the ingredients in Nexium, but it happened to her every time she took it. She had been taking Prevacid for a long time but then started to get an allergic reaction. Clarified that feeling like she was having an allergic reaction after taking the Prevacid at night, was something that she has just started noticing within the last month. Wondering if the 2nd dose of the Prevacid is too much. States that she still takes this in the morning but not in the evening. States that she has started taking 15mg at night from an over the counter version of the same medicine (Lansoprazole). She explained that she hasn't had any vaccines as an adult, she never has had a flu shot. About 5 years ago, she had a bat in the house for 3 days and the bat ended up hitting her in the head and forehead as they were trying to get the bat out of the house, so she ended up getting a rabies vaccine. She was wondering and hoping there were no interactions with that. With the rabies vaccine, she did have a headache. She had to get 4 or 5 shots and she did not feel well most of the time. It took a long time to pass for her to feel normal again. The caller received the first dose of the vaccine last Monday on 08Mar2021, after the shot and while waiting those 30 minutes, she felt a lump in her throat which lasted all day and the next day, but it went away. She confirms by 10Mar2021, she recovered completely. Her arm swelled up and was sore for a day and half on 08Mar2021, but that went away. She isn't worried about that. She also has a really bad headache and was very dizzy on unspecified dates. She is concerned about the dizziness. She has been driving, but about the second day after getting the vaccine, she was leaning over talking to her mom and she felt like she going to pass out. She didn't, but she felt like she was. She has been using hot packs. It's like she has a headache around her temples and the back of her head seems to be hurting. In fact, she put a hot pack there while waiting to speak to this call handler. She doesn't know if its tension or what. She didn't have hives or none of that from COVID vaccine which she was excited about, but she is so dizzy she can hardly stand. She can't get rid of the headache and dizziness. She wants to know whether or not to go ahead with the next vaccination. This is the 5th day of having this dizziness. She was thinking the dizziness was going to last for a couple of days, but its going on 5 days. Even just sitting, She states it's kind of scaring her. She was thinking it would just go away, but it isn't. Her heart rate and blood pressure seemed to be very erratic on 12Mar2021. She woke up this morning (12Mar2021) and her blood pressure was very high, but she checked it within a few minutes and was dropping low. Her heart goes fast and then slows down, but she has had problems with this in the past. The dizziness has been bothering her a lot, she has been afraid to drive. The patient had a blood pressure of 150/102 on unspecified date. On 17Mar2021, She mentioned she will see her HCP at 2:00 PM. She has already filed a report regarding the side effects she had. She filed a report and asked if she should get the second dose shot. However, she was informed if her HCP called, they may be able to provide her with more information. She was informed her HCP could call the medical line. On 26Mar2021, she stated that the first report was filed the first week and that during the second week, more not good things have been happening. She wrote down the report number from the first report but does not have it now. Since the vaccine, she has been having different symptoms; she is not sure if it is related to the vaccine but wanted to report it. She was a little concerned because she has allergies, stating she had just tried an injectable cholesterol drug and she did break out hives and her neck had swelled. States that she has not had any vaccines as an adult, so she was a little bit cautious anyway. She clarified that she did not have hives and did not have any breathing problems when she left. Stated that later that evening and the next day had a really bad headache and bad pressure in the back of her head, which she knew was typical. States that 3 or four times she felt a rush over her body and felt like she was going to pass out. That night and the next day (unspecified date), she was having breathing problems (was not breathing very well for 3- 4 days) and her chest was tight and she was starting to wheeze, and continued for about 3 or 4 days. She kept getting an icky feeling Monday and Friday when she got up and had unwell feeling all over like she was going to pass out on unspecified date in Mar2021. States she had real bad pressure in her head and high blood pressure and felt like her heart was skipping beats on unspecified date. States her blood pressure was around 152/100 on 09Mar2021. One-day blood pressure was real low, 88 over something but that kind of went away. States all that information was already reported. The next week, she thought she was feeling better and that Monday and Tuesday felt back to normal. Stated that on Thursday night (Mar2021), she was just sitting and around 8 o'clock her blood pressure spiked within a few minutes to around 184/105 and she wasn't doing anything; she couldn't get it to go down. States that she went to the ER to check everything out last Thursday. Every night since then, somewhere around 8 o'clock, her blood pressure spikes really high. Stated she then called her doctor. Stated she was on a really low dose of blood pressure medication, stating that she had occasional problems with her blood pressure in the past but it never went that high. Her blood pressure was usually in the 140's or 150's over 90 something. States that now it is much higher and happening every night. Caller stated that Wednesday night (24Mar2021) her blood pressure started to spike every 5 to 6 hours, stating it first started at 830 at night and again at 230 in the morning. She has been feeling unwell since that shot. Her doctor thinks it may be causing inflammation. States that they doubled her medication last night and her blood pressure is still going up and up, but usually goes down after a couple of hours. It is totally uncontrolled and her doctors are trying to figure it out. States that meds have been added, including Xanax and will be going to see a heart doctor. States that this has all been since the vaccine. Caller would like to know if people are reporting these symptoms. States that it is pretty terrible, and that she feels normal and then it rushes over her. States that it is exhausting and that she almost went to the ER last night. States that she does not want to go back if she does not have to. When she filed the first report she did not have issues with blood pressure yet. Again, she had the vaccine on Monday 08Mar2021 and that the next Thursday she felt like her heart rate was really high. During that first week, she felt out of rhythm, like missing beats. Her blood pressure dropped low the first week and that just one time was around 152/100 but it didn't sustain. It then dropped pretty low one day. The next Thursday, it was uncontrollable. It was around 180 over 104 or 105 and that it kept going up, but then back down to 160/90 something. Took Xanax and went to bed, when she woke up this morning it was low, but went right back up within 5 minutes. In the first couple of days, they increased her blood pressure medicine and it seemed to be bringing her blood pressure down and she was able to go to bed. The caller stated that Monday, it will be three weeks. States that a day and a half after the vaccine, her arm was not hurting but was still puffy, but not bad. States that when she runs her hands over it, it is still sore to the touch and a little swollen but nothing extreme. She was concerned that her blood pressure keeps going up and then down. States that the blood pressure started spiking on the 18Mar2021, in the evening very quickly and was very high. Stated that this was happening every night since then until the 24th, when it started spiking every 5-6 hours; and her blood pressure medicine wasn't controlling it like it was earlier in the week, even though the dose was doubled. For one day it worked good and brought it down low but then, it wasn't controlling it anymore. She stated no relevant tests, related to this event but states that in her last 2 labs her cholesterol was high. States that it was over 300 and her bad cholesterol double or more triple. States this has been going on for many years. States that she changed her calcium to calcium with vitamin D and her vitamin has come back up. When she was in the ER they did a Metabolic panel and everything looked okay. The adverse events require and emergency room visit. The patient recovered from the event lump in throat on 10Mar2021; the events arm swelled up and was sore recovered in Mar2021; the events erratic heart rate, chest was tight, was not breathing very well for 3- 4 days, wheezing resolved on unspecified date. The outcome of dizziness, blood pressure seem to be very erratic was not recovered and the outcome of the remaining events was unknown.
64 2021-04-06 pain in extremity, tingling Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling... Read more
Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling in Lt, eye then swelling in Lt. eye lids, lt. cheek, lt. corner mouth which progressed. This was witnessed by the team giving vaccine and later on by EMT on the scene. Post feeling dizzy along with swelling the EMT person had me leave my car & placed me on litter in ambulance waiting in parking lot. Within 5 -6 mins. of the shot, I then felt severe HA, and swelling in my throat. EMT immediately started IV - gave IV Benadryl, then gave 1 shot of Epinephrine. Called EMT which took me via ambulance to hospital. There EM MD assess then gave me Solumedrol IV push & admitted me to ED OBS formally. Felt better but then few hours later all symptoms returned along with severe pain in hand with red palms & cyanotic finger tips. ED MD treated me again with higher dose of Benadryl & add Prilosec for potentiation of Benadryl and observed me. Felt better after several more hours. Was discharged on 50 mg Prednisone X 5 days & prescription for Epinephrine pen. Followed up w/PCP couple days later.
64 2021-04-07 tremor Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; mal... Read more
Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; malaise; severe Tremor; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 at 15:15 on the left arm as single dose for COVID-19 immunization. Medical history included bipolar disorder type 2, known allergies to sulfa. Concomitant medications included taking unspecified other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies. The patient did not have covid prior vaccination and there was unknown if the patient had covid tested post vaccination. On 13Mar2021 at 12:00 PM, the patient experienced severe nausea, fatigue, muscle and body aches, headache, low grade fever, malaise 3 days after vaccine since then patient had developed a severe tremor; that all events resulted in disability or permanent damage. Patient received a positive result from a serum antibody test for covid 19 on 29Mar2021 (reported as two days ago, as of 31Mar2021). Patient cancelled her second vaccination appointment. Lab data included serum antibody test was positive on 29Mar2021. There was no treatment received for the adverse events. The outcome of events was not recovered. Information about Batch/Lot number has been requested.
64 2021-04-07 cold sweat pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and ... Read more
pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering. Additional information has been requested.
64 2021-04-09 weakness, pain in extremity feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain... Read more
feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved. She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered. Information on the lot/batch number has been requested.
64 2021-04-09 difficulty speaking horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; horrible hives... Read more
horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; she was a little bit red; blood pressure lowered a little bit; This is a spontaneous report from a Pfizer sponsored Program . A contactable Physician reported for herself that. A 65-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 14Feb2021 15:00 (Batch/Lot Number: FL9267) as SINGLE DOSE for covid-19 immunisation (Age at vaccination was 64 years). Medical history included immunocompromised and she is a very allergic person and can treat allergies. Concomitant medications were not reported. On an unspecified date patient experienced horrible hives and hoarseness and itching, she was a little bit red and blood pressure lowered a little bit. It was reported that after the 1st dose of the Pfizer COVID Vaccine, it seems like she was a little bit red and she did not pay much attention to it then at night on the 2nd day and that night became horrible hives and hoarseness and itching; caller states these symptoms are not ongoing and lasted about 4-5 days; states the 2nd day the hives started at night about 24 hours over. Caller states then the symptoms disappeared and she used an antihistamine Benadryl and every time she takes it is 50mg and she then used Zyrtec 10mg and only used the Zyrtec twice and had terrible side effects from the Zyrtec and did not like it and prefers the Benadryl; no further details provided by the caller. Caller states because she was an allergic subject, she always has Benadryl at home. the first night after she had the Pfizer Covid vaccine, she had her epipen with her but was following her blood pressure and pulse and the blood pressure lowered a little bit but not terribly and the pulse was the maximum of 99 so she decided not to go to the emergency room and she stayed home and did not do the epipen; states she decided to stay home and monitor herself but she was ready to go to the emergency room if needed and by 9:00pm she seemed fine and only her blood pressure had slowed a little bit and her pulse at one time went to 99 and she did not do the epipen; despite further attempts at clarification, the information is captured as stated by the caller. Caller states the 2nd dose (lot number EN6204) was administered on 13Mar2021 around 12:00pm. The patient underwent lab tests and procedures which included blood pressure measurement: lowered a little bit, heart rate: maximum of 99 on, sars-cov-2 antibody test: negative on 29Mar2021. Reporter seriousness for antibody test that was done came back negative was Medically significant. Outcome of the events was recovered on unspecified date.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-04-11 discomfort c/o numbness in the lips and heavy tongue
64 2021-04-17 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on 06Apr2021 13:00 at single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 06APR2021 at around 1PM. She woke up in the middle of night (she usually does so). When she woke up this morning and had a cup of tea, noticed that she was "somewhat sensitive to caffeine" which is unusual because she liked drinking coffee. On 07APR2021, her heart rate (HR) is 96 beats per minute (BPM), which is high because her usual HR is 60 BPM. Her oxygen levels are normal (98%). She asked about this possible side effect to the vaccine, aside from her sore arm. She asked if she could take Ibuprofen. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021389552 Same reporter/drug/AE, different patient
64 2021-04-17 burning sensation, numbness possible pinched nerve; TIA; heart rate is low anyways from the medications but it dropped to 35 whe... Read more
possible pinched nerve; TIA; heart rate is low anyways from the medications but it dropped to 35 when she was in the hospital/heart rate dropped; her right arm, the right side of her face, and her right knee were numb/ she has numbness in her right finger and right thumb; face feels like its burning; her vision was kind of blurry; sensational loss in her right hand; caller's sclera looked like her eye was bleeding and her pupil started turning a different color.; caller's sclera looked like her eye was bleeding and her pupil started turning a different color.; eye was super red; rupture of a blood vessel in her eye; blood clot in eye; This is a spontaneous report from a contactable nurse (reported for herself). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER2613, expiry date not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 at a single dose for covid-19 immunisation. Medical history included ongoing hypertension from 1900 wherein blood pressure was high prior to her atrial fibrillation medications; A fib (atrial fibrillation) from 2016 and ongoing; and ongoing heartrate low. As a child the caller had the vaccine in the sugar cube (unspecified) and her mouth was swelling from it; and stated that patient's sister was hospitalized after receiving the same vaccine. Family medical history included mom has hypertension. Concomitant medications included apixaban (ELIQUIS) taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 5 mg twice a day; sotalol taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 80 mg, twice a day; and diltiazem taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 180 mg, once a day. The patient was a healthcare worker and she has had friends who have died from covid. The patient had no previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations (within 4 weeks). The patient stated she had the first dose of the vaccine and had a TIA (Apr2021) and rupture of a blood vessel in her eye 20Mar2021. The TIA was on Monday (Apr2021) and she was supposed to have her second dose tomorrow (09Apr2021). She stated she may get it but she is not taking it tomorrow because she is still having residual symptoms. She asked what the length of time she can wait to get it before she has to restart. Patient reported that after she got her first vaccine she had a ruptured blood vessel in her eye the next day (20Mar2021). She put warm and cool compresses on her eye then the ruptured blood vessel subsided. The ruptured blood vessel came back again a few days later and this time it was the entire sclera. She developed blood clots in her eye and the doctor said it probably wasn't from the vaccine (Mar2021). She was supposed to get her second dose of the vaccine tomorrow 09Apr2021 but she was going to hold off for now. She then had a TIA (Mar2021) and became hospitalized because of it from 06Apr2021 to 07Apr2021. The patient has ongoing atrial fibrillation but has been taking her medication religiously. She believed that the TIA was from the vaccine as there was no explanation as to why it happened. Her heart rate was low anyways from the medications (dates unspecified) but it dropped to 35 when she was in the hospital (Apr2021). The patient's primary care provide was not the attending in the hospital when the caller was hospitalized. Furthermore, it was reported that on 21Mar2021, patient's eye was super red but only on one side of her left eye. On Tuesday, 22Mar2021, caller went to see her primary care provider and they told the patient to put a warm compress and no eye drops in her eye, that helped. Then that Friday, 25Mar2021, the patient's sclera looked like her eye was bleeding and her pupil started turning a different color. Then last Monday (Apr2021), the patient woke up and her right arm, the right side of her face, and her right knee were numb she got up and went to see if she had a facial droop and did not. The patient thought it was from her sleeping wrong, but these symptoms did not go away. The patient went to the Emergency Room where they did a CT of her head and neck, with and without contrast which was negative. The patient was admitted on 06Apr2021 to the observation unit where they did an MRI and ECHO, which were both negative and she was diagnosed with a TIA and possible pinched nerve (Apr2021). The patient denied any heavy lifting prior to this event other than normal day to day things. The patient was discharged on Wednesday 07Apr2021. The patient's face felt like its burning, she has numbness in her right finger and right thumb. Physical therapy and occupational therapy said the patient should be okay but to be careful with things that were hot because she was at risk of burning herself. The second time the patient's eye became red, her vision was kind of blurry (Apr2021) and she didn't know if the blood was in her pupil. The only deficit that the patient has now is sensational loss in her right hand (Apr2021) and that should improve per the occupational therapist at the hospital. The caller was supposed to get the second dose of the vaccine on 09Apr2021 but she doesn't want to take it while she is having these symptoms. Results of tests and procedures for investigation of the patient included: head ct with and without contrast: negative on 06Apr2021; MRI brain: negative on 06Apr2021; Echocardiogram: negative on 07Apr2021; speech evaluation: passed on 07Apr2021. The patient asked what the efficacy is after one dose and if a booster will be needed since she is only protected for 6 months. Patient asked if she needed to restart the series of vaccinations if she doesn't get the second vaccine tomorrow 09Apr2021. The events ruptured blood vessel in eye, blood clot in eye, sclera looked like her eye was bleeding, eye was super red were reported as serious medically significant, and heart rate dropped as life-threatening. As reported, the events required emergency room and physician's office visit. Therapeutic measures were taken as a result of the events rupture of a blood vessel in her eye, and eye was super red. The outcome of the events reported was unknown. As per reporter, the events ruptured blood vessel in eye, blood clot in eye, and heart rate dropped were related to the covid BioNTech vaccine.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
64 2021-04-21 pain in extremity, tremor Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my lef... Read more
Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest. My chest was tight. It hurt in my neck and shoulder and chest to take a deep breath. Shortly after, I felt jittery inside & started getting chills. The backs of my legs were quaking against the chair and I got really cold. My blood pressure went up to 149/78. I also had one bout of diarrhea.
64 2021-04-24 tremor Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms las... Read more
Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation. Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported. On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
64 2021-04-24 seizure, pain in extremity, muscle twitching, tremor, weakness I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hea... Read more
I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hear it, could felt it in my chest. Then trembling; heart palpitations and it was skipping and trembling off and on; arm is sore; weird feeling; trembling; trembling, shaking and she thought she was going to have a seizure, she had no control over her muscles; muscles twitching, like if I had no control over the muscles; she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot; didn't feel good last night; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 13:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 64 years old. Medical history included cholesterol (abnormal, takes cholesterol medication 3 times a week as she gets side effects from it), cutaneous lupus (She always has to do bloodwork and goes in every 3 months), heart problem that is not major (she takes 1 medication, patient stated once in a while she sees her cardiologist every 6 months and she did get a halter monitor for 24 hours for a week and they take an average and said it wasn't as bad and knows that is a problem), 2 cervical spine surgeries, arthritis, allergic to contrast dye for CAT scans, allergy to medications (sensitive to medications), shrunk a lot because of issues, and had surgery which shrunk her because of her spine from an unknown date. Concomitant medication included atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal from 2016 and ongoing; and nadolol (CORGARD) taken for an unspecified indication from 2001 and ongoing. Patient's son got COVID on an unspecified date. Patient previously took generic atorvastatin which made her sick on an unspecified date and LIPITOR and experienced muscle weakness on an unspecified date. No additional vaccines administered on the same date of the Pfizer vaccine. No prior vaccinations. Patient never got a flu shot as she was scared. On 06Apr2021, her arm was sore which is normal. Normal side effects from the arm did not concern her, patient had no fever nothing else. She stated she came home and felt like she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot and she made sure of that. At 19:00 (also reported as 7-8pm), patient experienced her heart was skipping really bad. Patient could hear it and could felt it in her chest. Patient clarified her heart was not fast, it was more skipping, and she could feel it beating in her throat. She commented has a problem but that has not happened in a long time. Patient then experienced trembling described as lots of body trembling concerned like a seizure. She thought she was going to have a seizure. It was not chills; she had no fever or anything. The trembling came on and off. Her muscles were twitching, like if patient had no control over the muscles. Patient did not feel dizzy, it was a weird feeling. She did not feel good. On 07Apr2021 at 02:00, patient felt very tired and weak, her heart was better. About 02:00 she fell asleep. She woke up at 6:30 and she felt tired but that does not bother her. Her concern was the body trembling. She called her doctor but was not available. She was advised that it does not sound like a symptom of the vaccine. She was worried she needs to go to the cardiologist and see what is happening. She stated if it keeps happening, she will go, and she does not know if this is a side effect other people are reporting. Patient was wondering if this is a reaction as she cannot find it, one says a severe reaction is a fast heartbeat, really fast and skipping and she does not know. She expected anything, tired, headache, muscle aches but these did not happen, but she was expecting them to. Patient is wondering why her heart is doing that is it from the shot or what is going on with her which is weird, and stated the shaking, trembling of her whole body is weird. She mentioned she is sensitive to medication and gets reactions to a lot of medications. She stated this is why she was scared to get the vaccine and what the reaction was with the 1st. Patient stated her heart is a lot better than it was last night, that she feels very tired and feels unwell. She stated she took her temperature (Apr2021) and she had no fever, no nothing a little unwell, a weird feeling. Patient stated she is not trembling anymore and has no heart skipping, that went away about 2am when she fell asleep for a few hours (also reported as went away after about an hour, she had it off and on 3-4 times in an hour). Patient clarified she has not had testing done for the reported symptoms. The patient stated she is concerned and does not know what to do about second dose, which is scheduled for 04May2021. She does not if it was a reaction and stated she is very sensitive to medicine. Events did not require emergency room and physician office visit. Outcome of the event heart was skipping, tremor and palpitations was recovered on 07Apr2021 02:00 while unknown for the other events. Follow-up attempts are completed. No further information is expected. Lot number has been obtained.
64 2021-04-24 numbness passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head seve... Read more
passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head severe pain; dizziness; vertigo; nauseous; heavy sweats; my head feels very foggy; Having spots of memory issues; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 30Mar2021 11:30 (Batch/Lot Number: EM9810) as single dose for covid-19 immunization. Medical history included asthma, neuropathy, high cholesterol, and several allergies from an unknown date. The patient has no history of COVID prior vaccination. She was not COVID tested post vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number=EN6200) on 09Mar2021 12:15, on left arm for COVID-19 immunization. The patient experienced having left arm, shoulder and neck completely numb for four days since 30Mar2021, 19:00. Left lower section of her head with severe pain; she had dizziness, vertigo and was nauseous. She started having heavy sweats and passed out two times. She reported it has been a week since she had the shot and she was still dizzy and her head feels very foggy. She was also having spots of memory issues. The events were experienced on 30Mar2021, 19:00. No treatment was received for the events. The outcome of the events was not recovered from dizziness, and recovered with sequela from "Left arm shoulder and neck completely numb" on 03Ape2021, and recovered with sequelae on an unspecified date for other events..
64 2021-04-24 weakness she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness... Read more
she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness of breath; kind of fatigued; This is a spontaneous report received from a contactable consumer reporting for his wife (patient). This 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), single dose, dose 1 via an unknown route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included aortic aneurysm from 2012 to 2012, thyroid problems and headache. There was no family history. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. There were no events following prior vaccinations. Concomitant medications were not reported. In Mar2021, a week after vaccine administration, the patient was kind of fatigued. She went to the doctor in Mar2021 because she was feeling bad and they said they could hear wheezing in the stethoscope when they listened to her lungs. She was sent her for x-ray and they are waiting on the results. He said that this can also be symptoms of something going on with her thyroid and he has been trying to get her to go to the doctor. He stated she goes up and down the stairs at work and hasn't had problems but has noticed she feels weak and he has noticed she is getting more fatigued everyday. On 24Mar2021, the patient had no energy and her blood sugar has been dropping sometimes at lunch and has never had problems with it before. it is not all the time but when she comes home for lunch after she eats, it drops low. It happens sometimes at lunch, never at breakfast nor supper. In Mar2021, the patient experienced shortness of breath for the last couple of weeks, especially with the stairs. The patient went to the physician's office on 07Apr2021. Laboratory tests included blood work due to the patient's thyroid problems, blood sugar decreased and chest x-ray all on 07Apr2021. The clinical outcome of weak, shortness of breath, feeling bad, wheezing, fatigued and blood sugar dropped was unknown. No follow-up attempts are needed. No further information is expected.
64 2021-04-24 weakness slight swelling; no energy; shooting pain into her ear; She asked if this could be a lymph node situ... Read more
slight swelling; no energy; shooting pain into her ear; She asked if this could be a lymph node situation, She stated this pain has been going on since Thursday night; I started headache with my TMJ and the left side of face; I don't remember a lot of it, we're like that, I can't concentrate, around in my ear; it hurts to open my mouth really wide sometimes; bothers to swallow; just actually feeling unwell; Spot below your jaw bone in your neck; pain in my ear; I still feel very tired; messed with her TMJ on the left side; extremely tired; This is a spontaneous report of a contactable consumer (reported for herself). A 64-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration in the left arm, administered on 30-Mar-2021 at 14:45 (Batch/Lot number: ER8727) as SINGLE DOSE for covid-19 immunisation. The patient medical history includes blood pressure and cholesterol. Concomitant medications included ascorbic acid/rosa canina fruit (VITAMIN C & ROSEHIP) (started 20-25 years ago) at 1000 mg, twice a day for immune system, ongoing, calcium phosphate/colecalciferol (CALCIUM plus D) at twice a day for bone health. Vitamin E (Capsule, soft) for cancer preventive 400 iU, once a day(night) , potassium acetate (Solution for injection), 99 mg, twice a day, magnesium sulfate (Solution for injection) 400 mg, once a day (morning) for unspecified indication, multivitamin/sambucus nigra/sodium, zinc (Chewable tablet) one every other day; fish oil at 500 iU, once a day (morning) taken for cholesterol; colecalciferol (VITAMIN D3 1000) at 1000 iU, twice a day taken for an unspecified indication from 06Apr2021 and ongoing; ascorbic acid/betacarotene, calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide (PRENATAL VITAMINS) at every other day taken for Hair; pravastatin at 80 mg, once a day(night) taken for cholesterol; zinc chloride (Solution for injection) at 50 mg, twice a day taken for bone health and immunity health; acetylsalicylic acid (ASPIRIN (E.C.) at 81 mg,twice a day, loratadine at 1 tablet taken for an unspecified indication from Oct2015 and ongoing for all drug from an unspecified start date and ongoing. ibuprofen (ADVIL 12 HOUR); amlodipine besilate (Film-coated tablet) taken for blood pressure; atorvastatin calcium at 80 mg taken for cholesterol; omeprazole; fluoxetine hydrochloride (FLUOXETIN) 40 mg. It was reported that she had the first dose of the vaccine and has been having fatigue/tiredness/no energy. She stated she would compare it to if you have had surgery and go home and the anesthesia keeps kicking you. It makes her want to sleep a lot. Additionally, around her ear/jaw/TMJ area when she pushes on her neck it sends shooting pain into her ear. She asked if this could be a lymph node situation. She stated this pain has been going on since Thursday night. She asked if these symptoms are from the vaccine and if they just have to run their course/how long do they last. She took an Advil for swelling but it did not do anything. She was scheduled to get her second dose a week from today. It was also reported that Vitamin C she started taking it years ago, 20-25 years ago for immune system, Calcium plus D she started taking it years ago. She is supposed to take at least 1000. Vitamin E she started taking it many years ago. Regarding Potassium her doctor wants her to continue to take that. In her lab work last year her potassium was low. States she started taking it at least 20 years ago, longer than that, not sure. Magnesium the doctor before told her she should be taking at least 400 mg so she does when she can get it, sometimes she takes 250 mg. Caller states she started taking it 20 years ago. Multivitamin it was Normal CT Plus Equate, same as Centrum. States it had Lutein and she started taking some several years ago. Products Multivitamin was taking for general purposes, health protection. Additional Information for Fish oil states she accidentally grabbed 1000 IU so right now is taking 1000 IU. States she started about 10 years ago. States her cholesterol reporting is really good. Products vitamin d3 she was concerned she wasn't getting enough and she just started taking it a week ago. Pravastatin: Caller states it was good for other things too but the main reason was cholesterol. States she was guessing maybe in 2009, usually takes 40 mg and he raised it to 80 mg. Zinc she started taking it maybe 15 years ago. coasted aspirin she started taking it probably 3 years ago. Loratadine it was over the counter, Equate Loratadine. States it seems to work pretty well. She had a cough that wouldn't go away in the fall, the doctor told her to take one every day. Caller states from the day she got her vaccine she has been extremely tired, no energy, and is normally pretty quick on and more her feet. Sometimes she takes 3 naps a day, and still sleeps for eight hours. She is just really, really tired. She feels like when she's had surgery and came out of the hospital and anesthesia is kicking her and makes her want to sit. States it's messed with her TMJ on the left side but it continued to get worse, feels kind of like the mumps. She had the mumps as a kid and doesn't remember much about it, but discovered it wasn't it because she was able to drink milk. States she drank milk and was able to eat and drink. States it is concentrated around her left ear and sometimes aggravating to swallow, push something below her jaw bone and shoots pain into her ear. When probed for outcome she stated she was extremely tired the other day but got enough energy to vacuum and wash the dishes, but took about 3 naps a day for two days after that. pain- Stated initially she has taken Advil for the pain in the jaw. However, it does not phase it. She is not really supposed to take it, but didn't do anything when she took it a couple of times, so she thought maybe she just should not take it. States the pain is the same as it was yesterday and the day before. Confirmed outcome as persisting. Prenatal vitamin Caller states it was normal over the counter. States it is Vitamin A 4000 IU, Vitamin D 400 IU, Vitamin E 30 IU, Thiamin 1.8 mg, Riboflavin 1.7 mg, Niacin 20 mg, Vitamin B6 2.6 mg, Folic Acid 800 mcg, Vitamin B12 8 mcg, Calcium 200 mg, Iron 28 mg and Zinc 25 mg. Caller states she was taking Tylenol and Advil for pain. She took Tylenol this morning but can't say it's done anything yet. She clarified the Tylenol is 500 mg Equate Tylenol, it did not seem to be working, she took it two hours ago. Patient didn't remember a lot of it, we're like that, she can't concentrate, around in her ear, where you know TMJ is, and it hurts to her my mouth really wide sometimes, it bothers to swallow and she can push on a she did not know what it was the spot below your jaw bone in your neck and it shoots up the pain in my ear and she just wonder, and she know, Consumer further stated, 'Yes, just actually feeling unwell.' Consumer was informed about the department: consumer stated, 'Yes she thought she was talking to some one. she was told to hold on the line.' At site of vaccination: consumer stated, 'Left shoulder muscle at the top.' Probed for any Medical conditions or Concomitant medications. Outcome of the event messed with her TMJ on the left side was not recovered. Outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.
64 2021-04-25 weakness my auntie, who was trying to be supportive and to get vaccinated just passed away like this is not w... Read more
my auntie, who was trying to be supportive and to get vaccinated just passed away like this is not worse it. My auntie, passed away the next two days after she got her Pfizer Covid vaccine. My auntie, who is 65 years old, got her Pfizer vaccine the the morning of April 22 2021. She told us he was completely find on the day of the vaccine. But the next morning around 9 am, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced right after midnight at 12:04 April 25th. The reported death reason is due to Bowel Ischemia with Perforation and it has nothing to do with Pfizer vaccine that she got. But I believe it is her post Pfizer covid vaccine reaction that result in Bowel Ischemia with Perforation. My auntie lived with a very healthy life style. She walked every morning, and has a shorter walk in the evening. She has no blood pressure, no blood sugar, everything is fine with her medical check. My auntie had a kidney transplant 20+ years ago and she is on the track for monthly doctor visit. When she asked her general doctor if she could get the vaccine, her general doctor asked her to consult her kidney doctor. She then went to ask her kidney doctor and her kidney doctor call her general doctor to discuss her health conditions. Both of her doctor decided that she could take the vaccine and one of the doctor registered her for the vaccine on April 15 2021. The she nurse told her to came in for vaccine on Apr 22, and she is now death after the Pfizer vaccine. I only read about people with recent organ transplant is not recommended to take the Covid vaccine. But there is no information about people that ever had kidney transplant shouldn?t take the vaccine. My auntie, who was trying to be supportive and to get vaccinated just passed away like this is not worse it without a clear explanation. I would like you to contact health department to follow up on this case and find out the real root cause. If the vaccine is not recommended for people that ever got kidney transplant, CDC should publish the information so that there won?t be more victims. Please take necessary action ASAP. Thank you!
64 2021-04-27 unresponsive to stimuli ? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient ... Read more
? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient is sick with vomiting and diarrhea ? Friday, April 9th ? Patient is delirious and still sick with vomiting and diarrhea. She is also has pain in her stomach. An ambulance is called to take her to the hospital. The hospital determines her white blood count is elevated, indicating an infection. Blood sugar is very high ? approximately 400. Covid test is negative. She is restless upon arrival. She tries to climb out of bed continuously. She is restrained. o Saturday, April 10th ? Patient is running a fever and is in pain. She is also confused and doesn?t recognize her oldest sister. Meds are administered to handle both items. (Toradol?). Blood sugar around 200. She continuously counts and calls for Mother and Father. Patient continues to be restless o Sunday, April 11th - at request of family, a CT scan is done of her stomach and abdomen. Nothing is found. Potassium was at 3.2 (normal is 3.5) so she received an IV drip to help with potassium levels. Sugar ? 206. Later drops to 176. Patient calms down some. She is still confused and doesn?t recognize her oldest sister. ? Monday April 12th ? the hospital attempts to do an MRI, but patient panics. This is a closed MRI and her 1st husband died in one. The MRI isn?t done. ? Tuesday, April 13th ? she is asked by the doctor to state her name and wiggle her toes. She complies. Doctor orders speech therapy. She is sedated for an MRI and a CT scan. Both are successfully completed. She sleeps for the rest of the day. Blood sugar ? 274 @ 5:09pm. ? Wednesday, April 14th ? Patient was asleep all day. Most of the day she isn?t responsive when nurses come in and do things like take blood. She normally responds even if she is asleep. Around 5pm she starts to respond and make noises; she briefly opens her eyes then falls asleep. She continues to run a temperature. ? Thursday, April 15th ? Patient is asleep most of the day. She is responsive when nurses do things like take blood. A spinal tap is performed. There was mention of dementia. Hospital is sharing little information, varying from she is retreating into herself vs. something worth isolating is going on. Temp was 102.3 at 7:37, but later dropped to 99.3 without meds. Dr. (neurologist) provides an update to the family. Tests so far are negative. EEG showed sleeping brain (she was asleep during test). MRI showed nothing. Spinal tap negative so far. No infection or anything has shown up. Orders another EEG and MRI ? Friday, April 16th ? Patient tried to open her eyes. ? Saturday, April 17th ? a met code was called on her and she was moved to ICU. A circulation issue was found in right leg. Occlusion was really bad. Initially the doctor was concerned about blood clots. None were found, just swelling. Pressure was relieved. Blood pressure issues. She was put on 2 blood pressure meds, at least. She was dehydrated and acidic. Diabetic ketoacidosis was mentioned. A cytokine storm was expected. ? Sunday, April 18th ? blood pressure not stable. She was put on dialysis. Peripheral circulation was worse. ? Monday, April 19th ? she coded around 5am. Doctors were trying to save her. She passed away about 30 minutes later .
65 2021-01-03 unresponsive to stimuli Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by ... Read more
Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue
65 2021-01-04 pain in extremity She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose sto... Read more
She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose stools; sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 20Dec2020 at single dose for covid-19 immunisation. Medical history included None. There were no concomitant medications. The patient experienced loose stools on 25Dec2020, headache on 26Dec2020, achy muscles on 26Dec2020, sore arm on 20Dec2020, she thought maybe she had food poisoning bc of the weird symptoms on an unspecified date. She initially had a sore arm and the usual effects which she expected. Then, about six days into it she started having a headache and achy muscles. It all started with loose stool. She did get a COVID test because of signs of COVID. But it was negative. She thought maybe she had food poisoning bc of the weird symptoms. The headaches were bad, but they were not as bad currently. She had a loose stool that lasted a couple of days. The headaches were really mild currently. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Dec2020. Outcome of loose stools, sore arm was recovered in Dec2020, headache was recovering, achy muscles was not recovered, other was unknown.
65 2021-01-05 pain in extremity, tingling After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling... Read more
After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling, sore throat and chest tightness.
65 2021-01-05 pain in extremity stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is... Read more
stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received bnt162b2, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history included covid-19 from Apr2020 to an unknown date. She further stated that she had COVID back in April and survived. Stated that she had the pneumonia part of it and went back to work in June. The patient's concomitant medications were not reported. On an unknown date, patient was having chills since she had the shot. Stated that her arm was harsh and feels real sore. Patient wanted to know if the chills were common. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
65 2021-01-06 pain in extremity Rash; Welts; she had a very sore arm; This is a spontaneous report from a contactable nurse (patient... Read more
Rash; Welts; she had a very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid Vaccine, lot EH9099 or EH9899), via an unspecified route of administration in her left deltoid on 22Dec2020 09:32 at single dose for Covid-19 immunisation. Medical history included broken toe for 3 weeks. This was from her taekwondo and doesn't complain. No history of all previous immunization with the Pfizer vaccine considered as suspect drug. There were no additional vaccines administered on same date with Covid-19 vaccine. There were no concomitant medications. On 24Dec2020, she broke out in a rash on different parts of her body. She said the rash would come and go. She said she then had welts appear on different parts of her body and the welts would come and go. She said on the 3rd day, she had rash and welts together only on her trunk. She said on days 4, 5, and 6, she would have either a rash or welts come and go on different parts of her body. She clarified she had the rash and welts on her hands, wrists, ankles, and body. She reported that the rash and welts were serious-medically significant. On 22Dec2020, she had arm soreness and was just inconvenient and uncomfortable. She said she was not saying that what she was experiencing was related to receiving the COVID-19 Vaccine, but she doesn't know what else can be causing the rash and welts. She said she hasn't changed anything she has been eating or doing. She said she was worried about taking the 2nd COVID-19 Vaccine dose. She used Hydrocortisone 1% cream, Equate brand (reported to be expired) and took an oatmeal bath. She also took Benadryl and brand of Zyrtec called Wal-Zyr. Her height was 175cm, weight was 63kg. The rash and welts recovered on 30Dec2020; arm soreness recovered on 23Dec2020. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
65 2021-01-07 feeling hot Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; Th... Read more
Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unspecified route of administration in the left arm on 02Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine (unknown manufacturer) and multivitamins. On 02Jan2021 at 03:00 AM the patient experienced abdominal cramps, "someone's pulling my hair", headache, muscle pain, feeling sick, feeling warm with outcome of recovering. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
65 2021-01-07 tingling, tingling Sxs 5 minutes post vax with tingling in LUE, but vaccine given in RUE. Tingling is persistent. No ... Read more
Sxs 5 minutes post vax with tingling in LUE, but vaccine given in RUE. Tingling is persistent. No improvement. Persistent sxs.
65 2021-01-07 pain in extremity my hands swelled up/My hands, my feet swollen; My hands, my feet swollen, red and itchy/my hands swe... Read more
my hands swelled up/My hands, my feet swollen; My hands, my feet swollen, red and itchy/my hands swelled up, they were red and they were itchy; My hands, my feet swollen, red and itchy/my hands swelled up, they were red and they were itchy; Lymphadenopathy under both arms, red, swollen; the shoulder was swollen and the clavicle area was also swollen; sore arm; It was red like a bubbly rash like a size of pea; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 17Dec2020 17:00 at single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia. Concomitant medications included lisinopril, amlodipine besilate (NORVASC), ezetimibe (ZETIA), rosuvastatin, fexofenadine, ergocalciferol (VITAMIN D), vitamin a [retinol], vitamin c [ascorbic acid], tocopherol (VITAMIN E), thiamine (VITAMIN B1) , vitamin b2 [riboflavin], niacin, vitamin b6, folic acid, cyanocobalamin (VITAMIN B12) , biotin, pantothenic acid. Registered Nurse stated, "I received the first dose of Pfizer vaccination on Thursday, 17Dec2020 at 5 PM. I began to have an adverse reaction on Friday, 18Dec2020 at 11 PM and then until the Saturday, 19Dec2020 until after dinner I had (Incomplete sentence). You want me to break it down like what the time and what the affect was? Okay 11 PM on Friday 18th my hands swelled up, they were red and they were itchy. I couldn't get the itching to stop. Hand cream or cold water they finally subsided with cold water and I was able to get sleep. Then I woke up Saturday, 19Dec2020 at 6 AM then was my hands, my feet swollen, red and itchy. Itching was just like, I did not know what to do about it. Used cold water and that rested for about 4 hours. After that stopped I had a rash on my arms, my leg and my abdomen and it just came out of nowhere. It was red like a bubbly rash like a size of pea. You think I looked at I thought what I was going to do. I went I got a cool shower another 4 hours that subsided not completely but enough where it wasn't scary anymore, it was bearable. Closer to dinner time I had Lymphadenopathy under both arms, red, swollen then I took another 4 to 5 hours to subside. During this I have sore arm that was slightly swollen. The arm was swollen, the shoulder was swollen and the clavicle area was also swollen and that's my reaction. I work in healthcare and I was just at a point I went to work, I reported the incident and I filed a VARIS report. I talked to my administrator she said I should call Pfizer, let them know. I spoke to my primary doctor, to let him know. I just wanted to report this to someone."Registered Nurse stated, "My work place. It was offered in '(Name)' hospital (not clarified)." Treatment: Registered Nurse stated, "I took Tylenol. I took it three times and that would have been a '1000 mg' each time (Not clarified)."When probed for the Causality, Registered Nurse stated, "Yes." The outcome of the events was unknown.
65 2021-01-07 tremor shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contacta... Read more
shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease. The patient's concomitant medications were not reported. The patient previously took pneumococcal vaccine in 2020 (reported as last year) and she got a flu shot every year with no issues. She had no issues with vaccines in the past. Patient stated that she was calling about the Pfizer BioNtech Vaccine EUA. Patient stated that she had 1st dose 21Dec2020 and then she had reaction on 22Dec2020 23Dec2020 and part of 24Dec2020, she was scared to death, she was having shakes, chills, headaches, body aches. Due to this she would like to know if it is okay to get the second dose. Her second dose is schedule for 11Jan2021. On 22Dec2020 she had the general malaise, like she was punk'ed. She was home that night and got the shakes. All side effects ended on 24Dec2020 by dinner time. Patient stated that they didn't give her anything after getting the vaccine, they just gave information like this phone number, and websites. They gave stuff to read. She got the vaccine at (Hospital name). She has had no positive tests for Covid prior to the vaccine. She had 1 negative test at the end of Aug2020, and that was because she went to hospital for a total knee and they did Covid test then. She has had no antibody tests. Patient stated that she did vaccine reaction reporting on the website provided, she did the online reporting. The outcome of the events was recovered on 24Dec2020. Information on lot/batch number has been requested.
65 2021-01-08 tingling Approximately 55 mins after vaccine was given, my lips and the end of my nose started to tingle. The... Read more
Approximately 55 mins after vaccine was given, my lips and the end of my nose started to tingle. The feeling intensified over 15 mins until it felt like a Novocain shot from the dentist when it starts to wear off. I took a Cetirizine 10 mg tab and the tingling completely resolved within an hour. No swelling of my mouth/ tongue or difficulty swallowing .
65 2021-01-08 facial pain, pain in extremity Pain Right Arm Headache Pain r side of face and r eye
65 2021-01-10 burning sensation, numbness Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness... Read more
Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness of the left side of the face and headache on the left side and part of the tongue; The left side of my body, like burning (ankle, elbow); The left side of my body, like burning (ankle, elbow); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular at left arm on 30Dec2020 11:30 at SINGLE DOSE for COVID-19 immunization. Medical history included known allergies to Uva roja. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included atorvastatin (LIPITOR) and fexofenadine hydrochloride (ALLEGRA). The patient previously took titanium and experienced allergies. On 30Dec2020 , the patient experienced numbness of the left side of the face and headache on the left side and part of the tongue. The left side of patient's body, like burning (ankle, elbow). No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered on unspecified date. Information on lot/batch number has been requested.
65 2021-01-10 tenderness Swollen neck starting below right ear down jaw line. Tenderness and full feeling
65 2021-01-10 feeling hot, pain in extremity Symptoms started on 1/16/21 with redness, swelling, pain, warm to the touch, spreading down arm.
65 2021-01-10 numbness approximately 10 minutes after taking the covid vaccine client started c/o headache, tightness in he... Read more
approximately 10 minutes after taking the covid vaccine client started c/o headache, tightness in her throat, and slight difficulty breathing. She self administered her albuterol inhaler, and was started on O2 AT 4 L.at 10:16 she said that the symptoms were all gone. at 10:24 she said her throat tightness had returned, she was offered benadryl and epinephrine which she refused bc she said she had to drive home. she took benadryl po when she got home.when she got home, the left side of her face became numb, she had a headache and burning eyes. The next day she still had a little numbness on the left side of her mouth. no problems since.
65 2021-01-11 pain in extremity Joint pain/Her knee really hurts; Muscle pain; Headache; Chills; Her back hurts, especially at night... Read more
Joint pain/Her knee really hurts; Muscle pain; Headache; Chills; Her back hurts, especially at night/Her lower back hurts; Her neck is really bad; Her hands hurt; mild arthritis; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via an unspecified route of administration in left upper arm on 30Dec2020 15:20 at single dose for covid-19 immunization in hospital and vaccine was not administered at Military Facility. Medical history included car accident where she broke her neck, usually she is hot all the time, she is a health person and she went the whole year without a cold. There were no concomitant medications. Prior vaccinations included regular flu shot, but she thought it was longer than 4 weeks. There was no vaccines was administered on same date of Pfizer bnt162b2. The patient clarified the side effects she was experiencing as: joint pain, muscle pain, occasional headache, and chills that were coming in and out. The patient explained she got the vaccine on 30Dec2020. The patient started to have the joint pain 3-4 days after getting the vaccine in Jan2021. She stated it was still uncomfortable. Her back hurts, especially at night. It was like all the time, but more so at night. Her neck was really bad. Pretty much every place she had mild arthritis she hurt. She felt it mainly in her neck. She mentioned historically she was in a car accident where she broke her neck. The pain in her neck was almost to the point where she was when she was initially healing from the accident. Her hands hurt. Her lower back hurts. Her knee really hurts. It all hurt more than normal. The muscle pain started 3-4 days after she got the vaccine in Jan2021. The muscle pain was sporadic. She would feel it a little bit and then it went away and then she would feel it again. The headache started within the last 2-3 days in Jan2021. She thought it had gone away for the most part. She just got an occasional headache when her neck hurt a lot. It kind of went with the neck hurting. The chills started around 02Jan2021 or 03Jan2021. Usually she is hot all the time. However, lately she had been feeling chills. She was not sure if it was due to weather or if she was really having chills. This is unusual for her. She stated the chills was kind of the same or maybe a little better. She had a COVID test done on 26Dec2020 which was negative. She had to have the test done for pre-surgical reasons. The adverse events did not require a visit to emergency room or physician office. The outcome of joint pain/knee really hurt, muscle pain and chills were not resolved, outcome of rest events were unknown.
65 2021-01-11 tingling Palm tingling enough to wake from sleep Sore arm Site injection pain
65 2021-01-12 hot flush, facial paralysis Patient states that a couple of minutes from receiving the vaccine she got a hot flash. About 10 min... Read more
Patient states that a couple of minutes from receiving the vaccine she got a hot flash. About 10 minutes after the vaccine the patient states that her mouth and face started drooping on left side. She took a drink and it felt weird.
65 2021-01-12 tingling lips and nose were tingling; lips and nose were tingling; She has heard that you feel sicker after t... Read more
lips and nose were tingling; lips and nose were tingling; She has heard that you feel sicker after the second vaccine and she is afraid; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, intramuscular (left arm) on 06Jan2021 at single dose for covid-19 immunisation. Medical history included blood pressure (abnormal) and blood cholesterol (abnormal) from an unknown date. Concomitant medication included lisinopril (LISINOPRIL) for Blood pressure for 3 years and adenosine (TRICOR) for cholesterol for 6 months; from unspecified dates and ongoing. On 06Jan2021, 50 minutes after the dose, her lips and nose were tingling described as tingling like when a dentist puts your mouth to sleep. It lasted about an hour. She took Cetirizine which she is sure helped. Within the hour of taking Cetirizine it was gone/resolved. She is afraid for the second vaccine. She has heard that you feel sicker after the second vaccine and she is afraid because it is her mouth. She also stated she took Ibuprofen an hour before hand to ward off evil (as reported). She took 400 mg. She asked if there is information on tingling and if it would be worse after the second dose. Outcome of the events lips and nose were tingling was recovered while unknown for "She has heard that you feel sicker after the second vaccine and she is afraid". Information about batch/lot number has been requested.
65 2021-01-14 flushing Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 min... Read more
Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 minute wait post covid 19 vaccine. Patient complied. After initial 30 minute wait, patient complained her mouth was dry and asked for water. Water provided, patient denied other symptoms. Based on history patient advised to wait another 20 minutes, and notify staff prior to leaving. 5-10 minutes later husband alerted nurse that she was feeling worse. Upon assessment, patient complained of swollen tongue, and difficulty swallowing. Adverse reaction protocol initiated. Client laid on cot, vitals taken, EMS called. Tourniquet applied above vaccination site, distal pulse check every 5 minutes. Nasal cannula, 4L applied. Blood pressure high, patient became flushed, complained of worsening in swallowing. Epi pen given in right thigh, Benadryl given IM in right deltoid. EMS arrived and took over care. Patient transported to hospital.
65 2021-01-14 weakness Tempature, body aches and feeling weak
65 2021-01-15 pain in extremity LEFT ARM SORENESS AND NECK PAIN.
65 2021-01-17 pain in extremity Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccinatio... Read more
Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccination. States she had these same symptoms up to 3 days after vaccine but they resolved. She is also reporting onset of headache, joint pain yesterday (9 days post vaccine) and low grade temp today (10 days post vaccine).
65 2021-01-17 tremor, weakness, feeling cold TOOK TYLENOL SINUS HEADACHE AT 2PM ON FRIDAY. WOKE UP FRIDAY AT MIDNIGHT WITH CHILLS, HEADACHE AND S... Read more
TOOK TYLENOL SINUS HEADACHE AT 2PM ON FRIDAY. WOKE UP FRIDAY AT MIDNIGHT WITH CHILLS, HEADACHE AND SHAKING. TOOK TYLENOL SINUS. REPEATED TYLENOL SINUS EVERY 4 HRS FOR HEADACHE. ON SAT AND SUNDAY WAS WEAK--MONDAY FELT BETTER.
65 2021-01-17 pain in extremity, weakness chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous repo... Read more
chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiration date not reported), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Medical history included 'Blood pressure'. Concomitant medication included doxorubicin hydrochloride (LIPISOL) for blood pressure. The patient reported that on 08Jan2021 (Friday), she had the COVID vaccine. On 09Jan2021 (Saturday), her arm hurt, she had body aches, and weakness. She also had a headache Saturday night. On 10Jan2021, she started getting chest congestion and her throat was hurting. When she was spitting out it felt like her throat was scratchy. Patient further reported that her arm does not hurt now. It still bothers her a little if she touches it, but doesn't if she doesn't touch it. Patient also reported that she does not have too much body aches now. She had a good dinner and took two of the 600mg Ibuprofen. It helped her. It still hurts a little. Patient reported that her weakness feels a little better. No fever and she has been checking her temperature. Patient clarified that her throat wasn't bothering her last night, but today it was bothering her. It was the bottom of her throat. She was supposed to go back on the 29th to get the other part. The patient was recovering from arm hurt, body aches, and weakness; has not recovered from chest congestion; and unknown outcome for the remaining events.
65 2021-01-18 feeling hot, feeling of body temperature change, pain in extremity was burning up; Sore arm; Throbbing headache; I was hot, I was cold; Fever; Chills; This is a sponta... Read more
was burning up; Sore arm; Throbbing headache; I was hot, I was cold; Fever; Chills; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 07Jan2021, at single dose, for COVID-19 immunization, in the hospital. Medical history included blood pressure high and high cholesterol. The patient reported "I just got my second Pfizer Vaccine (clarified as BioNTech Covid 19 vaccine) yesterday (07Jan2021) and I just wanted to call to report the side effects that I have because they told me you should specially after the second one. And I have had fever, headache, and chills. So, I just wanted to report this". When asked about the event start date, the patient stated, "I went to sleep, I got the shot yesterday morning on early (07Jan2021). And then I was fine except for the sore arm. And then I woke up in the night. I fell asleep fine; I woke up through the midnight and it was burning up. So, I took my temperature. So, I'd say about 3 am (08Jan2021)". When asked if the patient was still experiencing the events, the patient stated, "Little bit because I had also throbbing headache and I was hot, I was cold. I did take Tylenol (treatment) and I did think that it started to help a little bit. Because I did got, my fever has gone down." The outcome of the events was recovering.
65 2021-01-19 feeling hot Felt hot; chest tightness; nausea; metallic taste in her mouth
65 2021-01-19 feeling cold passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe head... Read more
passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP. A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 07Jan2021 11:00 at single dose for Covid-19 immunisation . Medical history included rubber sensitivity (Latex). The patient's concomitant medications were not reported. On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out with outcome of recovered , dizzy with outcome of recovered , hit the ground with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills with outcome of recovered , tired with outcome of recovered , severe headache on with outcome of recovered , vomiting twice with outcome of recovered , cold with outcome of recovered. The reporter stated the patient attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out dizzy and falling down and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-01-20 flushing Flushed face; Severe nausea; This is a spontaneous report from a contactable consumer (patient). A ... Read more
Flushed face; Severe nausea; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 11Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included hypertension and gastrooesophageal reflux disease. The patient previously took lisinopril and experienced drug hypersensitivity and anaphylactic reaction, diphenhydramine (BENADRYL) and experienced drug hypersensitivity and urticaria. Concomitant medication included propranolol hydrochloride (PROPRANOL), chlorthalidone (unknown manufacturer), rabeprazole sodium (ACIPHEX), vitamin c (unknown manufacturer). The patient experienced flushed face and severe nausea on 11Jan2021 13:00 with outcome of not recovered. It was unknown f treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the Batch/Lot number has been requested.
65 2021-01-21 difficulty speaking Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; ... Read more
Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; feeling of swelling and burning in throat; slight difficulty swallowing; hoarseness; pruritus
65 2021-01-21 pain in extremity Arm soreness developed morning after vaccine, still present on D2
65 2021-01-21 flushing, tingling Has a flush feeling over entire body, then broke out in a sweat. Felt prickly (pins and needles] in... Read more
Has a flush feeling over entire body, then broke out in a sweat. Felt prickly (pins and needles] in my arms on and off all day.
65 2021-01-21 weakness Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) ap... Read more
Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) approximately 5 minutes after receiving the 2nd dose of the COVID vaccine. The patient was taken to the emergency department for further workup. In the ED, the patient was given acetaminophen and ondansetron with resolution of all symptoms except generalized weakness and fatigue. Workup in the ED was negative, and the patient was discharged home.
65 2021-01-21 weakness Patient began to experience nausea, dizziness, generalized weakness, and an elevated blood pressure ... Read more
Patient began to experience nausea, dizziness, generalized weakness, and an elevated blood pressure (209/101) approximately 5 minutes after receiving the 2nd dose of the COVID-19 vaccine. The patient was taken to the emergency department for further workup. In the ED, the patient was given acetaminophen and ondansetron. Workup was negative, and the patient was discharged home.
65 2021-01-21 numbness Patient reported feeling numb, dizzy, and short of breath. Assessment revealed a thready pulse. Pat... Read more
Patient reported feeling numb, dizzy, and short of breath. Assessment revealed a thready pulse. Patient complained of tightness in her throat. Epi administered by observing nurse.
65 2021-01-21 migraine Severe migraine Brain fog Lymph node under left arm is extremely painful to touch Body aches
65 2021-01-22 discomfort Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and... Read more
Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and outside, throat tightening, lungs heavy , not, and tightening. Body heavy. Mind disconnected. Happened with in 5 minutes of injection.
65 2021-01-24 weakness I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, e... Read more
I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, exhaustion for 4 days. shot given on Wednesday and not able to shower or get up till Sunday Second shot symptoms more severe. Headache, sick to my stomach vomited, and exhaustion same thing shot given on Wednesday and not able to get up till Sunday. First 24 hours of the second shot I was so weak I good not get up even to get a drink.
65 2021-01-25 weakness About 15 hours later headaches, chills, congestion, weakness, body aches
65 2021-01-25 weakness DAY AFTER VACCINATION, HAD LOW GRADE FEVER, FATIGUE, AND WEAKNESS
65 2021-01-25 feeling hot Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nausea... Read more
Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) intramuscular in the right arm on 11Jan2021 07:30 AM at a single dose for Covid vaccine. Medical history included high BP. The patient had no known allergies. Concomitant medications included lisinopril, colecalciferol (VITAMIN D), vitamin B complex (B COMPLEX), calcium, and cetirizine hydrochloride (ZYRTEC) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient experienced headache not too bad but hot nauseated 24 hours after injection on 12Jan2021 08:00 AM. Treatment was not received for the events. The patient had no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the events was not recovered.
65 2021-01-25 facial pain I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain... Read more
I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes.; I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes.; I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes.; I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes.; I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes.; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO146), via an unspecified route of administration on right arm on 23Dec2020 12:00 at a single dose for covid-19 immunisation. Medical history included hypertension, osteopenia, hypercholesterolaemia and migraine; all from an unknown date. Patient is not pregnant. The patient had her second dose of pneumonia vaccine on 01Dec2020 that was administered on her right arm for immunization. Concomitant medications included calcium, alendronate sodium (FOSAMAX), losartan, meloxicam and simvastatin; all were taken from an unspecified date for an unspecified indication. The patient previously took naproxen sodium (NAPROSYN) and experienced drug allergy. On 28Dec2020 12:00, the patient developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes. The patient did not received any treatment for the reported events. The patient underwent lab tests and procedures which included covid-19: negative on 28Dec2020, on 30Dec2020, on 04Jan2021 and on 08Jan2021 (nasal swab) while on 11Jan2021 (nasal swab) had pending result. The outcome of the events was recovered.
65 2021-01-25 pain in extremity Low fever, Chills, Body aches, Sore arm, Mild head ach
65 2021-01-26 tingling STATES AFTER INJECTION FELT SOME TINGLING IN FINGERS IN BOTH HANDS NO OTHER SYMPTOMS OBERVED FOR 30... Read more
STATES AFTER INJECTION FELT SOME TINGLING IN FINGERS IN BOTH HANDS NO OTHER SYMPTOMS OBERVED FOR 30 MINUTES DISCHARGED DENIES ANY COMPLAINTS
65 2021-01-27 pain in extremity Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas... Read more
Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas; Fever; Tightness in jaw; Sore arm and muscles; Sore arm and muscles; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 12Jan2021 08:40 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness in jaw within one hour after vaccination and noticed on her way home, sore arm and muscles on 12Jan2021, fever last night (13Jan2021). Her body was aching from her groin and going down, especially in both thigh areas on 13Jan2021. It woke her up. She didn't take anything for it. She laid there until she went back to sleep. It was gone now. The patient also experienced a headache on an unspecified date and chapped lips on 14Jan2021. The outcome of the events chapped lips and headache was unknown, tightness in jaw was not recovered, body is aching from her groin and going down, especially in both thigh areas were recovered while other events were recovering.
65 2021-01-27 weakness Immediately following vaccination, the patient became dizzy, weak, and suffered a syncopal episode. ... Read more
Immediately following vaccination, the patient became dizzy, weak, and suffered a syncopal episode. Blood pressure was noted as hypotensive at 70/60. IV fluids were administered by EMS and patient was transported to the Hospital emergency department for evaluation. After lying flat and receiving IV fluids, Patient's BP improved to 136/79 per triage note. Patient was discharged from the ED with vasovagal syncope and instructed to submit VAERS report.
65 2021-01-27 pain in extremity Sore arm. body aches, low grade fever, headache,
65 2021-01-27 inability to speak she couldn't get the words out properly when speaking with a client; she was looking at her husband ... Read more
she couldn't get the words out properly when speaking with a client; she was looking at her husband and she couldn't see about a quarter of his face; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, via an unspecified route of administration in the upper left arm, on 05Jan2021 08:45 at a SINGLE DOSE for covid-19 immunization. Patient had no other relevant medical history. There were no concomitant medications used. Historical vaccine included Flu vaccine. On 10Jan2021 11:51, the patient experienced that when she was looking at her husband and she couldn't see about a quarter of his face. About 10 minutes later (12:01), she couldn't get the words out properly when speaking with a client. Within five minutes or so, everything was back to normal. Outcome of events was recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
65 2021-01-28 cold sweat, tremor Patient vaccinated @ 10:14 on 1/29/2021 then placed in observation for 30mins. At 10:19 c/o dizzines... Read more
Patient vaccinated @ 10:14 on 1/29/2021 then placed in observation for 30mins. At 10:19 c/o dizziness, shortness of breath, nausea, shaking. patient is clammy & pale, a&o x4, lungs clear bil all lobes, pulse normal, cap refill <3, V/S @ 10:20, b/p 140/90, r22, p72, t 99.7, unable to obtain o2 stat via pulse ox r/t pt shaking. Patient states that temp normal runs 96.8. Monitoring pt while obtaining health history. 10:40 V/S t 99.8, b/p 160/74, p113, 02 88% on RA, r 24, o2 placed on pt 15l nonrebreather, o2 91%. 10:50 EMS arrived, pt a&ox4, no change in condition, V/S 100/60, 100% on 15L nonbreather, p90, r22. 10:55 still nausea, 4mg sublingual zofran given. 11:04 pt transferred to stretcher with assisit, a&Ox4, V/s 132/69, p80, 94% o2 on 10l via nasal cannula, r26 co2 33. pt transferred via ambulance, pt request to be taken to hospital.
65 2021-01-28 flushing Redness and flushing to face, neck and chest beginning 45 mins after receiving the vaccine. Took be... Read more
Redness and flushing to face, neck and chest beginning 45 mins after receiving the vaccine. Took benadryl with good effect. Symptoms completely resolved by the following morning.
65 2021-01-28 cold extremities Starting the next night my feet wer freezing when trying to lie down at night, could not get them wa... Read more
Starting the next night my feet wer freezing when trying to lie down at night, could not get them warm unless wrapped in a blanket which is not normal for me, still ongoing but less intensity today 1-29 Ongoing fatigue and having to nap daily and if working go home and going to be early and sleeping about 10-11 hours a night, again not normal Improving daily but still ongoing
65 2021-01-29 flushing numb lips with tightness and itching in throat, flushing
65 2021-01-31 pain in extremity Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing th... Read more
Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing that evening, headache, sore arm. Took Tylenol.
65 2021-01-31 tingling Paresthesias of left hand, general malaise, fatigue, ? HTN urgency ? however missed HTN med doses at... Read more
Paresthesias of left hand, general malaise, fatigue, ? HTN urgency ? however missed HTN med doses at the time of evaluation
65 2021-02-01 tingling Very strong pins/needles throughout body; This is a spontaneous report from a contactable consumer r... Read more
Very strong pins/needles throughout body; This is a spontaneous report from a contactable consumer reporting for self. A 65-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Jan2021 (at the age of 65-years-old) 17:00 as a single dose, left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, arrythmia, high sugar, and penicillin allergy. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included metoprolol succinate (TOPROL), lisinopril, amlodipine, and esomeprazole sodium (NEXIUM). On 16Jan2021 at 10:00, the patient experienced very strong pins/needles throughout body. There was no treatment provided for the event. The outcome of the event very strong pins/needles throughout body was not recovered. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
65 2021-02-01 pain in extremity, numbness, speech disorder hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in h... Read more
hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-02-01 pain in extremity headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer report... Read more
headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient (not pregnant), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration, on left arm on 16Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included Diverticulosis, hypothyroid, osteoarthritis, vitiligo, psoriasis, anxiety/depression, known allergies: Iodine, sulfa, bivalve shellfish, garlic, onions. Concomitant medications included first dose of pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 23Dec2020 on left arm, celecoxib (CELEBREX), sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL). The patient experienced fatigue, sore arm the day after vaccine was administered on 17Jan2021. Two days after administration on 18Jan2021, patient experienced fatigue, headache, nausea. No treatment received for all events. The outcome of the events were resolving.
65 2021-02-03 weakness Around 1:00 am on the 2/3/21 I got a fever and was shivering. When I got up I was very weak and ti... Read more
Around 1:00 am on the 2/3/21 I got a fever and was shivering. When I got up I was very weak and tired. I started with a headache in the evening of 2/2/21
65 2021-02-03 pain in extremity Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a c... Read more
Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ 1685), via an unspecified route of administration in the left arm on 20Dec2020 08:00 at a single dose for covid-19 immunization. Medical history included prediabetes, spinal stenosis of right back, allergies in penicillin, sulfa and yellow jacket venom. Concomitant medication included gabapentin, metformin, paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc and vitamins. On 20Dec2020 20:00, 12 hours after vaccine administration, the patient experienced blurred vision, fatigue, dizziness, tachycardia and arm soreness. The patient did not receive treatment for the events. The patient had not tested positive for COVID post vaccination. The outcome of the events was recovered on unspecified date.
65 2021-02-03 tenderness Breakout in fever blisters all over my mouth; usually happens when my body is under stress like that... Read more
Breakout in fever blisters all over my mouth; usually happens when my body is under stress like that; local tenderness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot EL3249), via an unspecified route of administration, on 12Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization.The facility where COVID-19 vaccine was administered was at a hospital. Medical history included pain and anxiety depression from an unknown date and unknown if ongoing. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL]) for pain and desvenlafaxine succinate (PRISTIQ) for anxiety and depression. On Jan2021, the patient experienced local tenderness and on 18Jan2021, the patient experienced breakout in fever blisters all over her mouth, stating this usually happens when her body is under stress like that. Therapeutic measures were taken as a result of local tenderness and breakout in fever blisters all over my mouth (anti-fever blister type medicine). The clinical outcome of the events fever blisters all over her mouth and local tenderness were unknown. No follow-up attempts are possible. No further information is expected.
65 2021-02-03 pain in extremity Got tested and came positive after receiving first vaccine; Got tested and came positive after recei... Read more
Got tested and came positive after receiving first vaccine; Got tested and came positive after receiving first vaccine; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events in two patients. This is the first of two reports. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included vitamins nos. It was reported that both the patient and her husband received the Pfizer Vaccine on 10Jan2021; and they had reaction to it. They both both had bad arm swelling and pain. Her was worst she couldn't even lift or move her arm. At first, they just thought it was a reaction as they read reactions could be and then she started to get small cough but by Friday, her husband went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday, they both went and got tested, they did the rapid and they did what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. So, she thought they need to know that they got sick and it was after the vaccine. The patient needed to ask a question as they were supposed to go for their second vaccine on 31Jan2021 and do they do it even though they got sick. They knew they were claiming that they can't get sick because of the vaccine but it's very ironic that they did get this. They had been following CBC guidelines, both her husband and the patient because they are older and they wear mask all the time and they did everything they needed to and they could not understand how they got this. The patient underwent lab tests and procedures which included Rapid and PCR: positive in Jan2021. Therapeutic measures were taken as a result of "bad arm swelling and pain; worst she couldn't even lift or move her arm" which included treatment with Tylenol. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092094 same reporter and drug, similar events in a different patient
65 2021-02-04 feeling cold, tingling About 1/2 hour of the vaccination, I felt mild tingling of the lips. Very gradually, that got worse... Read more
About 1/2 hour of the vaccination, I felt mild tingling of the lips. Very gradually, that got worse (over the nest few hours) and I had tingling of hands and feet. I gradually developed facial swelling (my lips were enlarged and felt firm, as did my nose). I checked my pulse ox, and it remained above 97%. I never had rash or trouble breathing. But about 5 hours after receiving the immunization, I took some Benadryl, and over about 1/2 hour I could feel that things were improving. Over the next 24 hours I took Benadryl again two times, due to return of the tingling sensation of my lips. I also felt very cold, and had a hard time getting warm. This also improved with the Benadryl.
65 2021-02-04 weakness Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shor... Read more
Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shortness of breath with symptoms worsening as time went on. Pt remained afebrile. Pt presented to the ED and was diagnosed with a Pulmonary Embolism.
65 2021-02-04 pain in extremity a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 ... Read more
a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 hrs; temp of 100.6; body aches; nausea; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3302), via an unspecified route of administration in the left arm on 21Jan2021, at 08:00 a single dose for covid-19 immunization. Medical history included breast cancer stage one from Oct2019. There were no allergies to medications, food, or other products. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), benazepril (MANUFACTURER UNKNOWN). The patient experienced the following event on 21Jan2021, at 03:00: a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 21Jan2021. Details were as follows: a few hours after injection, the patient noted that her arm was unusually sore past elbow chills that lasted for about six hours. Temp of 100.6 body aches nausea. It was reported that treatment was not received for the events; however she used a heating pad to relieve the pain. The events were non-serious. No diagnosis of COVID-19 prior to vaccination was noted. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events, a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea was recovered in Jan2021.
65 2021-02-04 pain in extremity fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous... Read more
fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received second dose of bnt162b2 (BNT162B2, LOT: EL 3248), via an unspecified route of administration from on 10Jan2021 10:30 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history included Prediabetes, spinal stenosis of right back, right hip pain, known allergies: Penicillin, sulfa, yellow jacket venom. No pregnant. The patient had no covid-prior-vaccination. The patient Historical Vaccine included COVID 19 for covid-19 immunisation at 65 years old, product=COVID 19, brand=PfizerBioN Tech, lot number=EJ 1685, administration date=20Dec2020, administration time=08:00 AM, vaccine location=Left arm; and After 12 hours (08:00 PM) experienced Blurred vision, fatigue , dizziness, tachycardia, arm soreness, after first vaccine 20Dec2020. Concomitant medication included gabapentin (GABAPENTIN), metformin (METFORMIN), paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc (ZINC). The patient experienced fatigue and arm soreness, and flair up of right hip pain after had received a epidural right hip block 5 days before 2nd injection since Jan2021. No treatment received. The event recovered in Jan2021. No covid-tested-post-vaccination.
65 2021-02-05 feeling cold Evening following injection and next day: Mild headache was treated with acetaminophen. Slightly ... Read more
Evening following injection and next day: Mild headache was treated with acetaminophen. Slightly chilled. Next day: fatiqued.
65 2021-02-05 migraine Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued ... Read more
Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued until evening but were not as bad in afternoon. Low grade fever, migraine and nausea began around 2:00. Woke up with migraine at 6:30 am on February 6 which has subsided since taking sumatritam. Some fatigue and lethargy this morning but ok otherwise
65 2021-02-05 pain in extremity, weakness Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection giv... Read more
Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection given and a wave of pain and nausea and malaise overwhelmed me. I passed completely out still lying in bed (so out that I wet myself in bed) and gradually came to, still feeling horrible. Got up, changed clothes, and major chills when I returned to bed. Around 6am I felt nauseous, got up to vomit, but instead passed completely out on the bathroom floor for about 15 minutes. Remainder of day I felt very stiff, low energy and slightly woozy. By afternoon, energy was returning (I vacuumed the house). Minimal pain in arm this time compared to previous.
65 2021-02-07 tremor HA over R-eye, dizzy, shaky, no breakfast, no BS check., BS @ 14:18: 294
65 2021-02-08 weakness, numbness All my stroke symptoms returned immediately; numbness on left side of face, left hand, left foot, le... Read more
All my stroke symptoms returned immediately; numbness on left side of face, left hand, left foot, left chin; Weakness; pain; all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin. Weakness and pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PF EL3249), via an unspecified route of administration in arm left, on 16Jan2021 12:00 PM at single dose for COVID-19 immunisation. Medical history included massive stroke in Jul2018, left side effected; numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago; asthma. Patient was allergic to shrimp, lobster. Patient is not pregnant. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Concomitant medications included Losartan, Amlodipine, acetylsalicylic acid (ASPIRIN), Atorvastatin, Montelukast. Patient was previously allergic to codine, tetracycline. On an unspecified in Jan2021 (reported as 15Jan2021, pending clarification), all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago returned immediately and had not subsided 2 weeks later. Patient received treatment, physical therapy continued for stroke symptoms. AE resulted in doctor or other healthcare professional office/clinic visit, the reported seriousness criterion is disability. Outcome of the events was not recovered.
65 2021-02-08 facial paralysis Awoke with symptoms of Bells Palsy - droopiness on left side of face, especially mouth, unable to li... Read more
Awoke with symptoms of Bells Palsy - droopiness on left side of face, especially mouth, unable to lift left side
65 2021-02-08 cold sweat I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horr... Read more
I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horrible body pain. No temp. I missed 6 days of work I was so sick.
65 2021-02-08 tingling Second COVID vaccine on 1/14/21 - The patient is received her second dose of Pfizer vaccine at Hosp... Read more
Second COVID vaccine on 1/14/21 - The patient is received her second dose of Pfizer vaccine at Hospital. Post dose she experienced intermittent sensation of tingling on left posterior neck area with no paresthesia and difficulty lifting bilateral extremities. Three days after administration of the vaccine she began noticing weakness in her legs that eventually progressed to her arms bilaterally. She developed pitting edema and SOB. Per infectious disease MD, the main suspicion is for GBS Guillain-Barre Syndrome given exam findings. Pt's weakness and resulting inability to ambulate may have pushed pt into CHF exacerbation. Patient received 3 days of IVIG which was discontinued due to worsening mental status. Naranjo scale score of 2 indicates possible ADR.
65 2021-02-08 feeling cold, weakness She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energ... Read more
She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
65 2021-02-09 feeling hot Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155... Read more
Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155/94; pulse rate up; This is a spontaneous report received from a contactable consumer (the patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL 9261), via an unspecified route of administration in the left arm on 21Jan2021 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, indoor and outdoor allergies, and allergies to latex and contrast. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously took and had allergies to: amoxicillin/ clavulanic acid (AUGMENTIN), sulfamethoxazole/ trimethoprim (BACTRIM), levofloxacin (LEVAQUIN), and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Within 5 minutes of receiving the dose on 21Jan2021, at 15:45 (as reported), the patient's face and chest became bright red, felt very hot, sinus pressure increased. The EMT's took her blood pressure- was up 155/94, and her pulse rate was up (21Jan2021, 15:45 (as reported)). Her temperature and blood sugar were within normal limits (21Jan2021). The patient did not receive any treatment for the events. The clinical outcome of face and chest became bright red, felt very hot, sinus pressure increased, blood pressure was up 155/94, and pulse rate up was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
65 2021-02-09 unresponsive to stimuli Patient found unresponsive in room with no pulse or respirations. She was pronounced dead by parame... Read more
Patient found unresponsive in room with no pulse or respirations. She was pronounced dead by paramedics at 06:25am on 2/5/2021.
65 2021-02-09 burning sensation Shot given 10:19pm on 2/6/21. Noticed rash on 2/8/21 11:55am. Rash was bilateral on face along mad... Read more
Shot given 10:19pm on 2/6/21. Noticed rash on 2/8/21 11:55am. Rash was bilateral on face along madibles from TMJ to about 1" from lips and was 2" superior from jaw line towards the eyes. Rash was very red over skin area with multiple darker spots and by 2/7/21 those spots appeared open though no blisters or pustules were seen. Rash had burning sensation which was relieved by Vaseline. Once doctor was seen (PA), Tacrolimus ointment was prescribed BID. Rash no longer burns 2/9/21 pm and it appears to be resolving. Spots are still evident but erythemic area is gone.
65 2021-02-09 pain in extremity Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm wa... Read more
Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program. A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
65 2021-02-10 pain in extremity Severe pain in left arm muscle-icing, Tylenol, Advil Headache Nausea, vomitX1
65 2021-02-14 tingling, numbness, burning sensation neuropathy; Day 4 after injection, heat sensitivity in hands and feet; tingling in hands/feet; sharp... Read more
neuropathy; Day 4 after injection, heat sensitivity in hands and feet; tingling in hands/feet; sharp burning needles sensation up arms and legs; Tips of fingers and toes were numb and felt swollen; Tips of fingers and toes were numb and felt swollen; Hands then started peeling, palms became thickened and rough; This is a spontaneous report from a contactable healthcare professional, the patient. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the right arm on 22Dec2020 at 08:30 (at the age of 65-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included A-fib (atrial fibrillation), GERD (gastroesophageal reflux disease) and osteoporosis. Concomitant medications included atenolol, calcium, acetylsalicylic acid (ASPIRIN), famotidine (PEPCID) and omeprazole. Past drug history included known allergies: fexofenadine (ALLEGRA) and codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Dec2020, day 4 after injection, the patient experienced heat sensitivity in hands and feet, followed by tingling in hands > feet, with sharp burning needles sensation up arms and legs. Heat sensitivity continued. Tips of fingers and toes were numb and felt swollen for several days, while neuropathy continued. Hands then started peeling, palms became thickened and rough. For the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling an emergency room visit and physician office visit was required. Unspecified treatment was provided for the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling. The outcome of the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling was recovering. Since the vaccination, the patient has been tested for COVID-19. Nasal Swab on 13Jan2021 was negative and on 19Jan2021 was negative. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of neuropath, cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-02-16 pain in extremity, nerve pain About 10 hours after vaccination a headache started. Then my joints started hurting almost like a ne... Read more
About 10 hours after vaccination a headache started. Then my joints started hurting almost like a nerve was firing off but only at the joints, ie knee, shoulder, toes, ankle, fingers, toes, etc. It would happen randomly. Never all joints at once. Very weird. Continued throughout the night making it difficult to sleep. In the morning, at 7 am, got up out of bed. Took 2 Advil. At 10:20 I still have the joint happening but not as frequent and not as strong. I still have the headache. It hasn't changed.
65 2021-02-17 weakness, migraine trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feelin... Read more
trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feeling very shaky and very weak; feeling unwell; alternating slow heartbeat and fast heartbeat; a weird feeling in her head like pressure but not a headache/pressure feeling in my head; they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction.; This is a spontaneous report from a contactable consumer. A 65 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 31Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included allergic to shrimp, lupus anticoagulant syndrome, chronic kidney disease and antiphospholipid syndrome. Concomitant medications included amlodipine, HCTZ, losartan, acetylsalicylic acid (ASPIRIN (E.C.) and atorvastatin calcium (LIPITOR ORIFARM). The patient informed that immediately after receiving the injection she felt a lump in her throat and could not swallow, still present now. Patient also informed that after vaccination she was having a very high blood pressures, feeling very shaky and very weak, a weird feeling in her head like pressure but not a headache, trouble sleeping because of the pressure feeling in my head, feeling unwell and alternating slow heartbeat and fast heartbeat. Patient also reported she had scheduled an allergist appointment and they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction. At the time of the reporting event outcome was unknown.
65 2021-02-21 pain in extremity Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even ... Read more
Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even soles of feet. Difficulty sleeping that night. Could not sleep on left side for about 3 days. Knees ached, difficulty walking.
65 2021-02-21 weakness I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over a... Read more
I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over all my body (joint/muscle pain) that started about 10 PM the night. I woke up Saturday morning with a bad headache, felt like I was pass out, I had chills. Saturday afternoon I noticed under right armpit the lymph nodes were swollen. The pain radiates throughout my chest and shoulder but most severe under the armpit. As of today 22nd I feel tired and I am still experiencing the swollen lymph nodes under my right arm pit. All the other symptoms have went away. The lymph node feels warm to touch, there is also a small area of redness around the injection site. I am still having post COVID-19 symptoms as well which include nasal issues, weakness and brain fog. I have had all these symptoms since November.
65 2021-02-21 migraine Ongoing right shoulder pain and increased migraines
65 2021-02-21 weakness, pain in extremity all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness... Read more
all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
65 2021-02-21 muscle twitching, tingling, muscle spasms, burning sensation sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread th... Read more
sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; she was up all night and couldn't sleep/ restless, had trouble getting sleep, had trouble getting in a comfortable position/ woke up frequently; restless, had trouble getting sleep, had trouble getting in a comfortable position, and woke up frequently.; tightness in her left leg; weird sensations in her legs/ sensations moved to her arms; Ongoing Restasis for Sjogren's syndrome; Ongoing Restasis for Sjogren's syndrome; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: L9261) via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included ongoing Sjogren's syndrome from 2015 (sees her Rheumatologist/ do blood work once a year to make sure her inflammation levels are okay), ongoing rosacea; dry eye syndrome (related to Sjogren's syndrome); spasming, burning and twitching (last 2 medications she was on in November and January she had similar type reactions in her muscles); arthritis flareup from Oct2019 (in her left leg, she saw her neurologist who did tests and they came back normal) and sinus infection in 2020. Ongoing concomitant medication included ciclosporin (RESTASIS) for Sjogren's syndrome, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for blood test: deficient and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) for dry eye syndrome related to Sjogren's syndrome. The patient previously took prednisone from Nov2020 and experienced weirdness in her legs got strong enough to keep her up at night and bad flare up for her leg symptoms; metronidazole for flare up or Rosacea (0.75% as needed, which she has used daily for last few weeks), meloxicam in Nov2020 and pantoprazole in Jan2021 and had bad flare up for her leg symptoms (symptoms subsided as soon as she stopped taking the medication after about 5 days); ibuprofen, acetaminophen and pepcid for her stomach. She had the vaccine, her first dose, on 27Jan2021, about a week ago. The first two days she didn't notice anything and then she had weird sensations in her legs on 28Jan2021. The second night she had a weird sensation in her legs which was similar to what she had experienced with the two medications she took in November and January. On 30Jan2021 the sensations spread through her body, she describes these sensations as twitching, burning, cramping, and tingling. She clarifies the sensations moved to her arms which did not happen with the other medications that she tried in November and January. Monday night, 01Feb2021, she was up all night and couldn't sleep and says she called the family doctor yesterday and he called in a prescription for Gabapentin 100 mg. She said she took the medication last night and she did sleep last night, but she was unsure if it was from exhaustion from the last few nights from not sleeping or the medicine, but she did sleep better and her symptoms were a lot less last night. Patient said she wanted to report this and that her concern is with the second dose; will she have a worse reaction, is there anything she can do or take and should she be concerned about it. She said the events gradually increased, they started mildly and then became significant. She felt the sensations a little bit in the day time but they start big time in the night when laying down. These sensations experienced in her legs started the second night, 28Jan2021, and then spread to her arms in the last couple of days which had not happened with her other incidences (with the medications mentioned above back in November and January). Clarified that the sensations spread to her arms on 29Jan2021, but the worst nights were 31Jan2021 and 01Feb2021. She said they were bad nights. She said in regard to her sleeping, starting on 29Jan2021, she was restless, she had trouble getting sleep and trouble getting in a comfortable position. She woke up frequently. Saturday the sleeping was a little worse, but she did sleep. She said on Sunday, 31Jan2021, and Monday, 01Feb2021, she hardly got any sleep. The sensations spread to her arms and it probably started a little on Saturday night, but Sunday and Monday it was very noticeable. She started Gabapentin; it was one a day before bed. The leg symptoms were still there last night. The sensations in her arms were not much at all. She did get up once with the leg cramp and was feeling tightness in her left leg but it never went into a cramp. The cramp was in her right leg, which was unusual because it was usually in her left leg. She stated she was unsure if her symptoms were starting to subside or if the Gabapentin had an immediate effect. The events did not require a visit to physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.
65 2021-02-21 tingling, feeling hot tongue swollen, throat felt "thick, heaviness in chest, palms of hands felt hot and tingly, started ... Read more
tongue swollen, throat felt "thick, heaviness in chest, palms of hands felt hot and tingly, started as we were leaving the vaccination location outside the hospital about 10 minutes after the shot. No treatment.
65 2021-02-22 feeling hot 78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I ... Read more
78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I felt hot and chilled... I am not sure it was related to the injection. It resolved on sat Feb 20th 2021. I still have mild nausea but am on Ozempic which gives me nausea some of the time. I did not feel well but finally fell asleep and slept until AM.
65 2021-02-22 weakness In the pt's words " received our second covid-19 vaccination on Sunday. I got my vaccination about 1... Read more
In the pt's words " received our second covid-19 vaccination on Sunday. I got my vaccination about 10:00. By 8:00 PM I was not feeling well. Had all of the side effects, chills, fever, muscle aches, joint pain and a wicked headache. Monday was the same minus the headache. Today, still have joint pain and feel very weak. The nurse that gave us our vaccinations said that if we experienced any of the side effects, we should let our primary physician know. Hopefully all of this is normal and I will be back to my normal self soon. I am concerned because most of the information I have read says 24 hours and effects should be gone. Not so with me. Hope all is well with you and your family. " Spoke w/ pt on phone and she stated her s/s are subsiding, other than the arthralgia, RN
65 2021-02-22 bell's palsy Onset of Bell?s palsy 40 minutes after vaccine
65 2021-02-23 migraine, burning sensation About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,... Read more
About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,, and sinuses. States burning feeling is easing yard headache spending to top of head. Client instruct to go home and have husband drive. Plans to take her migrain meds. Says her migraines can start this way too. Left AR 12:13
65 2021-02-23 pain in extremity Almost immediate nausea, light headed, elevated blood pressure, arm pain
65 2021-02-23 weakness I was sick like when you get the flu for two straight weeks. I had absolutely no energy or will to ... Read more
I was sick like when you get the flu for two straight weeks. I had absolutely no energy or will to do anything. Couldn't get out of bed and it felt like my skin was crawling all the time. I have never been so sick in my life. I am NOT getting second shot because NO doctor will help me understand what happened to me. But, you need to know!
65 2021-02-23 feeling hot My cheeks were red and hot.; My cheeks were red and hot.; This is a spontaneous report from a contac... Read more
My cheeks were red and hot.; My cheeks were red and hot.; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9263/expiration date: not provided), via an unspecified route of administration, on 23Jan2021 at 14:30 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included allergic reaction to almonds and brewers yeast in Sep2019, being pre-diabetic, and osteoporosis. The patient had allergies to codeine (all forms), almonds, brewers yeast, mold and dust. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin, alendronate sodium (FOSAMAX), and multivitamin, other supplement. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 at 15:15, the patient experienced that her cheeks were red and hot. The clinical course was as follows: because of a prior significant allergic reaction (Sep2019 determined to be primarily almonds and to a lesser extent brewers yeast), she waited 30 min. and she didn't notice anything until she left the property and removed her mask. Her cheeks were red and hot. She had a diphenhydramine (BENADRYL) tablet (OTC) which within 30+ min reversed it. The outcome of the events cheeks were red and hot was recovered on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
65 2021-02-23 tremor, feeling cold Shaking from being cold. Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwar... Read more
Shaking from being cold. Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwards. Couldn?t eat for / days afterwards. Bad dry cough still persists now 2 weeks later. Took Tylenol nothing helps the dry cough
65 2021-02-24 pain in extremity Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired... Read more
Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired. started about an hour later. Did not sleep well. Stayed in bed the next 2 days. Tightness in chest went away the second day. Third day I felt like myself. These were things that I also experienced with Covid.
65 2021-02-24 feeling hot Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); pos... Read more
Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); possible slight swelling of face and eyes (minor); chills; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 15:15 at a single dose for COVID-19 immunization. Medical history included hypertension and kidney disease, and was allergic to bee stings, penicillin, aluminum chloride. Patient was not pregnant at the of vaccination. There were unspecified medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks prior to. The patient experienced hot red face and neck, possible slight swelling of face and eyes (minor), chills and headache on 29Jan2021 15:30. Outcome of the events was recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
65 2021-02-24 weakness Monday, February 22, in the evening, I started feeling lightheaded, then more debilitating dizzy, ... Read more
Monday, February 22, in the evening, I started feeling lightheaded, then more debilitating dizzy, worsening, nauseas . Went home from work that evening around 9:30 p.m. I Vomited as soon as I got home. Felt better but still lightheaded, dizzy, not as bad. No fever. Couldn't sleep. Tuesday, February 23 felt pretty weak, tired some lingering lightheadedness. Stayed home from work. Next day, Wednesday, my right arm around the injection site was pretty sore. Hard to sleep last night. Took Tylenol for arm. Still somewhat sore today, Thursday.
65 2021-02-24 pain in extremity No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right ... Read more
No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right bodice, up the back of my neck and head on only the right side. I took Tylenol, placed hot packs on the area and drank fluids. I took Advil at 4:00 a.m. Fell asleep and woke up at 8 a.m. I had no temperature but headache was intense. I ate a small breakfast and stayed quiet with hot packs on all areas - 5 p.m. I was feeling much better - went to bed at 7:00 p.m. next morning I was ok.
65 2021-02-24 burning sensation Red, Itchy rash on face & neck, skin hot to touch, burning sensation on face day after shot - also s... Read more
Red, Itchy rash on face & neck, skin hot to touch, burning sensation on face day after shot - also some edema under right eye - small sack of fluid - lasted a few days - took benadryl to relieve itching - dissapated after 4 days but skin was very dry & chapped for about 10 days after
65 2021-02-24 feeling cold She did not have any reactions initially, but noticed the morning after the vaccine that her regular... Read more
She did not have any reactions initially, but noticed the morning after the vaccine that her regular cup of coffee did not taste good. She then had a rash that started on the left side of her neck, went towards the back now. This started a few days after the vaccine, all on the left side. She also got a cold sore on her lip which she had all the time as a child, but not as an adult, which has pretty much resolved. She has been cold, chills and some dizzy spells. She did get a bump on her head concussion in December. One day last week she just stayed on the sofa with a blanket due to feeling poorly. 3 days ago on her back by her shoulder blade an area has been really sore. She did take some Tylenol for the back pain which did not help so she stopped this. She did not call her doctor. The rash is still there but not as intense. It has not itched, but she has felt it.
65 2021-02-24 hot flush Within 15-minutes of vaccination, the patient reported feeling flush, near-syncopal, dizzy, and ligh... Read more
Within 15-minutes of vaccination, the patient reported feeling flush, near-syncopal, dizzy, and lightheaded with diaphoresis. EMS evaluated patient on-site. Patient was hypotensive (89/60). 12-lead EKG showed sinus tachycardia, rate 102 bpm, no ST elevation. EMS transported the patient to Emergency Department for further evaluation. In ED, patient was hypertensive (155/65) with all other vitals WNL. Repeat EKG indicated NSR, low voltage QRS, with no ischemic appearing ST changes. ED physician administered 1L saline bolus and 650mg Acetaminophen. Patient reported feeling better and was discharged with a differential diagnosis of vasovagal episode, electrolyte imbalance, and volume depletion.
65 2021-02-25 pain in extremity 15 minutes after vaccination: stomach queasy and burning in esophagus 12 hours after vaccination: v... Read more
15 minutes after vaccination: stomach queasy and burning in esophagus 12 hours after vaccination: vomiting and diarrhoea and sore arm
65 2021-02-25 difficulty speaking Pt has a history of multiple drug allergies including anaphylaxis. Prior to COVID 19 vaccination we ... Read more
Pt has a history of multiple drug allergies including anaphylaxis. Prior to COVID 19 vaccination we discussed her reaction to previous Pneumovax 12 years prior. Several minutes following administration of the Pneumovax, she developed scratchy throat and hoarseness. Benadryl was administered with improvement in symptoms. She did not require epinephrine or ER visit. We discussed that she had a higher risk of reaction to the COVID 19 vaccine and advised her to wait 30 minutes post injection. During her wait time she began to develop scratchy throat and hoarseness that progressed over 10 minutes. She was taken to the treatment area where vital signs were obtained and 50 mg of oral Benadryl was given. Initial VS were SpO2 of 98, P 82, BP 140/100. She was alert and oriented. No edema lips or tongue. Heart RRR Lungs CTAB with no wheezes. She remained under observation for 30 minutes, vital signs remained stable and BP ranges from 138-140/80-90. She had noticable improvement in her throat and voice and she was discharged in good condition to home under the care of her husband. They were advised that Benadryl could be repeated in 4-6 hours if needed. Should she develop any facial swelling, shortness of breath, wheezing or lightheadedness they should proceed to the emergency department. Reviewed the newly updated CDC guidance on reactions. Although her reaction was immediate it was not considered severe. CDC advised against getting the second vaccine. She is advised to discuss further with her allergist, Dr if she would like to discuss the possibility of getting the second dose with premedication or other precaution. She and her husband understood well and all questions answered.
65 2021-02-25 weakness anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, w... Read more
anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, weakness, unable to take anything by mouth/had lost ability to swallow; swallowing, weakness, unable to take anything by mouth; affected my lungs, gut, muscles, everything.; still having lung issues; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number RM9809), via an unspecified route of administration on 03Feb2021 at the 65 years old at single dose for COVID-19 immunization. The medical history included Muscular dystrophy. The concomitant medications included unspecified multiple medications. The patient received the first dose on 03Feb2021. Immediately after the vaccine on 03Feb2021 she had an anaphylactic reaction, received an Epipen, went to the ER was given steroids and sent home. Next day, still having symptoms, received second Epipen administration, went to Urgent Care, was admitted to hospital 04Feb2021. The patient stated she had a history of muscular dystrophy. She stated she was having issues breathing, swallowing, weakness, unable to take anything by mouth, didn't have normal respiratory support in Feb2021. It had affected her lungs, gut, muscles, everything. She may leave here on hospice. She wanted to know if there were others who had reported side effects such as hers. She had anaphylactic reaction to the mineral. She was still in the hospital. She had lost ability to swallow and she was still having lung issues in Feb2021. She was a disabled rehab healthcare worker. She did not have an address right now in the hospital but if sent her something later once she get out she will be able to do that but she did not have it now. She takes multiple medications. Right now she cannot take medications she need orally. She had gone to hospital getting meds via primarily IV. She had acute anaphylactic reaction immediately after the vaccine and went by ambulance to hospital and was given steroids, care basically and sent home and she still had issues the next day and it kept going from home to urgent care to admission at the hospital. She had done lot of lab tests in Feb2021. She was very concerned that this was not going to be a temporary issue. She had form of muscular dystrophy and now what was happening was the week before she got the vaccine totally independent in her home, feeling ok, medications okay and now she was at IV medications not being able to swallow. She talked to someone yesterday and they told she should be calling and reporting what happened and that was why she had been on the phone all day. She just want make sure she did not feel like the healthcare was reaching out to their own vaccination department and she want to make absolutely sure that not only does Pfizer know that have a horrid reaction but she want the healthcare firm that she had a horrid reaction and she want the CDC to know that she had a horrid reaction because right now she would tell all her friends with the severe form of muscle dystrophy she had not going to be vaccinated even though the researchers were telling her to get vaccinated. It was going to take a while to stop the efficacy again and having to be on the phone everyday when she was barely breathing. The patient underwent lab tests and procedures, which included Lab test unknown result in Feb2021. The outcome of the events was unknown.
65 2021-02-25 weakness one day later, headache and a few instances of vertigo. 3 days later sudden fatigue/weakness/dizzine... Read more
one day later, headache and a few instances of vertigo. 3 days later sudden fatigue/weakness/dizziness in the evening that went into the next day.
65 2021-02-26 flushing Patient had complleted her 30 mintues of observation due to her history of multiples allergies. She... Read more
Patient had complleted her 30 mintues of observation due to her history of multiples allergies. She had left the building and went to her car when she developed facial flushing and was concerned about an allergic reaction so she presented back to the facility for evaluation. Her blood pressure was 152/98 with recheck 190/108. Hr 80s with pulse ox 100% on room air. She has a ast medical history significant for asthma and hypertension. Benadryl 25 mg was given and Paramedics were on site and took over care. She was stable at time of transfer to the hospital.
65 2021-02-27 migraine 103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second da... Read more
103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second day: 101 fever, chills, terrible fatigue and a red rash over entire body.
65 2021-02-28 numbness Bilateral numbness, headache, tongue feels weird, really tired, hx liver transplant
65 2021-02-28 pain in extremity Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe c... Read more
Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.
65 2021-02-28 weakness, pain in extremity Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night w... Read more
Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night with fever, chills, bad headache and body aches head to toe. Took Tylenol. Woke in the morning with fever (101.8), chills, bad headache, body aches head to toe, joint aches and nausea. Took Tylenol. Too sick to get up all of Saturday. Saturday afternoon vomited. Saturday evening fever broke and began feeling a little better. Sunday still had a bad headache, body aches and joint aches. Today, Monday, feeling better but still have a mild headache, body aches and joint aches. I also feel really week and tired.
65 2021-02-28 tremor shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a ... Read more
shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a non-contactable consumer. A 65-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not available/provided to reporter at the time of report completion), via an unknown route of administration on 25Jan2021 at 10:00 AM at a single dose at the age of 65 years old for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included at the age of 64 years, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 25Jan2021 at 22:00, after receiving 2nd dose of COVID-19 vaccine in morning, patient experienced chills, shaking, fever, joint pain, loss of appetite, and headache later that evening. She stayed home from work for 2 days and felt better 48 hours later. The reporter assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, if patient was tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
65 2021-03-01 bell's palsy Bell's Palsy - left facial droop 3 days after administration. Went to primary dr. and got rx for Val... Read more
Bell's Palsy - left facial droop 3 days after administration. Went to primary dr. and got rx for Valtrex and Prednisone.
65 2021-03-01 tingling Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in... Read more
Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in toes and progressed to whole foot), lower leg weakness and fatigue began 16 days post vaccination. Hospitalization 4 days post symptom onset.
65 2021-03-02 numbness, burning sensation About 2 hours after the vaccination, starting low on right side of neck, felt a mild burning sensati... Read more
About 2 hours after the vaccination, starting low on right side of neck, felt a mild burning sensation move up into my right side of face. Swelling on right side was noticeable for two days. Mild numbness also occurred that went away as swelling subsided. However on 3/3/21 I am noticing numbness in upper lip and jaw... also mild.
65 2021-03-02 tingling, numbness Numbness/tingling of right arm
65 2021-03-02 numbness, tingling Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got ... Read more
Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got her 2nd COVID-19 vaccination by Pfizer. She had no ill affects until approximately 10:30 p.m. yesterday (2/23/21) at which time she developed chills her symptoms worsened and by midnight she could not move her arms or her legs and her arms and legs felt numb. She did not have any difficulty breathing. She did not have any numbness in her chest and she did not have any shortness of breath. She did not have any rash and she did not have any swelling or have any headache. She relates that she is better now (2/24/21) although she does still feel like she has weakness of her arms and legs she is now able to walk. The only remaining parenthesia is a little bit of tingling in her right arm. She is still experiencing significant fatigue".
65 2021-03-02 hot flush, feeling hot, pain in extremity She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Hea... Read more
She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Headache; Tiredness; Sleepy like/She had the sleepiness last night; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), on the left arm, intramuscularly, on 30Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. No vaccine administered on the same day as BNT162B2 and no other vaccines administered within 4 weeks prior to administration. On 30Jan2021, it was reported that after the patient got the shot she felt the tiredness, sleepy-like. She had the sleepiness last night, she slept really good. The patient added that she had the first dose and she was fine. Then at night on 31Jan2021 around 1am or 130am her left arm started hurting really bad, it was throbbing. She could not put her hand over her arm, it was so painful. She called her work and was told to put ice on it and take ibuprofen. Patient also experienced headache on 31Jan2021 and took Tylenol which took away the headache, however, the patient reports headache at the time of reporting. Patient reports that on an unspecified date, she is having a hot flash, states she gets warm and then it goes away. The patient did not visit an emergency room but will see her doctor to report what is going on with her. Patient reports she is not going to take the second dose. She took off work Sunday since it was so bad and could not work like that. She is asking what happens if she does not take the second dose and how long does it take for the first dose to wear off. The outcome of the events tiredness and sleepy-like was unknown, for the event headache was not recovered, for the event left arm started hurting really bad, it was throbbing was recovering, while for the events having a hot flash, states she gets warm was recovered. The patient was vaccinated at an assisted living facility for 65+ and not in a military facility. Information regarding batch/lot number has been requested.
65 2021-03-02 pain in extremity experience left arm pain radiating from my shoulder down to my fingers; experience left arm pain rad... Read more
experience left arm pain radiating from my shoulder down to my fingers; experience left arm pain radiating from my shoulder down to my fingers; left arm weakness; This is a spontaneous report from a contactable physician (patient). A 65-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJUe85; expiration date: unknown) at vaccination age of 65-year-old intramuscularly in the left arm on 20Jan2021 10:30 at a single dose for covid-19 immunization. The patient's medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJUe85) at vaccination age of 65-year-old intramuscularly in the left arm on 30Dec2020 at a single dose for covid-19 immunization. The patient received the most recent COVID-19 vaccine in a hospital. On 21Jan2021 after the second Pfizer dose (24 hours after the injection), she began to experience left arm pain radiating from her shoulder down to her fingers. The pain was sharp, constant and associated with left arm weakness. This has persisted for 10 days with no relief and she was still experiencing this pain now. The events were considered as non-serious and did not require treatment. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.
65 2021-03-02 seizure on 2/4/21, patient developed refractory seizures, requiring hospitalization and antiepileptic medica... Read more
on 2/4/21, patient developed refractory seizures, requiring hospitalization and antiepileptic medications among others. She had no history of seizures, as well as negative LP studies and negative CNS imaging.
65 2021-03-02 pain in extremity soreness in my arm; This is a spontaneous report from a contactable consumer (patient). This 65-year... Read more
soreness in my arm; This is a spontaneous report from a contactable consumer (patient). This 65-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) intramuscularly on 08Jan2021 (at the age of 65-years-old) as a single dose in the left arm (deltoid) for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bioidentical hormones, levothyroxine sodium (LEVOTHYROXIN), and liothyronine from unspecified date for unspecified indications. The patient reported an allergy to latex gloves with a reaction of rash. On 08Jan2021, the patient experienced soreness in her arm. The outcome of soreness in her arm was unknown. No follow-up attempts are needed. No further information is expected.
65 2021-03-03 migraine Fever migraine extreme fatigue Migraine headache since this vaccine
65 2021-03-03 feeling hot Later in the evening my throat felt swollen on both sides. I had a warm sensation going through my b... Read more
Later in the evening my throat felt swollen on both sides. I had a warm sensation going through my body. Next evening throat felt swollen on both sides but not as bad as the first evening. Warm sensation could be from vaccine or anxiety. Not for sure.
65 2021-03-03 flushing Pt had a hypersensitivity reaction to her COVID 19 vaccine. Her symptoms included becoming flush and... Read more
Pt had a hypersensitivity reaction to her COVID 19 vaccine. Her symptoms included becoming flush and tachycardic. Her BP was elevated initially (209/117). She did endorse forgetting to take her BP medications this AM and failing to eat anything for breakfast. A medical response was called and the patient received 10 mg of Zyrtec po. An EKG was obtained and read as normal by the responding provider. The patient was observed for a period of 90 minutes until her symptoms resolved and her BP and HR improved. She also had a snack and drink.
65 2021-03-03 flushing itchy all over, flushing. Evaluated by EMS-Cleared
65 2021-03-04 pain in extremity 0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-1... Read more
0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-18.She states no issues with 1st dose on 2/12.0923 Pt report pain and HA has resolved now she feels sleepy. VS as follows 148/86, HR-68, 02 sat 98%, r-20. Pt grandaughter accompanied her here.0937 Pt allowed to go home with grandaughter she reports she feels much better. VS as follows 150/89, HR-77, 02 sat 96%, r-18. Pt instructed to f/u with MD as needed.
65 2021-03-04 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 65-year-old fema... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, expiration date: May2021), via an unspecified route of administration in the left arm on 31Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination was done at a hospital. The patient's medical history included Reynold's syndrome (21 years old at diagnosis), Sjogren's (diagnosed at 30 years old), mixed connective tissue disease (diagnosed around 30 years old), and fibromyalgia (late 40s at diagnosis). There were no concomitant medications. The patient previously received a tetanus shot for immunization on an unspecified date and was allergic to the tetanus shot. This happened when she was 21 years old. The patient also got the new pneumonia shot on 12Jan2021 in her left arm for immunization at the age of 65 years old. The patient got her first dose of BNT162B2 on 31Jan2021. The patient stated she was supposed to get second vaccine 21Feb2021 but that she went to emergency room 13Feb2021 with extreme right eye pain and numbness in lip. She was diagnosed with Bell's palsy. The patient stated that she was not admitted to the hospital, and she just seen in the emergency room. It was reported that it initially worsened, that her eyes were definitely worse until a week later she was scheduled to see her physician and on Wednesday 17Feb2021 she started taking eye drops and now they have not gotten any worse. The doctor said it was not known if it was caused by the vaccine, and stated the patient has certain autoimmune problems Reynaud's, Sjorgen's and mixed connective tissue disorder, all diagnosed prior to vaccine. The patient had no family history relevant to the event. There were no relevant tests. The outcome of the event was not recovered.
65 2021-03-04 numbness, flushing, tingling Face and ears turn bright red. Total body flushing; "pens-and-needles" and then itching. Throat cons... Read more
Face and ears turn bright red. Total body flushing; "pens-and-needles" and then itching. Throat constricted but didn't have a problem with breathing. 8 days later still have "pens-and-needles" in face chest and arms some numbness in my face.
65 2021-03-04 numbness Following day around 8pm started having neck pain then numbness in left arm and face with slight hea... Read more
Following day around 8pm started having neck pain then numbness in left arm and face with slight headache. Lasted two days. Let up a little on third and 4th day. Day 5 almost gone still lingering numbness in left side of face.
65 2021-03-04 numbness Numbless head face arm and headache. Call to Dr
65 2021-03-04 hot flush Patient was administered pfizer covid vaccine at off-site clinic. approx 10 min post injection, she... Read more
Patient was administered pfizer covid vaccine at off-site clinic. approx 10 min post injection, she developed hot flashes, mild sob, and consistent tearing. she did not require any meds on site. Her BP was 222/125. EMS was called. they confirmed BP reading and advised transport. Patient declined transport.
65 2021-03-04 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (patient)¬. A 65-year-old female... Read more
Sore arm; This is a spontaneous report from a contactable consumer (patient)¬. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 11Jan2021 at 12:00 (at the age of 65-years-old) at a single dose for COVID-19 immunisation. Medical history included osteoporosis, stroke history (35-years-old), significant lactose intolerance, gastrointestinal (GI) issues, and allergy to Caine family of drugs. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included evolocumab (REPATHA SURECLICK) and lorazepam (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore arm in 2021. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
65 2021-03-04 feeling cold nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gav... Read more
nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gave her a headache; Feeling cold; chills; muscle pain; joint pain; fever; headache/Headaches was reported as worsened; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (also the age at vaccination) receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at the left arm on 26Jan2021 11:00 AM SINGLE DOSE for covid-19 immunization (reported also as To protect herself). Medical history included that she had a heart cath under anesthesia about two weeks prior to getting the vaccine. She clarifies it was on 30Dec2020. There were no concomitant medications. There was no additional vaccines administered on same date. There was no prior vaccinations (within 4 weeks). No family medical history relevant to AE(s) reported. The patient was vaccinated at a Clinic. The patient previously had a flu shot in Oct2020 and the shingles vaccine in Aug2020 (for immunization). It was reported that the patient had headache, fever, chills, muscle pain, joint pain, nausea and diarrhea after the first dose of the pfizer covid 19 vaccine. The patient wanted to know how long these side effects will last. It was also asked if she should get the second dose of the covid 19 vaccine because she had side effects to the first dose and if the side effects to the second dose or worse than the first dose. It was further reported that the patient got her first shot last Tuesday (26Jan2021). Starting Friday (29Jan2021) she got symptoms. Should she be concerned? She has had tiredness, headaches, (on 27Jan2021) and this morning (01Feb2021) she could not lift her head because her eyes were hurting. When she opening them it gave her a headache. She also had muscle and joint pain (on 29Jan2021) and chills (on 30Jan2021) and fever (on 28Jan2021). She got so cold she covered up with blankets and fell asleep (on 01Feb2021). Then when she woke up it was gone. How long should these side effects last? Should she be concerned? Should she contact her doctor? The reporter also says that most of her symptoms started Friday 29Jan2021. Then she clarifies that actually her symptoms started small before then, on Wednesday 27Jan2021. As the week went on more symptoms came and became other things. It was added that she felt like Friday 19Jan2021 is when she felt the infusion all of a sudden hit her body. That is when she felt the virus hit her with symptoms. Right now her head still hurts. She is not taking as many Tylenol or staying on it regularly like she was. Maybe she should do that again. Could not lift her head because her eyes were hurting. When she opened them it gave her a headache: She says she still has dull pain behind her eyes. She no longer has chills but is feeling cold (on 01Feb2021). Like she chest was frozen on the same side that she got the shot in. They told her to take Tylenol to get relief. But she got concerned as the days went on. She is supposed to get the second dose on 16Feb2021. It was added that it was unknown specific times that these occurred. Friday she would say that she felt it all hit her bad around 11 AM after lunch. The outcome of the event headache, Muscle and joint pain was not recovered; for the event Could not lift her head because her eyes were hurting. When she opened them it gave her a headache and Feeling cold were recovering; for the event nausea, fatigue and diarrhea was unknown; and recovered for the events Chills on 31Jan2021, Fever on 29Jan2021. The AE(s) did not require a visit to Physician office nor ER. Case was considered as non-serious.
65 2021-03-04 tingling started feeling quite itchy at and around the area of the injection site in the upper left arm/It is... Read more
started feeling quite itchy at and around the area of the injection site in the upper left arm/It is a distinct tingly itchy sensation; . It has been pretty much continuous since yesterday and continues today. It is a distinct tingly itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 65-year old female non-pregnant patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: unknown) via unspecified route of administration, on left arm at 11:45, on 23Jan2021, at single dose for COVID-19 immunisation. The patient medical history included heart attack, high blood pressure, high cholesterol. The concomitant medication included carvedilol, rosuvastatin, glycine, glucosamine, colecalciferol (D3) and msm. The patient previously took tylenol and experienced allergies. It was reported that about a week after the injection on 30Jan2021, I started feeling quite itchy at and around the area of the injection site in the upper left arm (as reported). It has been pretty much continuous since yesterday and continues today (as reported). It is a distinct tingly itchy sensation. It was reported that patient didn't see anything unusual in this around the area of the injection site. The patient used cortisone which helped slightly. The patient was not sure if it was safe to take second dose. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was not overweight at all. The outcome of the events was recovering Information on the lot/batch number has been requested
65 2021-03-09 pain in extremity jitteriness; Sore arm; brain fog; loss of some exercise ability; This is a spontaneous report from a... Read more
jitteriness; Sore arm; brain fog; loss of some exercise ability; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 01Feb2021 09:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient medical history was not reported. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication/other medications given within two weeks included 'Metropol.' There was no other vaccine given to the patient within four weeks. On 01Feb2021 12:00, the patient experienced sore arm, first day brain fog and loss of some exercise ability. The patient also experienced jitteriness two days after (03Feb2021). No treatment given for the adverse events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Feb2021. Information about lot/batch number has been requested.
65 2021-03-10 muscle spasms Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fat... Read more
Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fatigue extreme/felt tired; Myalgia; Pain; This is a spontaneous report from a contactable Nurse. A 65-year-old female patient received first dose of BNT162B2 (BNT162B2; Lot number EL0140 for both doses, expiry date not reported) via an unspecified route of administration to right deltoid on 23Dec2020 at 15:00 single dose, and second dose via an unspecified route of administration to right deltoid on 13Jan2021 15:15 at single dose for covid-19 immunization, hepatitis a vaccine (HEPATITIS A) intramuscular on 29Dec2020 at single dose for immunization and varicella zoster vaccine rge (cho) (SHINGRIX) intramuscular from 29Dec2020 at single dose for immunization. Medical history included osteoporosis from 2011, osteoarthritis from an unknown date, Knee replacement (Reported due to the osteoarthritis, she had her one knee replaced in 2004 and her other knee replaced in 2011), Spinal compression fracture in 2011 (Reported she fell at work and had a spinal compression fracture in 2011. She said the spinal compression fracture was repaired by a vertebroplasty in 2011) and Hypothyroidism (she has had hypothyroidism for a long time, since either 1998 or 2000). The patient's concomitant medications were not reported. The patient experienced rhabdomyolysis on 06Feb2021, fatigue extreme/felt tired on 30Dec2020, myalgia on 30Dec2020, pain on 30Dec2020, petechia on 06Feb2021, muscle cramps/muscle spasms on 17Feb2021, dry skin on Feb2021, itching on Feb2021 and her cpk was over 2400 on an unspecified date. The patient was hospitalized for rhabdomyolysis from 06Feb2021 to 09Feb2021 and reported to have caused disability. All the other events were reported as medically significant. She said she wanted to report to Pfizer that she was admitted to the hospital on 06Feb2020. She said she was in rhabdomyolysis, and the rhabdomyolysis was really bad. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she was given a lot of fluids while she was in the hospital. She said her CPK was over 2400 when she was admitted to the hospital on 06Feb2021. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she has a petechia rash, cramps, muscle spasms, dry skin and itching now. Reported she literally saved herself from dialysis by going to the hospital. She said she kept putting off her symptoms, and took Tylenol and Naproxen for the whole month of Jan2021. She said her symptoms started brewing up from day 1, clarifying that her symptoms were not really bad until 30Dec2020 and 31Dec2020. She clarified on 30Dec2020 she took Naproxen, Ibuprofen, and Tylenol for her symptoms, and nothing helped her. She said she knew her symptoms were not normal for her, and she went for the whole month of Jan2021 with her symptoms. She said finally there came a time when she said "oh no, this is not normal at all", and she told herself she needed to check in at the hospital. She said she took Naproxen and Tylenol, and felt a little better, and drove herself to the hospital. Reported she kept walking and taking medicines, and while at work she diverted her mind from her symptoms, but when she came home she felt tired, and would tell herself she couldn't do it anymore. She said she doesn't know if what she experienced was from the COVID-19 Vaccine, but that definitely she had a reaction to either the Hepatitis A booster, the Shingrix Vaccine, or the Pfizer COVID-19 Vaccine. Reported she received 11 bags of Normal Saline (1000ml per bag) while she was in the hospital. She said fluid resuscitation was the only way to bring her CPK levels down and to treat the rhabdomyolysis. Reported her symptoms have improved. She said her last CPK was 134 on Wednesday, 17Feb2021. Reported she had cramps and severe muscle spams in her right leg on 17Feb2021, and then had cramps and muscle spasms in her left leg the following day. She said the cramps and muscle spams have not gone away completely. Reported she has a small petechia rash on her lower legs. She said at the moment the petechia rash shows up on her leg, she knows she is going to have a muscle spasm in that area. She said last night she had 2 petechia rashes show up on the lateral side of her right ankle. She said the petechia rash started to burn, and her right leg calf muscle became heavy. She said she could tell her right leg calf muscle was going to start to spasm, so she took some coconut oil and applied the coconut oil to her right leg calf muscle and massaged her right calf muscle. She said she had 2 areas of petechia last night (23Feb2021). She said the first time the petechia was noticed was when she went to the Emergency Room on 06Feb2021. She said the petechia has been persisting since that time. She said prior to being admitted to the hospital she never had dry skin or itching, but now she has dry skin and itching. She said she was using coconut oil to keep her skin moist. She stated she had 2 telehealth calls (11Feb2021 & 18Feb2021) because of a petechia rash and muscle cramps and was asking her doctor is she may need to go back to the hospital. The patient underwent lab tests and procedures which included blood work, CBC and Thyroid level on 06Jan2021 with unknown results (she had regular blood work done for her yearly checkup on 06Jan2021 (BMP, CBC, and Thyroid level). Also included CPK on 06Feb2021 greater than 2400, CPK on 09Feb2021 566 and CPK on 17Feb2021 134 (units were unspecified), She said her last CPK was 134 on Wednesday, 17Feb2021. Therapeutic measures were taken as a result of rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain, muscle cramps/muscle spasms, her CPK was over 2400. Outcome of the event rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain and her cpk was over 2400 was recovering. Outcome of petechia, muscle cramps/muscle spasms, dry skin and itching was not recovered.; Sender's Comments: Based on the information currently available, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The Hepatitis A booster and the Shingrix Vaccine may have also played a contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-03-12 weakness At 1330 patient started with tongue swelling and general weakness
65 2021-03-14 weakness, tremor Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to ... Read more
Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to Hospital. Was administered IV Benadryl and Prednisone. Slept for three hours. BP dropped to 165 and was released with Benadryl and Prednisone to take for the next four days. Next several days of nausea, diarrhea, fever, weakness, shakes. No energy. Not feeling well until March 14th.
65 2021-03-15 pain in extremity Left arm swelled, pain at injection sight all the way down outside of arm stopping at wrist, then t... Read more
Left arm swelled, pain at injection sight all the way down outside of arm stopping at wrist, then traveling up inside of arm to arm pit. pain subsided but arm is still swollen as of today 03/16/2021.
65 2021-03-15 pain in extremity Patient felt like going to pass out and she did then, she was probably out less than in a minute; Se... Read more
Patient felt like going to pass out and she did then, she was probably out less than in a minute; Severe headache; Nauseous; Throwing up/Vomiting; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient (weight: 81.65 kg, height 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder form an unspecified date. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder. On 22Feb2021, the patient experienced sore arm. On 25Feb2021, the patient developed severe headache, nauseous, and vomiting (throwing up) and the patient felt like going to pass out and she did then, she was probably out less than in a minute. The patient described as following: so, on 25Feb2021, the headache increased throughout the day and her nauseousness continued throughout the day and in the afternoon with the pain of the headache she thought she passed out, she vomited that gave her little bit of relief but then she took "two (not clarified) Advil and went to bed". Clinical outcome of the adverse events was unknown at time of this report. Patient asked if should be expected the same kind of reaction when she got her second shot.
65 2021-03-16 bell's palsy, facial paralysis I was diagnosed with bells palsy in 2005. Full recovery with small amount of paralysis remaining on... Read more
I was diagnosed with bells palsy in 2005. Full recovery with small amount of paralysis remaining on left side of face (left corner upper lip). About 5 days after vaccine noted chewing differently. Eight day after vaccine new paralysis on left side of face now extending to entire jaw area and upper and lower lip. New paralysis on right side of face. Eye won't blink, eye brows won't raise, unable to puff jaw and area next to noise won't move. Twelve days after vaccine minimal improvementlater
65 2021-03-17 inability to speak Just 38.5 hours after receiving my 2nd dose of the Pfizer Covid-19 Vaccine I suffered a Cerebral Vas... Read more
Just 38.5 hours after receiving my 2nd dose of the Pfizer Covid-19 Vaccine I suffered a Cerebral Vascular Accident, a CVA, a Stroke @ 5:05a.m. in our home. My entire right side was paralyzed & unable to speak. My husband alerted #911 & fortunately @ the hosp. I received immediate life saving care. I had a C.T. Scan which revealed #2 blood clots in the left side of my brain. Intravenous T.P.A. was administered & then a thrombectomy was performed. Hospitalized approx. 5:45a.m on Sun., Feb. 28th, 2021 till my discharge on Wed., March 3rd, 2021@ 5:30pm.
65 2021-03-18 seizure, pain in extremity Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing... Read more
Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing issues; Dry heaves; Mucus to come out; Nauseous; Dizzy; Headache; Ears became hypersensitive; Senses heightened; Throwed up; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Feb2021 (lot# EN6205), as 0.3 ml single, for COVID-19 immunisation. Medical history included seizure from 2017 (she hasn't had a seizure in 8 months), allergy (to a lot of things). Concomitant medications were not reported. The patient did not have other vaccinations in 4 weeks prior. Within 15 minutes from having the vaccination at the center the patient experienced the first seizure that lasted about an hour. The seizure was really bad, she had breathing issues, dry heaving like she was trying to throw up, mucus to come out. The paramedics checked her out, they stayed around until she came out of the seizure. The patient went home and then at 07:50 PM she started heavy shallow breathing, was nauseous, dizzy, had a headache, which also happened at the center. Ears became hypersensitive, it was so noisy like loud, but her husband and the paramedics said it wasn't loud but she could hear it, all of her senses were heightened. She had a second seizure and didn't known how long it lasted. Patient had another seizure at 08:25 PM, at 08:40 PM she had another one, at 09:00 PM patient was coming back around and had another seizure and her throat closed up and that's when she went to the hospital, when her throat started to close up. While the patient was in the emergency room (ER) she had another seizure, she had 6 total seizures, she has never had this many before so she knows it was an adverse event to this vaccination. The seizures also increased the patient's heart enzymes- troponin levels. The patient has an EEG, was given 4 baby chewable Aspirin, as she had a mild heart attack. She thought the seizure increased her troponin. The patient mentioned that during the first event at the center, she was so into the seizures, she remembers grabbing her left shoulder, her arm was hurting. She was so into the seizure and trying to throwing up that it didn't dawn on her. The hospital didn't tell her she had a mild heart attack, it just dawned on her because her troponin levels were up mildly and she thought the seizures were triggering something in her heart, not just her seizures. The patient got another headache and was dizzy and had shallowing breathing. Seizures recovered on 28Feb2021. The patient underwent lab tests and procedures which included chest x-ray: normal, it didn't show pneumonia or fluid on the lungs on 27Feb2021, electrocardiogram (EKG): normal on unspecified date, electroencephalogram (EEG): normal on 27Feb2021, troponin: increased on 27Feb2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
65 2021-03-21 pain in extremity delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and nec... Read more
delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
65 2021-03-22 slurring, tingling, migraine Developed paresthesias, migraine headaches, and then was admitted on 3/20, three days after dose #2 ... Read more
Developed paresthesias, migraine headaches, and then was admitted on 3/20, three days after dose #2 with acute dysarthria thought to be due to complex migraine. MRI was negative for stroke. Additionally she had accelerated hypertension. She reports that migraines have not been a problem for 10 years prior. Hypertension has been an ongoing issue.
65 2021-03-22 tenderness Under my right arm(armpit) is very sore, it?s sore to touch with a little swelling, I had the inject... Read more
Under my right arm(armpit) is very sore, it?s sore to touch with a little swelling, I had the injection on Saturday and I woke up this way on Sunday morning
65 2021-03-23 pain in extremity Her arm is sore and swollen; Her arm is sore and swollen; dizziness; rapid heart rate/she started ha... Read more
Her arm is sore and swollen; Her arm is sore and swollen; dizziness; rapid heart rate/she started having a bounding rapid heart beat; SOB/Shortness of breath; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199 and expiration date not provided), via an unspecified route of administration first dose on 07Mar2021 at single dose for Covid-19 immunization. The patient's medical history included allergy history to a of number of medication and things (I'm prone to allergies). The patient's concomitant medications were not reported. On 07Mar2021, the patient received the first dose and she went to sit in the observation area for 5 minutes. The patient was not anxious at all about getting it but she started having a rapid heart rate/ bounding rapid heart beat and SOB/shortness of breath that lasted about a minute. The EMT checked her out and asked her to stay longer and she did and after about 5 more minutes the same thing happened again. These episodes lasted about 1 minute and she had dizziness with it. Also she did not have any further episodes and she stayed a long time. Her concern was whether this was indicative of an allergic reaction and should she still get the second dose. The patient was asking for information about 2nd dose being given after 42 days. The patient stated that she has not had any more of those symptoms at all. The patient arm was sore and swollen that was all now. The events heart rate increased, dyspnea, pain in extremity, and peripheral swelling was assessed by the reporter as serious (medically significant). The outcome of the events heart rate increased, dyspnea, and dizziness was recovered and unknown for the remaining events. Information on Lot/Batch number was available. Additional information has been requested.
65 2021-03-24 difficulty speaking Sinus drainage with cough; Sinus drainage with cough; fatigue; Terrible Laryngitis; post nasal drip;... Read more
Sinus drainage with cough; Sinus drainage with cough; fatigue; Terrible Laryngitis; post nasal drip; minimal raspy voice/Mild hoarseness; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 25Feb2021 13:00 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation . Medical history included diabetes mellitus from 2017 (Diabetes diagnosed 4 years ago) , obesity (Obesity has been 10 years or more) , hypersensitivity (Allergies for lifetime) , arthritis (Arthritis diagnosed 20 some years ago) , hypertension from 2011 (High blood pressure diagnosed 10 years ago) , depression (Depression diagnosed 30 years ago) , breast cancer female from 2019 , breast conserving surgery. Concomitant medication included anastrozole (ANASTROZOLE) taken for breast cancer. The patient experienced terrible laryngitis on 28Feb2021 with outcome of not recovered , fatigue on 01Mar2021 with outcome of recovering , sinus drainage with cough on 04Mar2021 09:00 with outcome of not recovered , post nasal drip on 2021 with outcome of unknown , minimal raspy voice/mild hoarseness. All the reported events were considered Important Medical Events. Course of the events: the patient received the vaccine on 25Feb2021, and 3-4 days after, she started getting terrible Laryngitis. It is a little better. She also was fatigued. She did not run a fever. She did develop a little sinus drainage and cough within the last 4 days. She can smell and taste. She called her doctor and he said it is a side effect or reaction to the COVID vaccine. She wanted to know if that was likely or if there had been reports of any others having this reaction. He told her not to get second vaccine. The patient was difficult to understand due to minimal raspy voice. Follow up information has been requested; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-03-28 weakness Dehydration, hospitalized/dehydrated; My fever broke on Monday; Cruel, incapacitating headache/have ... Read more
Dehydration, hospitalized/dehydrated; My fever broke on Monday; Cruel, incapacitating headache/have such a painful headache that I can't eat; Eye pain; Aversion to food/ can't eat; Constant watery diarrhea despite not much food/diarrhea I have so bad; Constant nausea; Utter and complete lassitude/ exhausted; Being in bed, low energy; Stomach upset; Cough; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female consumer patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 04Mar2021 16:00 as a single dose for COVID-19 immunisation. Medical history included, in the 1990's, was diagnosed with systemic sclerosis (limited, used to be called CREST scleroderma), pretty severe Raynaud's syndrome, telangiectases, fatigue and sometimes joint aches. Patient was healthy despite this. Patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. Concomitant medications in two weeks included amlodipine besylate, escitalopram oxalate (LEXAPRO), and clonazepam (KLONOPIN). The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 11Feb2021 04:00 PM and felt unwell but went to work and was fine in 2 days. On 04Mar2021, it was very different, the patient began having symptoms within 4 hours after receiving vaccine at 9 o clock that night. The patient stated "symptoms worsened and it is one week today and I am still sick. My fever broke on Monday. I still have cruel, incapacitating headache, eye pain, aversion to food (extremely weird for me), constant watery diarrhea despite not much food, constant nausea, utter and complete lassitude, dehydration (hospitalized, 2 liters of fluids), pain meds and anti-nausea meds. I have missed a week of work and this is a serious issue for many. I am OK but using precious sick time." Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient stated "I missed whole week to work and I'm still sick. I have had so many different symptoms and some have gone away like my fever is gone but I have such a painful headache that I can't eat, nausea and constant diarrhea, you get the idea. I'm not against the vaccine but I think it would be good if people like me, people that have had my experience know, I hope it's within the normal range, I still don't know I would love to talk to somebody and find out if what I am experiencing is in the normal range, but it's not, people saying they experience so far the kind of the level of being in bed, low energy, unable to eat, fever, headache, stomach upset, I didn't have a cold, I had respiratory, I had a cough that has cleared up. I was hospitalized yesterday with fluids to become hydrated. It's important for us, you know, I mean, I leave the work that not good, people need to be prepared, it should be sick time I think it's important there is a follow up, absolutely. I was very happy I got the vaccine but I am so sick and it's been a week today so, that's why I decided to call and I was in the hospital yesterday, getting fluids dehydrated and I was admitted (reason for hospitalization was not clarified). I wasn't admitted, I was in the hospital for the day on IV fluids, anti-nausea medication, pain medication also, 3 things they gave me in an IV. They sent me home but the diarrhea I have so bad, I'm exhausted, but I have to spent all my time in the toilet, I thought today might be, I might wake up it would be healing today but I'm still pretty sick." Outcome of fever and cough was recovered, and of remaining events was not recovered. The patient underwent COVID-19 virus test via nasal swab on 03Mar2021 with negative result. Information about lot/batch number has been requested.
65 2021-03-28 tremor, weakness then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feelin... Read more
then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
65 2021-03-29 pain in extremity Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous repor... Read more
Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous report from a contactable 65-year-old female consumer reported for herself. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose (at the age of 65 years old) for covid-19 immunisation. Medical history included osteoarthritis due to car wrecks in younger years, migraine headaches, muscle spasms in back, covid-19 from Jul2020 to an unknown date (still on oxygen from being hospitalized in July with Covid and still get really tired, was home for a week and a half before being transported to hospital for 2 weeks, and received a plasma transfusion). The patient previously took codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, lisinopril and experienced drug hypersensitivity. On 21Feb2021 17:00, the patient experienced headache, tightness in chest, legs hurting from knees down, super tired (felt almost like he did when she had Covid infection and she was still on oxygen from being hospitalized in July with Covid). The outcome of the reported events was recovered. There was no treatment reported. Since the vaccination, the patient had not been tested for COVID-19.
65 2021-03-30 speech disorder, weakness Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in ... Read more
Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in the throat; Headache; Dizzy; couldn't think clearly/her thinking wasn't clear; Confused; sensation in her chest; weak; fatigued; she had a full tongue which effecting her talking; tingling in her lips; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot Number: EN6198; Expiration Date: Jun2021), as single dose in left shoulder on 04Mar2021 at noon for COVID-19 immunisation. Medical history included Hashimoto's disease from May2012 and ongoing (autoimmune condition), ongoing undifferentiated connective tissue disease (UCTD) (autoimmune condition, unsure when diagnosed, started with polymyalgia rheumatica, then it went to rheumatoid arthritis (RA), then it went between Lupus and undifferentiated connective tissue disease), hospitalization: she had to go hospital twice in last 4 months, one was for Amlodipine which has polyethylene glycol and another time for Lisinopril as another blood pressure medication, she had 2 mild anaphylactic reactions in the last 4 months from amlodipine and Lisinopril, patient thought they all have PEG in the ingredients; underwent colonoscopy unknown results. There were no concomitant medications. On 04Mar2021 the patient experienced anaphylactic reaction, gasping for air, headache, dizzy, could not think clearly/her thinking was not clear, tongue swelling, swollen lips, throat closing/restriction in her throat, confused , sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips. Course of events was as follows: The patient drove two hours to get the vaccine. The patient was vaccinated on 04Mar2021 at noon. The reaction started immediately, the caller had a severe headache within seconds, a little bit of sensation in her chest. The patient's thoughts were getting mixed up, she was not thinking clearly. This was one of first things that happened. The patient stumbled a little bit and the nurses were there around her and said she better sit down now. Then the sensation in her throat was starting to feel like it was closing up, her lips were swollen; so she would say she was a little bit confused. The patient started getting dizzy and her thinking was not clear, her tongue swelled, she had a full tongue which effecting her talking, she was gasping for air, she needed a moment to regulate her breathing. In regards to swollen lips she added at first she had a tickle in the throat, tingling in her lips, restriction in her throat, then she started slurring her words before the ambulance got there. On site they responded and watched her because she did not know if the symptoms were going to get worse. The paramedics gave the caller oxygen and an IV, since she had a mild experience she wanted to see what she did not take any medications before taking the vaccine so she could see what it would do, she did not take an ibuprofen or Tylenol. Patient commented, she knew it was not recommended, but some people do it. The patient mentioned started speaking very badly and very fast, she started gulping for air, and was informed the histamines are hitting her. She felt like she was going to faint, she thought if she was able to count back from ten she was going to be knocked out. Once she counted back she started to feel better. Like she would not faint. She did not faint often. She mentioned counting backwards from ten when getting a colonoscopy or something like don't get passed five and then knocked out, so she knows the sensation that can occur. After 1.5 hours they decided to call the emergency number and that was when the ambulance came. The ambulance service was the one who did everything for the patient. Because the patient got in the ambulance, they required her to go to the hospital, she was in a bed in the hall, by the time her doctor had looked at her, her throat had opened up and was feeling reasonably well after an hour an half. Confirmed she was not admitted just in the Emergency Room. On 04Mar202 the patient was at the hospital and was gasping for breath. The patient was on an IV and they gave her 125 mg of Solu-Medrol, 50 mg of Benadryl, and 5 mg of nausea medicine, phedrol the caller thought it was called. They did a good job and that helped the patient down from the most severe symptoms and she wanted to report her symptoms. The patient has been looking around and she thought this reaction it was from the polyethylene glycol. She mentioned historically she had a minor reaction. She had to go hospital twice in last four months. One was for Amlodipine which has polyethylene glycol and another time for Lisinopril which is another blood pressure medication. She confirmed she visited the emergency room for all 3 of these cases. The patient was still very confused on 09Mar2021 and over the weekend, she had to rest, she was weak and fatigued. On 09Mar2021 it was first real day she went back to work. She worked and asked her brother to watch out for her. On 10Mar2021 she was starting to feel a little bit better as regarded anaphylactic reaction, she has recovered with residual effects from the anaphylactic reaction. Confusion was improved but stull a concern. The outcome of anaphylactic reaction was recovered with sequelae, of headache, swollen lips, confused was recovering, of gasping for air, dizzy, could not think clearly/her thinking was not clear, tongue swelling, throat closing/restriction in her throat, sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips was unknown. Patient asked if there was a conclusion about the PEG and her anaphylactic reaction. Her second dose was scheduled on 25Mar2021. Patient stated that her PCP and the CDC recommend to not get the second dose. Caller wanted to know if the anaphylaxis could be worse in the second dose. The patient wanted to know if she should she get the next dose. She was very concerned about COVID as well but did not know if it's worth her risking her life. Patient wanted to know if she can get the Johnson and Johnson vaccine after a certain amount of time after receiving the Pfizer COVID 19 vaccine, caller cannot get the second dose of the Pfizer COVID vaccine due to a reaction. As of 12Mar2021 patent stated she does not wish to be contacted any further. A Product Complaint was filed.
65 2021-03-30 numbness, tingling hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/n... Read more
hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/numbness in her feet up to her knees; little blue squares vibrating and pulsating on her wrists to her finger tips; Severe pain in her right hip; she was ready to pass out; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302) via an unspecified route of administration, administered into the left arm on 06Mar2021 09:45 as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. There were no concomitant medications. On 07Mar2021 at 17:30 patient's stomach had been getting harder all day long, she had severe diarrhea and when she was in the toilet she noticed numbness in her hand, numbness in her feet up to her knees, severe pain in her right hip. She also saw little blue squares vibrating and pulsating on her wrists to her finger tips, she was ready to pass out and thought that she might be having hallucination (AS REPORTED). She was trying to lift her hip off the toilet and just wanted to get to the floor to curl up in the fetal position. Then suddenly all these effects went away and she was fine the rest of the night and has been fine ever since. The patient was asking if these could be side effects of the vaccine or if it was just a part of her IBS. Outcome of events recovered on 07Mar2021.
65 2021-03-31 pain in extremity Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every ni... Read more
Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day; like she had arthritis; Her hair has been falling out/Hair loss; Joint pain; Fingers were frozen; Couldn't eat; barely hydrated; Pain she had in her fingers/ Her toes hurt when she walks; It was hard for her to cook, wash clothes, and do anything; This is a spontaneous report from a contactable Nurse (Patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscular, administered in Deltoid Left on 16Feb2021, 13:15 (Batch/Lot Number: elg267) as SINGLE DOSE for covid-19 immunisation, at 65 years old. Medical history included ongoing Irritable bowel syndrome, she was diagnosed with IBS (irritable bowel syndrome) 15 years ago (unspecified date); Blood pressure high from 2000 and ongoing, High cholesterol from an unknown date (she has had high cholesterol for about 4-5 years or longer), depression from an unknown date (she was diagnosed with depression in her 30s after a car accident. She said she has had post-traumatic stress and depression for years); type 2 diabetes mellitus from an unknown date (she has had Type 2 Diabetes for a while. She said she couldn't take the diabetes medicine. She said she didn't say much to her doctor about the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now); post-traumatic stress from an unknown date. Patient received the first dose of BNT162B2 on 29Jan2021 13:15, 65 years old, (lot number el9262) for covid-19 immunisation and experienced back pain, fatigue, alopecia, malaise, arthralgia, nausea, vomiting, feeling abnormal, musculoskeletal stiffness, arthritis, illness, hypersomnia and fluid intake reduced. There were no concomitant medications. The patient had her second COVID-19 vaccine on 23Feb2021. On 23Feb2021, patient experienced feeling unwell. She has never been so sick; and severe fatigue/fatigue extreme. She got her second COVID-19 Vaccine shot her tiredness was worse. Reported with the regular flu vaccine she had felt bad for maybe 3-4 days, but nothing like how she felt after getting the COVID-19 Vaccine. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. Reported it had been 10-12 days since she had her second COVID-19 Vaccine, and she was still so tired. She is tired all of the time. Her tiredness was worse. She was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad; she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she woke up at 5:30AM today. She said she was exhausted from just going to a doctor's appointment. On 25Feb2021, patient experienced nausea and vomiting. She said she had severe nausea and vomiting, clarifying that the nausea and vomiting lasted 2 weeks. Treatment was Phenergan Syrup 6.25mg/5ml every 6 hours, as needed. She said the Phenergan was originally prescribed for IBS. She said the Phenergan Syrup was dispensed in a pharmacy bottle, and didn't have a NDC, Lot, and Expiration Date. She said the Phenergan prescription label only had a printed barcode. Zofran 4mg tablet, as needed, three times a day. On an unspecified date in Feb2021, the patient experienced her hair has been falling out / Hair loss. She reported that her symptoms while a little better she is still tired all of the time, her hair is still falling out reporting, "If I roll it up in a clump its the size of a golf ball". She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. Hair Loss Treatment: She said the first thing she started taking was 1 Vitafusion Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support. She stated she also took 2 Vitafusion Vitamin C 282mg Gummies a day. She said the product label said to take 3 Vitafusion Vitamin C 282mg Gummies per day, but she only takes 2 Gummies; Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. She said her Fingers were frozen in a half closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to unstick; Couldn't eat and was barely hydrated. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed; Pain she had in her fingers/ Her toes hurt when she walks, she never hand been like this before. She said every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were sore. Treatment: Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6 day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and is to take 1 Prednisone 50mg tablet a day for 6 days; It was hard for her to cook, ash clothes, and do anything. She said she was just laying bed with an ice pack, or a heat pack, and taking pain pills. She said she told her doctor she had called the Health Department, and the CDC. She said the Health Department didn't want to tell her anything, and the CDC will only talk with someone who has had an anaphylactic reaction to the COVID-19 Vaccine. She said she asked her doctor how long she was going to have the side effects. She said her doctor said that all of her patients who had any reaction to the COVID-19 Vaccine, had mostly had called into her office to ask about the COVID-19 Vaccine side effects, and most of the patients COVID-19 Vaccine side effects resolved in a week. She said her doctor said not one of her other patients had ever told her about the kind of side effects she was having. She said her doctor told her she must be in the 2% group and to call Pfizer to report her side effects. She asked how long the events would last and what can she take. The patient underwent lab tests and procedures which included cardiac stress test: all was good right now (unspecified date). Therapeutic measures were taken as a result of her hair has been falling out/hair loss, like she had arthritis, nausea, vomiting, joint pain (arthralgia). Events did not require visit to emergency room. Outcome of the event hair loss was not recovered; outcome of feeling unwell, severe fatigue/exhausted, joint pain was recovering; nausea and vomiting was recovered on an unspecified date; and outcome of all other events was unknown. The patient considered the events as related. The reporter considered the events as serious - medically significant.; Sender's Comments: Based on a temporal association and known drug safety profile, the causal association between the events and the suspect drug BNT162B2 cannot be totally excluded. Possible contribution from patient's underlying medical condition is also considered. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
65 2021-04-04 muscle spasms After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in lef... Read more
After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in left foot was painful and very high anxiety. I started exp cramping in my lower arms I have been to ER, PCP, Ophthalmologist and Neurologist. I'm having terrible headaches as well. The Opthamologist applied eye drops that cause me to go to ER on 4/2 had blood work, checked pressures in eyes, prescribed medications nausea/dizziness, pain in my head and IV for low sodium.
65 2021-04-04 muscle spasms I had muscle spasms, cramping and aching cause lots of anxiety lasting a week intermittent not consi... Read more
I had muscle spasms, cramping and aching cause lots of anxiety lasting a week intermittent not consistent. I went to ER for muscle spasm and heart burn prescribed medication and follow up with my doctor.
65 2021-04-07 muscle spasms Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and musc... Read more
Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and muscles throughout body; aching joints and muscles throughout body; Chills; felt "heavy & on-fire" though cool to the touch (neuropathy); diarrhea; Headache; lower GI distress; muscle cramping all over body; Low-grade fever/temperature 100.9; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included osteoarthritis and upper gastrointestinal (GI) distress. Concomitant medications included omeprazole (PRILOSEC) taken for upper gastrointestinal (GI) distress, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (CAL) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number: EL3249) on 27Jan2021 04:30 PM at left arm. Other vaccine in four weeks reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products reported as no. These symptoms persisted for 24hours: on 18Mar2021 the patient was awoke midnight with chills, severe lower GI distress, diarrhea, head ache, muscle cramping all over body, legs felt heavy and on-fire though cool to the touch; temperature 100.9. Second 24 hours: the patient had low-grade fever, diarrhea, head ache, aching joints and muscles throughout body, continued lower GI distress. After 48 hours: the patient had temperature normal, sore achy body, head ache, fatigue. Consumed only water during first 72 hours then resumed liquids (broth, ginger ale) intake. Effectively treated diarrhea with loperamide hydrochloride (IMMODIUM); dicycloverine hydrochloride (BENTYL) for lower GI distress; resumed omeprazole (PRILOSEC) for upper GI distress. The patient returned to work on 23Mar2021 half-day, 24Mar2021 full-day still not feeling well. On 24Mar2021 during the night, legs were restless from hips down, felt "heavy and on-fire" though cool to the touch (Neuropathy) was similar to first night on 18Mar2021. On 26Mar2021, all symptoms have disappeared and the patient felt good, again she was in very good general health, active, appropriate weight, never ill. Events reported as non-serious. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event fever was recovered on 20Mar2021, of other events was recovered on 26Mar2021.
65 2021-04-07 breast pain, difficulty speaking anaphylactic; reactions are allergic; Terrible airway swelling, it felt like breathing through a str... Read more
anaphylactic; reactions are allergic; Terrible airway swelling, it felt like breathing through a straw, narrowing airway; Sensation of throat closure/narrowing of airway; significant shortness of breath/difficult to breath like through a straw; Pain in both lymph nodes, under both the armpit; Pain in both breasts; Dry cough; Itching, airway/trachea itchy; Hoarseness; Dizziness; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the left deltoid on 15Feb2021 at 15:30 as a single dose for protection against Covid. Medical history included ongoing obesity as she gains and loses it, ongoing hypertension, ongoing asthma (at 59 she was bumped up to moderate degree asthma), ongoing significant food allergies, was born with and had ongoing eczema so she was allergic to milk (was given soy milk since she could not tolerate milk, when she drank milk, it produced phlegm/caused increase in mucus, ongoing significant environmental allergies wherein she would have allergies in the fall, from August through September and would have sneezing, congestion and itchy watery eyes. The patient also had a history of getting bronchitis but has not had it for a long time. The patient got stung by a bee when she was 40ish and her upper thigh got red, itchy and it lasted for 10 days and she and no other symptoms and was now careful around bees. The patient reacts to the smoky matches that blow out and make smoke, from the sulfa in the matches, fireplaces, wood burning and firepits. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, start and stop date were not reported and fluticasone (manufacturer unknown) taken for asthma and allergies, start and stop date were not reported. The patient was on significant medications for her asthma, allergies and blood pressure. The patient previously got a flu shot at the end of Oct2020. The patient also previously took Aleve in her early 40's and was taking them for a neck injury for 2-3 months and at the end of the treatment she broke out in a rash. The patient also previously took aspirin 3 years ago and broke out in a rash. The patient also has an albuterol inhaler but has not taken it for years. The patient was careful, handwashing normally, wipes the shopping carts as they are germy. The patient stated that after receiving the vaccine, one main event was terrible airway swelling, itching and it was difficult to breathe. The terrible airway swelling felt like breathing through a straw and narrowing airway. She stated that it started 18.5 hours after the vaccine, on 16Feb2021 at 10 am and lasted for 4 hours between 10 to 2 pm. The patient also had itching wherein her airway and trachea were itchy which also started on 16Feb2021 at 10 am to 2 pm. The patient experienced narrowing of airway and sensation of throat closure also between 10 am to 2 pm. The patient also experienced that it was difficult to breathe but she did not feel like she needed to go to the hospital. If it got any worse she would gave went to the emergency department. She stated that she was sitting up, walking around and she would have had a significant shortness of breath and she was trying to wait it out. It was difficult to breath like through a straw which also started from 10 am to 2pm. She did not feel like she wanted to walk or do daily activities. She was on the phone with her mother and her mother could hear her difficulty in talking and her heavy breathing. The patient also experienced pain in both lymph nodes, under both armpits and pain in both breasts which started also on 16Feb2021 at 10 am and lasted for 24 hours the 10 am the next day. The patient had dizziness which started about noon and when she woke up the next day it as gone which she considered as medically significant since she is never dizzy and it was not due to her blood pressure and she has been on pills for a long time. The patient had dry cough and hoarseness also on 16Feb2021 from 10 am to 2 pm. The patient was afraid to take the second vaccine and she spoke to her pulmonologist who knows her history and was told that she would benefit. She thought that if she felt bad, she would go to the emergency room if it got worse but it did not. The patient stated that she thinks these reactions are allergic, the itching and narrowing of throat can be anaphylactic. The patient did not require any medical intervention and was not seen in the emergency department and was not hospitalized. The events lasted for 4 hours and stayed at that level. The patient did not get any treatment and it went away. The outcome of the events terrible airway swelling, it felt like breathing through a straw, narrowing airway, Dry cough, Itching, airway/trachea itchy, Hoarseness, Sensation of throat closure/narrowing of airway, reactions are allergic and anaphylactic was recovered on 16Feb2021 at 14:00. The outcome of dizziness was recovered on 17Feb2021 and the outcome of pain in both lymph nodes, under both the armpit and pain in both breasts on 17Feb2021 at 10:00. The patient reported that the events were considered as medically significant. The relatedness of the drug to the reactions from primary source reporter (method of assessment: Global Introspection) for the events was related.; Sender's Comments: A contributory role of vaccine BNT162B2 to reported events cannot be fully excluded since it is part of the product safety profile. Potential contributors include patient's advanced age, as well as underlying obesity, hypertension, asthma, eczema, multiple allergies and other co-morbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
65 2021-04-07 speech disorder she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling... Read more
she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling in throat created an infection; throat feels dry; a lot of congestion in chest and in the lobes; a lot of congestion in chest and in the lobes; Lymph nodes in throat swelled up; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Lot Number: EN6198, NDC number: 59267100001, Expiry date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 65-year-old) at single dose for COVID-19 immunization. Medical history included ongoing asthma diagnosed about 40 years ago in 1981. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for asthma had for a number of years, keeps them on hand; and salbutamol sulfate (VENTOLIN CR) taken for asthma, had for a number of years. The patient got the first shot and she have asthma but forgot to tell them that she has asthma and no one asked her first. The patient got pretty sick on unspecified date and she is trying to figure out if this could be from the vaccine. On 06Mar2021, her lymph nodes in her throat swelled up and her throat was raw, painful, super red and she could hardly talk, it also created a lot of congestion in chest- the lobes. The swelling in throat created an infection on unspecified date. She wound up going to the doctor and they prescribed her an antibiotic which cleared the infection in her throat. Her symptoms started two days after she received the shot. She is supposed to get the second shot on Thursday 25Mar2021 and that's why she is calling to find out information on what other people reported as far as asthma patients. She is debating on getting the second shot. Initially caller states that for the most part, it cleared up and went away about three days ago, but then explains it is gradually getting better. Every once in a while, her throat feels dry and raw, but she drinks water and it feels better. At first, she did not want to really talk. She has asthma, the congestion never really goes away and it didn't really improve this time after prednisone like it usually does. She did not feel good on Friday, but on Saturday it got bad. Her side effects have improved from what they were then. The patient recovered from the event swelling in throat created an infection on unspecified date. The outcome of got pretty sick and throat feels dry was unknown and the outcome of the remaining events was recovering. No follow-up attempts are possible. No further information is expected.
65 2021-04-08 weakness On Apr. 3 I had vertigo and fell on my back in the bedroom. 15 minutes later I started vomiting and ... Read more
On Apr. 3 I had vertigo and fell on my back in the bedroom. 15 minutes later I started vomiting and nausea and then went to the Emergency room. Hospitalized for 5 days. Discharged on Apr. 7 but still very weak and need help getting up or lying down.
65 2021-04-10 one side paralysis, weakness Vaccine given on 3/21/2021 - Chills, headaches , weakness and fatigue started on 3/22/2021- no fever... Read more
Vaccine given on 3/21/2021 - Chills, headaches , weakness and fatigue started on 3/22/2021- no fever. Weakness,chills and fatigue and headaches progressed until 4/01/2021 when patient experienced complete weakness in left arm and leg and unable to stand or walk. Prior to 2nd dose, patient was recovering from a stroke and was beginning to walk with assistance and a cane. After April 1, 2021, patient is unable to stand or walk. Chills, headaches weakness and fatigue continue as of April 11, 2021
65 2021-04-15 pain in extremity About a week after my first shot, the middle joint of my fifth finger on my left had became sore, es... Read more
About a week after my first shot, the middle joint of my fifth finger on my left had became sore, especially upon touch. It also stiffined. About a week after my second shot, the middle joint of my fourth finger became sore, especially upon pressure and is somewhat stiff. I have no history of any type of arthritis nor is it in my family. I had no problems with my fingers on either hand prior to the vaccinations. I play piano and never had any pains nor stiffness.
65 2021-04-18 night sweats High fever, severe night sweats, blood clots in lungs
65 2021-04-20 weakness Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weaknes... Read more
Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weakness, & fatigue that had started 4/4/21 and diagnosed w/COVID-19 (4/10/21). She had just received 2nd vaccine (3/27/21), but had been exposed to COVID-19 the following day from a relative. She was discharged w/dexamethasone and pulse oximeter. Symptoms had continued to worsen and returned to ED where she was admitted for acute hypoxemic respiratory failure and tachycardia secondary to COVID pneumonia requiring steroids, remdesivir, oxygen, but unfortunately succumbed to her illness (4/18/21) given condition critical and prognosis poor.
65 2021-04-23 weakness Left eyelid swollen and purple; Sharp pain on her left eyelid; Very weak and fatigued; Very weak and... Read more
Left eyelid swollen and purple; Sharp pain on her left eyelid; Very weak and fatigued; Very weak and fatigued; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered in Deltoid Right on 28-JAN-2021 16:00 at single dose for COVID-19 immunisation. Patient medical history included COVID-19 Virus and diabetes runs in family, but she just had a physical. Patient did not have diabetes. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29 Jan2021, the patient had experienced very weak and fatigued very weak and fatigued. On 30 Jan 2021, the patient had experienced sharp pain on her left eyelid. On 31 Jan 2021, the patient had experienced left eyelid swollen and purple. Next COVID-19 Vaccine in 18Feb2021. The patient did not received other medications within 2 weeks of vaccination. Patient was not on any prescription or over the counter medications. She took Eye Relief Eye drops and Benadryl for her eyelid swelling. Benadryl and Eye Relief eye drops did not do anything for swollen eyelid. Provided, lab-1451-1.0, on back of fact sheet for recipients and caregivers. On an unspecified date in 2021 the events sharp pain on her left eyelid and very weak and fatigued was resolved. At the time of reporting, the outcome of the event left eyelid swollen and purple was not recovered..
65 2021-04-24 cold sweat blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; ... Read more
blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; clammy and lethargic; clammy and lethargic; respiratory rate was 8; This is a spontaneous report from a contactable nurse (husband). A 65-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EW0153), intramuscular, administered in Arm Right on 08Apr2021 12:30 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at Administration facility. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included diabetes, hypertension, depression, and known allergy to sulfa. The patient was not pregnant. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; and BP (blood pressure) meds, ECT therapy. The reporter stated that he and his wife came around at 12:30 (08Apr2021) and got her first dose of COVID vaccine. They waited in observation for 15 minutes. They went to go eat after the shot and he stopped to get gas and his wife stated "I don't feel right and I am breaking out in a sweat." So, he just came back over here to the vaccine site. When nurse approached the car, the patient in the passenger seat appeared diaphoretic, clammy and lethargic. She was responsive oriented to four spheres and denied pain. She said "I just don't feel right." Pulse rate was 63, respiratory rate was 8, BP was 120/60 O2 saturation 97%. The patient stated "I am a diabetic and blood sugar was 140 this am." She is on insulin and BP meds her spouse stated, Advanced EMT on site checking vitals. Epi 0.3 was given in right thigh per EMT and patient was transported to ER via ambulance. All adverse events started on 08Apr2021 01:15 PM. The adverse events resulted in Emergency room/department or urgent care. The patient received corrective treatment for the reported adverse events. Outcome of the events was recovering. The patient had no COVID prior to administration of bnt162b2 and was not tested for COVID post vaccination.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
65 2021-04-27 weakness April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vacci... Read more
April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vaccine experience with family member and relative. April 23 morning, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced death right after midnight at 12:04 April 25th. Reason of death given is "septic shock secondary to ischemic bowel & intra-abdominal sepsis". But it is the blood clots issue that is causing it. I was told that after my auntie got into hospital the very next day after Pfizer vaccine, hospital later found out that my auntie has blood blockage issue that is causing blood couldn't flow to her intestines. The acid in her blood was very high, 6+. After more than 6 hours without blood to her intestines, her intestines tissues start dying and turned black color. Doctor found out about this at the night of April 23, 2021 nighttime. April 22, 2021 morning is the day my auntie got her Pfizer covid vaccine. There is a very high chances of the Pfizer vaccine is causing the blood clots that lead to blood blockages.
65 2021-04-28 seizure, muscle spasms Spasms in left arm; Went to ER bc I thought it was a seizure; This is a spontaneous report from a co... Read more
Spasms in left arm; Went to ER bc I thought it was a seizure; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 65 years, via an unspecified route of administration, administered in Arm Left on 20Jan2021 (Batch/Lot Number: EL3247) as a single dose for covid-19 immunization. Medical history included cancer from an unknown date and unknown if ongoing. Concomitant medications included levetiracetam (KEPPRA); mesalamine; prednisone; and folic acid, all taken for an unspecified indication, start and stop date were not reported. In Jan2021, the patient experienced spasms in left arm and went to ER because she thought it was a seizure. The patient was hospitalized due to the events for 2 days. The patient underwent lab tests and procedures which included negative test for Covid-19 on 26Mar2021. The outcome of the events was recovered with sequelae
65 2021-04-28 muscle spasms, numbness, seizure Spasms in left arm; ultimately leading to the left arm becoming completely numb after 2nd dose; went... Read more
Spasms in left arm; ultimately leading to the left arm becoming completely numb after 2nd dose; went to emergency room because she thought it was a seizure; shortness of breath ever since 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 14Feb2021 (at the age of 65 years old) (Lot Number: EM9810) as single dose for COVID-19 immunisation. Medical history included cancer. The patient was not pregnant at the time of vaccination, had no known allergies and did not have COVID prior to vaccination. Concomitant medications included levetiracetam (KEPPRA), mesalamine, prednisone and folic acid; all taken for an unspecified indication, start and stop date were not reported. The patient had her first dose of BNT162B2 on 20Jan2021 for COVID-19 immunization and experienced spasms in left arm and seizure. No other vaccines were administered within four weeks. In 2021, patient experienced spasms in left arm, ultimately leading to the left arm becoming completely numb after second dose. Patient went to emergency room because she thought it was a seizure. This happened twice. She also had shortness of breath ever since second dose. The events resulted in hospitalization for two days from an unknown date in 2021. It was unknown if any treatment was given. The patient recovered with lasting effects The patient underwent COVID-19 test (nasal swab) with result of negative on 26Mar2021 (post vaccination). The outcome of the events was recovered with sequel. No follow-up attempts are needed. No further information is expected.
65 2021-04-28 bell's palsy stroke; face sunk in and changed/Bells Palsy; This is a spontaneous report from a Pfizer-sponsored p... Read more
stroke; face sunk in and changed/Bells Palsy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 16Mar2021 at 14:00 as a single dose for COVID-19 immunization. Medical history included a mild case of COVID-19, last year, on an unspecified date in 2020. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks of the COVID vaccine. On 21Mar2021, the patient's face sunk in and changed. The patient's symptoms were not improving. Her eye and right side of her face are affected. She cannot close her right eye. She worked on it and is now able to close right eye not like the left eye closes, but it doesn't blink as the left eye does. She has been using eye drops for this. She said it was Bells Palsy. The patient added that it is hard to look in the mirror. She will not get the second dose. She was not interested in taking the vaccine now. She wanted to wait and see. It being so new and see. Her sister took it and encouraged her, and said it is necessary because they like to travel. She got Prednisone when she was at the hospital, they gave her 60mg Prednisone. Her physician didn't want to keep her on it too long and said it may cause other complications. Her physician cut her off, she weaned her down 50mg, 40mg, 30mg, 20mg, then 10mg. When the patient noticed her face start to turn, she went to the ER. She thought she was having a stroke. The patient was not admitted to the hospital. The outcome of the event face sunk in and changed/bells palsy was not recovered while the outcome of the event stroke was unknown.
66 2020-12-31 hot flush Pain, soreness at injection site, flushed feeling.
66 2021-01-03 burning sensation Patient developed painful hives, blisters, burning, itching
66 2021-01-04 weakness 66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg ... Read more
66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg po, diphenhydramine 50mg PO at 1000. She also was administered NaCL 0.9% as a carrier for durvalumab as an infusion between 1000-1200. Pt was administered COVID19 vaccine at 1110. At 1120 patient called out stating "I just don't feel right". Pt was diaphoretic/weak/hypotensive. No swelling or respiratory distress noted during the episode. Attending physician and PharmD alerted and were at bedside. Per note, pt has needle phobia. Please refer to relevant history below for information regarding BP. Patient was monitored closely at the infusion clinic. She was able to receive her chemo agent as planned after she felt better from eating. Patient does not wish to get the second dose of covid vaccine.
66 2021-01-04 feeling cold, weakness Have been up all night long freezing, shaking; had to take a hot bath just to warm up; Every time I ... Read more
Have been up all night long freezing, shaking; had to take a hot bath just to warm up; Every time I get up, I get light headed; I had COVID back in March and I feel the same way I felt then except the breathing is normal; Very weak; This is a spontaneous report from a contactable consumer reporting for herself. A 66-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation . Medical history included blood pressure measurement on an unknown date. The patient had been up all night long freezing, shaking; had to take a hot bath just to warm up on 24Dec2020 with outcome of unknown , every time she got up, she got light headed on 24Dec2020 with outcome of unknown , she had Covid back in March and she felt the same way except the breathing is normal on 24Dec2020 with outcome of unknown , very weak on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Mar2020. Information about Lot /batch number has been requested.
66 2021-01-04 speech disorder difficulty communicating, difficulty thinking; difficulty communicating, difficulty thinking; diffic... Read more
difficulty communicating, difficulty thinking; difficulty communicating, difficulty thinking; difficulty communicating, difficulty thinking/She could not talk; her tongue was acting like it was swollen; Headache; Dizziness/she got really dizzy; This is a spontaneous report from a contactable consumer (patient). A 66 years old years female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1685, Expiry Date: Mar2021) via intramuscular at right arm on 22Dec2020 16:00 at single dose for preventative (COVID-19 immunization). The patient's medical history was allergic to iodine, yellow jackets, and perfumes or colognes. The concomitant was reported as none. The patient clarified that after receiving the vaccine she started with headache and then she got really dizzy. The dizziness lasted for about a day. Headache lasted for about 2 or 3 days. She had difficulty communicating with people or thinking. She could not talk, her tongue was not swollen but her tongue was acting like it was swollen. Events onset date was in Dec2020. She experiences these symptoms when she has any reaction to her allergies. Treatment included that She has been taking what she always takes for her allergies which is Tylenol for headache and Benadryl for her allergies. Her second dose was scheduled for 12Jan2021. She was asked to go to the hospital but she did not have time to go to the hospital. States she works three jobs and did not have the time. The outcome of the events was recovered completely from all side effects on Christmas day (on 25Dec2020).
66 2021-01-05 pain in extremity SORE ARM
66 2021-01-05 cold sweat Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward aro... Read more
Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward around shoulder blade, severe headaches, nausea (no vomiting), sore throat, FATIGUE, chills/cold sweat, general body aches.
66 2021-01-06 numbness Right sided facial & top lip Numbness & recurring pain; Right sided facial & top lip Numbness & recu... Read more
Right sided facial & top lip Numbness & recurring pain; Right sided facial & top lip Numbness & recurring pain; Right sided facial & top lip Numbness & recurring pain; This is a spontaneous report from a contactable consumer reporting for herself. A 66-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via unspecified route of administration on 29Dec2020 13:30 on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included Hypertension, Reflux and low back pain. Concomitant medications included ibuprofen, dicycloverine hydrochloride (BENTYL), Valsartan and omeprazole. The patient previously took codeine, Bactrim, Zyrtec and experienced allergies. The patient experienced Right sided facial and top lip Numbness, recurring pain on 31Dec2020 16:00. All events resulted in emergency room visit and Hospitalization on 31Dec2020 for 1 day. The patient underwent lab tests and procedures, which included Cat scan, MRI, ultrasound of heart and labs on unspecified dates, Nasal Swab/Covid 19 test on 01Jan2021 with negative result. The outcome of the events were not resolved.
66 2021-01-07 feeling hot Pounding heart rate, it is faster than normal; can hear her heartbeat in her ears; Felt like she had... Read more
Pounding heart rate, it is faster than normal; can hear her heartbeat in her ears; Felt like she had fever and felt like kind of warmish; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0140), via an unspecified route of administration, on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included seasonal allergy, brain aneurysm, psoriasis, diabetic, blood pressure, immunosuppressant, cholesterol, and stent in brain. The patient's concomitant medications included metformin, semaglutide (RYBELSUS), valsartan for blood pressure, acetylsalicylic acid (ASPIRIN), ustekinumab (STELARA) as immunosuppressant for psoriasis, and an unspecified statin for cholesterol. The patient took the COVID vaccine yesterday morning (30Dec2020) at the hospital and she had like a pounding heart rate, it is faster than normal, but it is pounding. The patient can hear her heartbeat in her ears. The patient took her blood pressure and it is normal at 123/78 something like that. Heart rate is an over - little 72, 75, little bit fast but not tachycardia. The patient felt like she had fever and felt like kind of warmish, but her temperature is 98.2. As treatment, the patient took an over-the-counter medication, paracetamol (TYLENOL). The outcome of the events was unknown.
66 2021-01-07 pain in extremity She verbalize she develop pain in left leg and dizziness. She was evaluated onsite by Fire Rescue a... Read more
She verbalize she develop pain in left leg and dizziness. She was evaluated onsite by Fire Rescue and released home feeling better at 9:51 am.
66 2021-01-09 muscle spasms The concern was the gi symptoms,,,severe cramping nausea, vomiting and bloody stool
66 2021-01-10 pain in extremity, weakness 1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 9... Read more
1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 99.3, muscle pain arms and legs worse Uncomfortable during the entire night (tossing and turning) 1/10/21- 07:30-General malaise(flu like symptoms)- muscle pain-feeling weak T-99 started feeling better during the late afternoon, still with muscle pain , T-98.7
66 2021-01-11 feeling hot "45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,... Read more
"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,muscle aches , pain some Syncope, nausea, sweating on and off, oral herpes outbreak just like I did when I had Covid -19 in April"
66 2021-01-11 pain in extremity PATIENT HAD A SORE ARM ON THURSDAY. ON SATURDAY MORNING SHE WOKE UP WITH A SWOLLEN, RASH AREA AROUN... Read more
PATIENT HAD A SORE ARM ON THURSDAY. ON SATURDAY MORNING SHE WOKE UP WITH A SWOLLEN, RASH AREA AROUND THE SITE OF THE INJECTION. ON SUNDAY THE AREA WAS LESS SWOLLEN. ON MONDAY SHE CAME IN TO SHOW ME THE RASH. IT WAS A STRAIGHT HORIZONTAL LINE WITH RED PETECHIAE AROUND THE LINE, EXTENDING TO THE REAR ARM PIT AREA.
66 2021-01-11 numbness The 'left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minut... Read more
The 'left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away'; she felt 'a wave of nausea; This is a spontaneous report from a contactable consumer for herself. This 66-year-old female patient received the first dose of BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient stated 3 hours after having received the vaccine, she felt 'a wave of nausea that went away just as fast as it had hit' her. The left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away. This was on the same side that she got the vaccine. She had never experienced anything like that. The outcome of event face went numb was recovered. The outcome of other events was unknown. Information about Batch/Lot number has been requested.
66 2021-01-11 flushing Vaccine administered at 08:17am. At 9:10, patient felt flushed and dizzy and experience tingling in ... Read more
Vaccine administered at 08:17am. At 9:10, patient felt flushed and dizzy and experience tingling in mouth; patient was administered Benedryl orally at 9:20am. At 9:25, 911 was called and an Epi was administered that was available provided by on-site pharmacist. Patient was subsequently transported by local EMS to a healthcare facility.
66 2021-01-12 pain in extremity Headache, generalized body aches/pain, pain in legs for 18 hours
66 2021-01-13 pain in extremity Aching in arms & legs; After 2nd vaccine felt like I had the flu; This is a spontaneous report from ... Read more
Aching in arms & legs; After 2nd vaccine felt like I had the flu; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 15Dec2020 15:00 (lot EH9899, expiry date not reported) in the left arm, then second dose on 05Jan2021 (lot EL0142, expiry date not reported); both via an unspecified route of administration at a single dose as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had other medications (unspecified) in the two weeks prior to vaccination. The patient was not pregnant at the time of vaccination. On 06Jan2021 02:00, the patient experienced aching in arms and legs, and reported that after 2nd vaccine felt like patient had the flu. The patient did not receive any treatments for the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient recovered from the events aching in arms and legs and felt like patient had the flu in Jan2021.
66 2021-01-13 night sweats Day following: severe body aches, chills and fever and slight nausea. The second day following inje... Read more
Day following: severe body aches, chills and fever and slight nausea. The second day following injection felt a bit better but that evening night sweats and third day following quite nauseated.
66 2021-01-13 tremor chills, shaking, headache, neck ache, joint pain, nausea, vomiting
66 2021-01-14 breast pain Hardly can walk body aches right breast hurts
66 2021-01-14 pain in extremity, pain in extremity Sore arm, headache
66 2021-01-14 pain in extremity Sore arm, loss of appetite, fatigue, extreme dizziness, drop in blood pressure
66 2021-01-15 muscle spasms about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomac... Read more
about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomach and intestine cramps and 3 days later i still have them. also still have lots of nausea. body aches all over. swelling ankles more on right side, headache, fell sick all over. no treatment just staying in bed.
66 2021-01-17 numbness, muscle spasms 1/15/2021 11:00 p.m. developed orbital edema took Benadryl 75 mg PO. 1/16/2021 morning orbital edema... Read more
1/15/2021 11:00 p.m. developed orbital edema took Benadryl 75 mg PO. 1/16/2021 morning orbital edema improved but still present, shortness of breath, lips tingling, swollen tongue, facial numbness around mouth and cheeks. Benadryl 50 mg every 4-6 hours, Prednisone 10 mg, Tagement 1 pill (unknown dose), Afternoon developed GI symptoms cramping diarrhea took Bentil 20 mg 1/17/2021 Continued facial swelling Benadryl 50 mg 1/18/2021 Symptom resolution
66 2021-01-17 burning sensation Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea... Read more
Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea, impending doom feeling that something was really wrong, foggy brain Benadryl 50mgm, Epinephrine, Observation,
66 2021-01-17 pain in extremity On 1/16/2021 , 4 hours after I had my Covid-19 injection my left arm started to hurt and was started... Read more
On 1/16/2021 , 4 hours after I had my Covid-19 injection my left arm started to hurt and was started to get real hard in the muscle. I took 2 naproxen and 2 tizandine. I could not use my left arm from 4:00 pm-10:00 pm. On 1/17/2021, I woke up and my left arm was real hard and I could not use my arm all day and night. I took 2 naproxen, 2 tizandine and 1/2 tramadol. On 1/18/2021, I woke up and my left arm is back to normal.
66 2021-01-18 tingling Patient had slight swelling in her hand and tingling at the injection arm. Patient took two Benadryl... Read more
Patient had slight swelling in her hand and tingling at the injection arm. Patient took two Benadryl 25 mg capsules and the swelling subsided. 15 minutes later, patient had swelling in both legs. An ambulance was called and patient was taken to urgent care to get treated. Patient was released from urgent care the same day and has recovered.
66 2021-01-20 migraine Cough began 12/27/20 followed by severe migraine on 12/31/20.
66 2021-01-20 flushing, feeling hot Patient reports facial flushing and warmth, lasting about 1-2 hours.
66 2021-01-21 flushing, tingling, numbness At about 4:15 pm which is 3.5 hours after receiving vaccine, I experienced tightness, swelling in my... Read more
At about 4:15 pm which is 3.5 hours after receiving vaccine, I experienced tightness, swelling in my throat, tingling, numbness of my face in around my mouth, red flushing of the skin in my upper chest and throat. I took 2 Benedryl tablets and experienced symptoms for the next hour. They subsided by 5:30 pm . I was able to breathe and swallow during the whole episode. I had very similar reactions several times in June when I was for unknown reasons experiencing hives and had same response when prescribed Bactrim, and then Keflex because of a UTI. I had no further incidents with the chest, throat, mouth reaction since mid June until yesterday. I had no adverse reaction to the vaccine until 3.5 hrs after receiving it. I feel this is because my body has some sensitivity, not that anything was done incorrectly in administration of the vaccine. All personnel were very attentive and careful that I observed.
66 2021-01-21 pain in extremity At the time of the injection was painful, hurt from that point forward and kept on hurting all day. ... Read more
At the time of the injection was painful, hurt from that point forward and kept on hurting all day. Yesterday started hurting in the shoulder and arm continued, still hurts today 1/22/21. Warm to touch, still warm to touch today, knot underneath armpit.
66 2021-01-21 seizure Patient recieved dose of pfizer COVID-19 vaccine and at some point during the week after had a seizu... Read more
Patient recieved dose of pfizer COVID-19 vaccine and at some point during the week after had a seizure that lasted 10 seconds. Patient is being monitored.
66 2021-01-21 weakness Severe weakness Extreme fatigue Loss of appetite
66 2021-01-22 pain in extremity Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm p... Read more
Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm pain, generalized muscle aches. 36 hours after developed chills, fever 102.5, headache, fatigue 48 hours fatigue, muscle aches present but less fatigue lasted 5 days
66 2021-01-22 burning sensation burning and itching on neck, began less than 1 day of COVID vaccination
66 2021-01-23 pain in extremity Severe pain from shoulder down entire arm to fingers and palm of hand. Lasted for about 32 hours. I... Read more
Severe pain from shoulder down entire arm to fingers and palm of hand. Lasted for about 32 hours. I felt like my rift arm was paralyzed. I had to sleep with heating pad for relief. Tylenol for pain.
66 2021-01-23 burning sensation Shingles developed at 14 days after vaccine..I have never received shingles vaccine...burning sensat... Read more
Shingles developed at 14 days after vaccine..I have never received shingles vaccine...burning sensation on 1/20/2021 follow by rash in next 24hrs. Confirmed by Doctor on 1/22. Started Valtrex 1/22.
66 2021-01-24 feeling hot, tingling, flushing A 66 YEAR OLD FEMALE RECEIVED FIRST DOSE OF PFIZER COVID-19 VACCINE ON 01/23/21 AND EXPERIENCED WHAT... Read more
A 66 YEAR OLD FEMALE RECEIVED FIRST DOSE OF PFIZER COVID-19 VACCINE ON 01/23/21 AND EXPERIENCED WHAT SHE THOUGHT TO BE A REACTION TO THE VACCINE. THESE REACTIONS HAPPENED 3 MINUTES AFTER RECEIVING THE VACCINE. SHE REPORTED FEELING HOT, HAD TINGLING SENSATION AND WAS FLUSHING. REPORTED SHE HAD RED EARS, FACE, AND NECK AND FELT THE FLUSH ALL OVER HER BODY. PATIENT REPORTED THAT SHE TOOK BENADRYL 25 MG PRIOR TO RECEIVING THE VACCINE. SHE ALSO REPORTED THAT SHE TOOK ANOTHER BENADRYL 25 MG WHEN SYMPTOMS SHOWED UP. EMS PERSONNEL OFFERED TO TRANSFER HER TO THE ER BUT SHE STATED SHE REFUSED THIS AND SHE SIGNED AN AMA FORM. PATIENT ALSO REPORTED THAT THE SIGNS AND SYMPTOMS DIDN'T PROGRESS AND SHE BELIEVED THIS WAS DUE TO THE EFFECT OF BENADRY. PATIENT REPORTED THAT SHE STAYED ON THE VACCINATION SITE UNDER OBSERVATION FOR 45 MINUTES AND BY THE TIME SHE LEFT THE SITE, THE SIGNS AND SYMPTOMS WERE GONE. PATIENT STATED SHE WILL CONTACT HER NEW PCP FOR FURTHER ADVISE WHETHER OR NOT SHE CAN GET THE SECOND PFIZER VACCINE. PATIENT DENIES ANY PROBLEM TODAY 01/25/21. WILL CONTINUE TO MONITOR.
66 2021-01-25 tremor Fever, body ache, HA, nausea, chills, tremors, O2 sat = 96%
66 2021-01-25 pain in extremity I had soreness in my arm for two days. I had onset on pain on the 28th, it was sudden and serve. I w... Read more
I had soreness in my arm for two days. I had onset on pain on the 28th, it was sudden and serve. I went to ER, nausea, vomiting's, diarrhea. They ran a bunch on test and everything came back negative. I had serve abdominal pain, I didn't have any treatment. On 1/2/21 I started antibiotics and was on them until 1/24/21. I'm still not sure if the pain had anything to do with the Covid vaccine.
66 2021-01-25 pain in extremity Left arm was sore just a little bit; This is a spontaneous report from a contactable consumer (patie... Read more
Left arm was sore just a little bit; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL3246, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 15:15 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient took no other medications in two weeks. The patient experienced that left arm was sore just a little bit on 09Jan2021 . No treatment was received for the adverse events. Clinical outcome of the event was unknown.
66 2021-01-25 flushing Patient with known allergies in observation area following injection noted flushed cheeks, chest tig... Read more
Patient with known allergies in observation area following injection noted flushed cheeks, chest tightness, and reported to clinical manager.(10:16) Given 25mg PO Benadryl and continued observation. AT 10:30, no resolution of symptoms-telehealth visit initiated. Vital signs stable, Oxygen sat at 97%, patient with c/o cough and scratchy throat. Order given and medication administered. Solumedrol 125mg IM. Additional 1 hour observation-symptoms resolved, and patient was discharged to home.
66 2021-01-25 unresponsive to stimuli RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHI... Read more
RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHIBITED ANY SYMPTOMS. RESIDENT WAS OBSERVED TO BE UNRESPONSIVE WITH NO PRESENCE OF VITAL SIGNS ON 1/24/2021. RESIDENT WAS A FULL CODE, CPR INITIATED UNSUCESSFULLY. BASED ON REVIEW WITH PRIMARY CARE PHYSICIAN AND MEDICAL DIRECTOR, THE RESIDENT HAD NOT HAVE ANY OTHER EVENTS PRIOR TO RECEIVING THE COVID VACCINE 4 DAYS PRIOR TO EVENT.
66 2021-01-25 pain in extremity arm soreness; very achy; Drowsiness; bad headache; This is a spontaneous report from a contactable c... Read more
arm soreness; very achy; Drowsiness; bad headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 11Jan2021 at single dose (1.8 cc but unsure ((heard that but could be wrong) recommended dose)) as works with COVID positive patients. Medical history was none. No concomitant medications. Caller just wanted to know if she could take Tylenol for mild symptoms after having the COVID 19 vaccine. She received the vaccine yesterday. She was wondering if it would make the symptoms a little less. She didn't have a prescribing doctor. The side effects started last night. On 11Jan2021, she was expecting arm soreness, but this was worse. She developed it about 6 hours after the shot. This was the sorest her arm has ever been from any injection, and she had had a lot of them. Her arm was almost too sore to move. This morning, it was much better. It was really bad last night. She was also very achy, and experienced drowsiness, also has a very bad headache on 11Jan2021. The CDC website stated before the vaccine patients should not take Tylenol because it can tamper with the immune system response. It said it was alright to take after, but she just wanted to call to make sure. Investigation Assessment was no. The outcome of the event very achy was not recovered, of the events was recovering.
66 2021-01-26 feeling hot PATIENT REPORTED IMMEDIATE TOE TO NECK "IVP DYE TYPE WAVE OF WARM" RESOLVED IN FIRST 5 MINUTES OF OB... Read more
PATIENT REPORTED IMMEDIATE TOE TO NECK "IVP DYE TYPE WAVE OF WARM" RESOLVED IN FIRST 5 MINUTES OF OBS. HYDRATE FULLY RESOLVED AT DISCHARGE.
66 2021-01-26 pain in extremity, tremor Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A hea... Read more
Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A headache; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EH9899, expiry date: unknown), via an unspecified route of administration on 06Jan2021 10:30 at single dose (Right upper arm) for COVID-19 immunization. Medical history included Blood pressure (takes blood pressure medication). The patient's concomitant medications included blood pressure medication. The patient experienced a sore arm, chills, tremor in fingers and a headache when she came home from being vaccinated. The morning after, she experienced dizziness, tiredness and passed out. She then checked her blood pressure and it was fine and then she went to bed and slept all day. She got up around 7 pm and was fine. It was further reports that the patient received first COVID Vaccine on 06Jan2021. She came home and was fine. Arm was a little sore. During night had chills and noticed fingers had tremors. Had a bad headache. Woke up in morning and went to do usual things. Was dizzy and passed out. Woke up on floor. Husband helped her back into bed and she slept the whole day. After that she was absolutely fine. They were curious, but a little bit concerned about taking the second dose. Advised patient to follow up with primary care physician. She went to primary care physician yesterday. Primary care physician advised her to take the second dose of COVID Vaccine stating he didn't see why she couldn't take it. HCP Details: Address and email address are unknown Received first dose of COVID Vaccine on 06Jan2021 around 10:30. Chills: began at 23:00 Fingers had tremors: began 23:00 Bad headache: did not provide time of onset Dizzy and passed out: 08:00 Woke up absolutely fine on 07Jan2021 around 19:00 Indication: 66 years old and it was available to her Causality: Yes, because she was fine before then History and Investigations: Takes blood pressure medication, but blood pressure has been normal. Product name not provided by caller. Vaccination facility type was at a skilled nursing facility. The outcome of the events was unknown. Chills, Tremor in fingers, headache, Dizziness, and Passed out were reported as Medically significant events. Reaction assessed for Chills, Fingers had tremors, Had a bad headache, Dizzy, and Passed out. Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including chills, tremor in fingers, headache, dizziness, and passed out, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
66 2021-01-27 numbness I received the COVID vaccine 1 at 2 PM. At 5:40 PM, the left side of my face was numb. I emailed m... Read more
I received the COVID vaccine 1 at 2 PM. At 5:40 PM, the left side of my face was numb. I emailed my PCP as to what I should do. She told me to go to Urgent Care as soon as I left work, which I did. Because I had Bell's Palsy two years ago at this time, I panicked. I was told by the Urgent Care doctor that numbness is a common side effect (which I had not previously read like I did Bell's Palsy) and the numbness would subside in about a week. She told me to complete this report.
66 2021-01-27 pain in extremity Joint pain; Has a little bit of pain in her finger on the left hand; This is a spontaneous report re... Read more
Joint pain; Has a little bit of pain in her finger on the left hand; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 04Jan2021 15:45, at single dose, for COVID-19 immunization, in her workplace. Medical history included ongoing arthritis (has been cold there) and Crohn's disease so the patient has a tendency to have inflammation. Concomitant medication included vedolizumab (ENTYVIO). The patient experienced joint pain and had a little bit of pain in her finger on the left hand on an unspecified date in Jan2021. Treatment included Salonpas and Tylenol. The outcome of joint pain was recovering (reported as ongoing but a little better); and "has a little bit of pain in her finger on the left hand" was unknown. Information on the batch/lot number has been requested.
66 2021-01-28 difficulty speaking 24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-remi... Read more
24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-reminded if She gets worse-GO the ER-or have someone drive her there-for instance-SOB 25th Jan 2021-Monday-legs, to mid calves-swollen 26th Jan Tuesday-still coughing a lot 27th Jan like the 24th of Jan 2021-hurts to breathe, HA, body slows, hoarse when speaking, Cough a lot. 28th Jan 2021-Thursday-her Back hurt. Her waist & shoulder blades painful 29th Jan 2021-today-she said COVID-19 reaction-that's why she called
66 2021-01-29 feeling cold 24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild chills. While... Read more
24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild chills. While trying to get blankets, turning up heat, preparing dinner, had abnormal muscle and joint pain upon any movement. No muscle or joint pain while sitting still.. 6 hours after symptoms took acetaminophen 500mg and diphenhydramine 25mg . 9 hrs after onset of symptoms felt fine with no symptoms and slept through the night fine. 48 hrs after vaccine feel completely normal.
66 2021-01-29 weakness Extreme fatigue, unable to stand or walk, dizziness, physical weakness, upset stomach,
66 2021-01-29 numbness, tingling Numbness,tingling sensation-I left-side-of-face.??Started-35-hours-after-injection. Lasted3-4hours.-... Read more
Numbness,tingling sensation-I left-side-of-face.??Started-35-hours-after-injection. Lasted3-4hours.-no-other-neurological-symptoms- Took-aspirin-as-symptoms-subsided.
66 2021-01-29 pain in extremity The night of the shot I got very little sleep due to my entire right arm which took the shot aching ... Read more
The night of the shot I got very little sleep due to my entire right arm which took the shot aching and hurting all night til I got up the next morning. Have had not other symptoms but it did scare me that night. My husband experienced soreness of the arm and fatigue.
66 2021-01-31 tingling, numbness Facial muscle tingling which quickly turned to numbness occurred at 5 Pm 1/29/21 Tingling started i... Read more
Facial muscle tingling which quickly turned to numbness occurred at 5 Pm 1/29/21 Tingling started in lips and then moved up the left side of face to forehead and including part of left ear. Numbness followed Symptoms lasted about 3 hours.
66 2021-01-31 feeling hot, tingling Pt. Reports ?warm tingle? in chest, back of neck, L arm. V/S 120/80-BP, 88-HR, 98%-O2, 20-resp. Pt. ... Read more
Pt. Reports ?warm tingle? in chest, back of neck, L arm. V/S 120/80-BP, 88-HR, 98%-O2, 20-resp. Pt. Reports to ?feeling a little anxious? about receiving vaccine. At 10 minutes pt. Reports wariness/tingle was gone. ~20 minutes pt. Reports feeling is now back in opposite are and again in next. V/S 125/80-BP, 85-HR, 98%-O2, 18-resp. ~25 minutes pt. Reports symptoms are again gone. Pt. Education if symptoms return/worsen to seek medical attention. Pt. Expressed understanding.
66 2021-01-31 muscle twitching, numbness Second vaccine Lot Number - EL3248 . 1/19/2021. Twitches in the left calf on the back. Then went t... Read more
Second vaccine Lot Number - EL3248 . 1/19/2021. Twitches in the left calf on the back. Then went to the upper leg. Short pains then they would come and go. Then the pain went to the right leg. Numbness under the left knee. Feel like her calf is full. Going to see a neurologist.
66 2021-01-31 pain in extremity itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an ... Read more
itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; arm soreness; dry throat; arm discomfort; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 17Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included Cholesterol and Blood pressure, patient stated she took low dose medication for her blood cholesterol and blood pressure, but has had no new medications. She had a history of some allergies: a slight shrimp and scallops allergy, possible peanuts, penicillin, and a Neomycin product. She said they were not a big deal, and she had environmental allergies as well. She had an allergic reaction to the eye drop Neomycin, possibly, just the eye drop, she had a little breakout around her lips but she didn't know if it was the drug or not. The allergy to shrimp and scallops showed up in a blood test, her reaction to peanuts around her mouth but she had a negative scratch test and blood test for allergy to peanuts. The patient's concomitant medications were not reported. The patient stated she did get the flu vaccine, that was ok, she was fine, this was probably around Nov2020 or so, though she didn't know off hand when she got it, it was the regular flu vaccine and not an increased dose. The patient experienced arm discomfort on 17Jan2021, itching to eyes, mouth, and throat an hour after vaccination on 17Jan2021 12:00. The patient took the first shot yesterday (17Jan2021) and she had some discomfort to her arm, but it didn't bother her. She got the shot about 11:00 yesterday (17Jan2021) and about an hour after the shot she had some itching to her eyes, mouth, and throat that was not severe then was on and off through the day. She would like to know if this is common, she would like the information for the second dose, if she should expect more or less or same, she was concerned about the second dose. She did not have a severe reaction, she just wanted to make sure there weren't any adverse reaction for that make sure she known. She had not seen a doctor for her itching eyes, mouth, and throat. She didn't do any treatment for it, it was better today (18Jan2021), she just noticed it an hour after the injection that she felt a bit of eyes being itchy and all over, her mouth and throat were not severe, but she definitely felt it through the day. She felt it a little at night sometimes anyway like a dry throat. It was gone this morning and her arm was better, it seemed like the itching went with the arm things since following her arm soreness her itchiness started, then when her arm felt better the itchy was going away. The outcome of events was recovering. Information on the Lot/Batch number has been requested.
66 2021-02-01 pain in extremity, breast pain pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched ne... Read more
pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched nerve in my neck and blood pressure went up to 182/98; arm where she got the shot hurt like it was very tender; left breat hurt/then right breast hurt; having a little bit of trouble with asthma; congested and sneezing; congested and sneezing; bumpy rash on her chest and arms; puffiness/swelling in the neck; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration on 14Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing asthma and high blood pressure unknown if ongoing; both from unknown dates. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for asthma, unspecified vitamins and an inhaler for asthma. On 14Jan2021, the patient received the vaccination. She had a reaction to the vaccine almost immediately within 15 minutes of receiving vaccine. First, she had a pinched nerve in her neck and blood pressure went up to 182/98. Then about an hour later, the arm where she got the shot hurt like it was very tender. Then, her left breast hurt, followed by her right breast hurt. A few days later on 17Jan2021, she had breast pain and also pain under her arm. In Jan2021, she was also have some trouble with her asthma, was congested and sneezing. She had bumpy rash on her chest and arms. It was like tiny little bumps but it was not painful. She also had puffiness/swelling in the neck. The clinical outcomes of the pinched nerve in her neck, blood pressure went up to 182/98, arm where she got the shot was tender, breast pain, pain under arm, trouble with her asthma, congested and sneezing, bumpy rash, and puffiness/swelling in the neck were unknown.
66 2021-02-01 pain in extremity soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going... Read more
soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going to take my late night showers I looked at it and it had blister on it; blister; didn't sleep well/Didn't sleep well; sore arm; Around the skin it is discolored; This is a spontaneous report from a contactable consumer A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 08:15 at a single dose for COVID-19 immunization. Medical history included covid-19 around 15Jun or 16Jun2020 and did the quarantine. The patient's concomitant medications were not reported. Patient had soreness and tiredness the next day after vaccination on 16Jan2021 and took TYLENOL every 4 hours. She was concerned because on 16Jan2021, when she was going to take shower, it looked bruised, and blister on it. Patient didn't know what to do. Patient applied ice packs. The patient had patches, blister on top of that and it was not at the injection site. It's where she applied the ice. That was on 15Jan2021. She also didn't sleep well on 15Jan2021. She took ibuprofen but was not running a fever with no itching. Around the skin it was discolored on Jan2021. Patient was scheduled to get the 2nd dose in 3 weeks. Patient took her Pfizer Vaccine (Covid Vaccine) on Friday morning the 15th approximately 8:15 in the morning. Other than a sore arm on Friday she was okay. They told her to put ice pack on it for soreness. So she did that afternoon. On 16Jan2021, she looked at it in the morning It looked like bruise on the arm, not where she gave patient the injection but down a little below her arm and it looked like a bruise and then in the afternoon she was going to take my late night showers I looked at it and it had blister on it. She took Ibuprofen. She didn't have fever. She felt herself today. On 16Jan2021, in the morning she did feel tired and she did take afternoon nap for about 2-3 hours because before that she didn't sleep well. She already knew that she need at least 8 hours. Patient height was reported as about 5'3.Outcome of the event soreness was not recovered while for the remaining events was unknown. The reporter considered the events as non-serious. Information on lot number/batch number was requested. Follow-up (17Jan2021): New information received from a contactable consumer included: new event (sore arm), patient weight, and event details.
66 2021-02-03 numbness, tingling Approximately 6 hours after injection, I began feeling very tired. I was up walking around office w... Read more
Approximately 6 hours after injection, I began feeling very tired. I was up walking around office working on some computer updates and then cam back to my office. About 15 minutes later while sitting at my desk my hand and feet began tingling, then about 10 minutes later my feet became numb, from toes to ankle, both ankles began to swell and had +Edema, and blood pressure was 123/50 , pulse low and undetected on my electronic BP cuff, taken by wrist it was 42, event lasted about 30 minutes, I forces fluids, took a Benedryl, and walked in my office when numbness subsided.
66 2021-02-03 pain in extremity Awaken at night with very sore arm and a headache. Took a 500mg Tylenol and was able to go back to ... Read more
Awaken at night with very sore arm and a headache. Took a 500mg Tylenol and was able to go back to sleep. Headache resolved the next morning. Sore arm resolved in about 2 days
66 2021-02-03 pain in extremity Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in he... Read more
Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in her arm and her knees are a little achy; Chills; first dose was on 05Jan2021/ second one yesterday 19Jan2021; Kind of like the flu, like she was hit by a truck; had trouble getting off of the sofa; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), via an unspecified route of administration on 19Jan2021 11:37 at a single dose on right arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER9231, expiry date: Apr2021), via an unspecified route of administration on 05Jan2021 at single dose in left arm for COVID-19 immunization. The patient experienced body aches, mostly in her arm and her knees are a little achy on 19Jan2021 22:00, chills on 19Jan2021, and kind of like the flu, like she was hit by a truck, had trouble getting off of the sofa, all on Jan2021. The patient just got her second Pfizer COVID Vaccine. She experienced nothing with the first dose. She had the second one yesterday 19Jan2021. Last night she had body aches and chills. The chills are completely gone and the body aches are 85%-90% better. She called out of work today, unknowing how long these would last, and her boss told her to get this reported. She does feel better. She was warned of the second dose being more ferocious. She felt great all day. Around 10 PM the body aches started. Kind of like the flu, like she was hit by a truck. She had trouble getting off of the sofa. They told her not to take Advil as it would make the vaccine not work as good. She is used to taking Advil. She confirmed she did not take the Advil. She took Tylenol instead, this morning. She had to go out and get some. The nurse told her when she got the second dose that she would have side effects and she would feel it. Her arm was sore so she circled it around. She went this morning to the pharmacy to get the Tylenol. She is unsure if because she was moving around, or because of the Tylenol that she feels so much better. Maybe like she could even go into work at Noon. She did not take Advil or Tylenol last night, which maybe that is why she was sore. The chills only lasted about half an hour last night and 15 minutes today. Body aches had greatly improved. It is mostly in her arm and her knees are a little achy. They are normally not. She is 85% better. It is going away as we speak. The outcome of the event Body aches, Pain in arm, knee pain was recovering, chills was recovered on 20Jan2021, while for the other events was unknown.
66 2021-02-03 numbness, inability to speak, weakness Immediate adverse reaction: Trouble breathing. Numbness L fingers, then jaw, then R fingers. Blood P... Read more
Immediate adverse reaction: Trouble breathing. Numbness L fingers, then jaw, then R fingers. Blood Pressure Emergency Room High. Fast heartbeat. Dizziness. Weakness. Trouble communicating-at a loss for words. Took Lisinopril-HCTZ20-12.5 while being monitored by RNs for BP and heart rate. 5 minutes thereafter, fuzzy cloud lifted from brain. Eventually felt OK to leave site.
66 2021-02-03 discomfort Patient complained of pressure/swelling of left axilla and left side of neck. BP 112/60 (repeat, 110... Read more
Patient complained of pressure/swelling of left axilla and left side of neck. BP 112/60 (repeat, 110/69), pulse 73 (repeat 72), and O2 sat 96% to 97%. Drank apple juice and water - felt well enough 40 minutes later to leave for home.
66 2021-02-03 feeling hot tingling in mouth and nose with metallic taste metallic taste also went down throat with heat sensat... Read more
tingling in mouth and nose with metallic taste metallic taste also went down throat with heat sensation and sore throat
66 2021-02-04 numbness facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolv... Read more
facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolved), neck pain (ongoing, possible fibromyalgia flare); ocular irritation redness (ongoing, possibly unrelated)
66 2021-02-04 pain in extremity her wrist is swollen/just above the bone on her wrist it is swollen; it is like a burning; she has r... Read more
her wrist is swollen/just above the bone on her wrist it is swollen; it is like a burning; she has really bad arthritis like she has had a knee replacement/her arthritis is really bad/it just flared up; She had a little pain in her leg; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (Pfizer BioNTech COVID 19 vaccine, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration on 12Jan2021 09:30 at single dose in Left upper arm for covid-19 immunization. Vaccination Facility Type was at a hospital, they had a vaccine clinic set up. Vaccine Administered at Facility was No. Medical history included arthritis, she has had a knee replacement, she was allergic to anti-inflammatory medicines. Family history was none. There were no concomitant medications. No other vaccines was administered on same date of the bnt162b2. Prior Vaccinations (within 4 weeks) was None. No events occurred following prior vaccinations. Patient was calling about a question with the COVID-19 vaccine. She got it on Tuesday 12Jan2021 and she wanted to know if she could get a reaction now. Yesterday (20Jan2021) she noticed, she had really bad arthritis like she has had a knee replacement and she has it her hands and yesterday she noticed her wrist was swollen and she didn't know if it could have been where she had arthritis or could it be side effect? She just didn't know if she should call her orthopedic doctor. She said the joint at the wrist, it was like the side of her hand, it was the side where your pinky was, just above the bone on her wrist it was swollen. It was swollen normally but it usually didn't hurt like this, it was like a burning but it maybe her arthritis acting up but she did not know. She said the pain and swelling began yesterday 20Jan2021. Her wrist was swollen and it was like a burning was reported as worsened. She had a little pain in her leg the other day on 17Jan2021 but just coughed it up. It was all on the left side which was the same side she got the injection on. She didn't think anything of the leg pain and it went away. The pain in her leg has resolved completely. The only other thing was her arthritis was really bad, it just seemed that it just flared up but she was wondering if it could be a side effect. The events didn't require a visit to emergency room or physician office. The outcome of "She had a little pain in her leg" was recovered in Jan2021, while outcome of other events was unknown.
66 2021-02-05 pain in extremity I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my hea... Read more
I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my heart rate doubled. It took around an hour for my heart rate to slow down again. By bedtime all I had was a sore arm. That was gone within 24 hours.
66 2021-02-05 migraine Mild to Severe migraine still have it. Chills and stiff neck.
66 2021-02-06 pain in extremity 9th day after injection, once again have 1.5 inch diameter redness, hardness, itching, warm to touch... Read more
9th day after injection, once again have 1.5 inch diameter redness, hardness, itching, warm to touch. Arm again moderate sore. Same reaction after initial shot which cleared up around 5th day. No other symptoms.
66 2021-02-06 weakness Tiredness (no energy) Headache Chills Fever 107 Injection site redness Nausea
66 2021-02-07 weakness 1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Bena... Read more
1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Benadryl given with good effect. C/O nausea and decreased appetite 1/30 received PRN Zofran with good effect. No further complaints 2/1
66 2021-02-07 seizure 24 hours after second Pfizer dose, multiple Seizure activity occurred. Client was transported to the... Read more
24 hours after second Pfizer dose, multiple Seizure activity occurred. Client was transported to the hospital for a 3 day stay. During that visit client was sedated and has little recall of hospitalization. Medication upon discharge - Keppra 750mg BID. First dose Pfizer 1/12/21 no reaction, not even sore arm
66 2021-02-07 numbness, tingling Approximately 2 hours after her first COVID-19 Vaccine dose, patient began to feel right arm numbnes... Read more
Approximately 2 hours after her first COVID-19 Vaccine dose, patient began to feel right arm numbness and tingling in her hand. This progressed to right leg numbness, tingling and weakness and right lower face tingling. Patient denied any facial droop, slurred speech, confusion or dizziness. Patient reports that symptoms peaked the night of the vaccine around 9 or 10pm and had gotten better but not totally resolved. She was advised to go to the ER and was admitted. MRI showed an acute infarct in the left basal ganglia. CTA showed "short segment moderately severe narrowing of the M1 segment of the right MCA." Neurologist was consulted and determined it to be coincidental that the patient had her COVID vaccine the same day.
66 2021-02-07 weakness Felt weak
66 2021-02-07 night sweats, tremor vomit once shakes
66 2021-02-08 discomfort Report discomfort to mid-chest with radiation to mid back. Treatment: Advil. Outcome: no improvement... Read more
Report discomfort to mid-chest with radiation to mid back. Treatment: Advil. Outcome: no improvement, continues to work, does not interfere with ADLS. Recommend to follow-up primary care doctor.
66 2021-02-08 tingling left eye pain and redness, red patches and swelling under left eye started out slight and has swolle... Read more
left eye pain and redness, red patches and swelling under left eye started out slight and has swollen bag under eye, itchy eyes, redness and tingling in the area has also moved to my upper eyelid and eyebrow/temple area. Left cheek and left side of head are tingling.
66 2021-02-09 weakness Client alerted onsite EMS concerning weakness. VS: B/P 130/60, Heart rate 72. Client stated she felt... Read more
Client alerted onsite EMS concerning weakness. VS: B/P 130/60, Heart rate 72. Client stated she felt better and asked her husband to drive. Client released home at 8:28 am.
66 2021-02-09 cold extremities Did the adverse event start after the first or second vaccination? both Date and time of vaccinatio... Read more
Did the adverse event start after the first or second vaccination? both Date and time of vaccination: (list both if they received both shots): 1-6-2021 @ approx 10:15am Pfizer LOT # EL3246 1-27-2021 @ approx 11AM Pfizer LOT # EL9262 Date and time adverse event started: 1-31-2021 at approx 8:30am, cold hands/feet, nausea, HA, pain to bilateral eye, mid lower back aches radiating to upper. today 2-5-2021 losing voice, all symptoms are reported to be intermittent Pfizer LOT # EL3246
66 2021-02-09 flushing Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2... Read more
Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2nd dose pfizer vaccine given; after obtaining chart pt reports "feeling flushed, and then redness/rash on chest, and blood pressure go up". Pt given epi during rapid response; Pt reported a headache at this time. Pt denies dizziness, nausea, diarrhea, sob, no facial swelling, no lip swelling; no dysphagia; RR equal non-labored; Alert and orientated x4;
66 2021-02-09 pain in extremity Rash more like itchy area above the injection site; Rash more like itchy area above the injection si... Read more
Rash more like itchy area above the injection site; Rash more like itchy area above the injection site; Sore arm; reconstitution problem / 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS; patient received approximately "double strength dose"/ 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS, the recommended 0.3ml dose was then administered to the patient; medical history included rheumatoid arthritis; medical history included rheumatoid arthritis; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, exp. date May2021) via unspecified route of administration on 25Jan2021 at 11:45am at 0.3 mL single dose in right deltoid for COVID-19 immunization. The patient's medical history included ongoing rheumatoid arthritis. The patient's concomitant medications included ongoing hydroxychloroquine for rheumatoid arthritis. The patient experienced sore arm on 26Jan2021, rash more like itchy area above the injection site on 27Jan2021. The patient had no treatment. Pharmacist stated is was a reconstitution problem. He did not have a syringe bigger than 1 ml so he put 0.8 ml, got distracted and forgot to put the rest of the diluent. 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS. The recommended 0.3ml dose was then administered to the patient. The patient received approximately "double strength dose". After applying the vaccine, he remembered that he did finish the preparation of the vaccine. The patient is a co-worker and they have been checking on her to see if she developed any adverse effect. The event was reported as non-serious. The patient recovered from sore arm. The patient was covering from rash more like itchy area above the injection site.
66 2021-02-09 tingling, numbness This is a 66-year-old female past history of asthma, COPD, carotid stenosis who presents with a COVI... Read more
This is a 66-year-old female past history of asthma, COPD, carotid stenosis who presents with a COVID-19 vaccine side effect. Patient states she got her second Covid vaccine this morning and shortly thereafter noticed numbness in her left arm. She states that the numbness is directly in line with the injection location. She states it has not improved nor worsened over the course of the day. She still has strength in her left upper extremity. She states that within the first hour or 2 after injection and she noted some perioral numbness. She states that her lips were tingling and then she noted on her cheeks and then down the sides of her neck. She states she never had any difficulty swallowing or difficulty breathing. She states that she became concerned because this is very atypical for her as she has never had paresthesias in these locations. Patient states that she was encouraged by her doctor to come to the emergency department. Over the past 10 hours that she has been in the waiting room her facial symptoms have improved. She states that her lips only now feel like she is "coming back from Novocain ". She states that she no longer has the facial paresthesias no other paresthesias in her neck. She states that the paresthesias in her arm are unchanged. She denies any fever, chills, nausea, vomiting, dizziness, urticaria, facial swelling, oral swelling, pharyngeal swelling. Facial paresthesias are bilateral and without droop of the face.
66 2021-02-09 pain in extremity bump in her arm had gone up and down in feeling, she has a tiny black mark in the middle; there was ... Read more
bump in her arm had gone up and down in feeling, she has a tiny black mark in the middle; there was soreness; bleeding from where the nurse injected her; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration injected into right arm on 24Jan2021 at 05:45PM or 05:44PM at single dose for COVID-19 vaccination. Medical history included Graves' disease, she was diagnosed in the 1980s with Graves' disease, which became Hashimoto's so she took Synthroid, because she believes it switched from hyperthyroid to hypothyroid, and Lichen sclerosus. Concomitant medication included levothyroxine sodium (SYNTHROID) for Graves' disease and Hashimoto's, furosemide, and fluocinolone acetonide for Lichen sclerosus. On 24Jan2021, the patient experienced bump in the arm, She said that the bump in her arm had gone up and down in feeling, she has a tiny black mark in the middle, at its largest it was bigger than a half dollar, now it's a quarter. She said that they did no treatment, there was soreness, but it has not required treatment, the discomfort was bearable. She said after she was given her shot she was bleeding nurse from where the nurse injected her, she sometimes did that, it was not related at all, blood dripped down her arm, she had to wipe her arm. The outcome of the events was unknown. She said she would like to know if Pfizer had info information about whether she should have her supplements, like Vitamin B, C, D and her Furosemide, and whether she could have Zinc or Magnesium as well. Information about Batch/Lot number has been requested.; Sender's Comments: Based on the information available a possible contribution of the vaccination with BNT162B2 towards the onset of vaccination site bleeding cannot be fully excluded.
66 2021-02-09 pain in extremity chills; fatigue; headache; soreness in her arm; This is a spontaneous report from a contactable cons... Read more
chills; fatigue; headache; soreness in her arm; This is a spontaneous report from a contactable consumer reported for herself. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PFREL1283), via an unspecified route of administration on left arm on 13Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included diabetic, highwood pressure, kidney issues. The patient's concomitant medications were not reported. The patient previously took hydrocodone, morphine, oxycontin, metformin, trulicity, all experienced drug allergy. The patient experienced chills, fatigue, headache, soreness in her arm, all on 13Jan2021 16:00 with outcome of recovered on 14Jan2021 16:00. This last for about 24 hrs. No treatment received for these events.
66 2021-02-16 pain in extremity Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days ... Read more
Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days Upper arm still sore after 12 days. Pain on movement and unable to sleep on that side, as the arm pain awakens me. Also, the injection seemed to be placed extremely high on the arm, about an inch from top of shoulder and in the center/front or arm where it more bone/less muscle
66 2021-02-16 feeling hot, flushing Patient began to feel flushed, hot. No nausea or vomiting. No shortness of breath or light headed ... Read more
Patient began to feel flushed, hot. No nausea or vomiting. No shortness of breath or light headed ness. O2 sat 100%, resp 18, BP 140/76, heart rate 67. Symptoms resolved and patient discharged from clinic
66 2021-02-17 feeling hot Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest... Read more
Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest pain; body ache; high fever; fatigue; profuse sweating; belabored breathing; hot; butterfly rash of face; This is a spontaneous report from a contactable physician (patient). A 66-year-old female (Not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 11Feb2021 14:30 at single dose for covid-19 immunization. Medical history included hypothyroidism, hypertension, hypercholesterolemia, breast cancer, osteoporosis, ligamentous RA, degenerative joint disease (DJD). The patient had known allergies to cilantro, cephalosporins, all morphine and morphine derivatives, Herceptin, astralogous mushrooms, gadolinium dye, fentanyl. The patient's concomitant medications reported as other medications in two weeks was yes.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, eye pain, earache on side of shot, itching both arms, severe jaw pain, severe chest pain, body ache and high fever &fatigue - profuse sweating, belabored breathing hot butterfly rash of face on 12Feb2021 at time of 06:00 AM. AEs resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient received Prednisone 80 mg and Benadryl 50 mg as treatment. Prior to vaccination, the patient was diagnosed with COVID-19. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab and PCR test: negative on 09Feb2021. The outcome of events was recovering. Information on Lot/Batch has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-02-18 pain in extremity dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issue... Read more
dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issues (falling into her right side); This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiration Date: May2021), via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included cancer survivor, type 2 diabetes mellitus, and surgery of the left hand in 2020. Concomitant medications included the second dose of varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on 12Jan2021 for immunization. The patient previously received the first dose of the varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on an unknown date for immunization. On 02Feb2021, the patient experienced swelling and pain in arm and felt sleepy. On 03Feb2021, the patient fell on the table due to dizziness. The patient had to use her cane more to get around. On an unknown date in Feb2021, the patient had weakness in the right eye and balance issues (falling into her right side). The clinical outcomes of the dizziness, swelling in the arm, and weakness in the right eye were recovering; while that of the pain in the arm was not recovered. The clinical outcomes of the sleepiness, fall, and balance issues (falling into her right side), were unknown.
66 2021-02-21 pain in extremity, night sweats Body aches, fever 99.8, chills, chattering teeth, general feeling unwell. Pounding headache, fatigue... Read more
Body aches, fever 99.8, chills, chattering teeth, general feeling unwell. Pounding headache, fatigue, really sore arm. Night sweats. Lasted about 48 hours. I'm still waking up with a pounding headache every morning. Still lingering sense of unwellness.
66 2021-02-21 tingling, breast pain, pain in extremity Pt states severe pain in right inner elbow and outer breast. Pain and tingling started in left arm ... Read more
Pt states severe pain in right inner elbow and outer breast. Pain and tingling started in left arm and hand as well.
66 2021-02-21 unresponsive to stimuli Pt went to unconscious; reported SOB and then slowly went unresponsive. code blue called immediately... Read more
Pt went to unconscious; reported SOB and then slowly went unresponsive. code blue called immediately, patient still with BP WNL, oxygenating fine, had a pulse. gag reflex+ when oral airway placed. Taken to ED w/ team. Epi IM given, Ativan given, Benadryl given, glucose given. Pt became awake and alert, talking, observed at ED, then discharged to home at 1226
66 2021-02-22 pain in extremity 2 days after vaccination right thighs and right leg started to have pain similar to pain I got with ... Read more
2 days after vaccination right thighs and right leg started to have pain similar to pain I got with polymyalgia rheumatica that I have had in past and I though it was a flare up. A couple of days after that right leg started to swell and was warm. Went to ER on 1/29/2021 and had doppler which showed blood clots from groin area to below the knee. I was placed on Xarelto at that time. Got 2nd dose and about 24 hours latter back of thighs started to hurt again. Called doctor and applied heat and elevation and had no new swelling but I remain on Xeralto. Not sure if it was related but I have had no history of blood clots. 2 years previously broke my right patella and was with brace and no weight bearing for about 8 weeks and brace for 12 weeks without clot issues. Traveled by car a couple thousand miles last year and no issues.
66 2021-02-22 pain in extremity About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints ... Read more
About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints and having breathing problems. i was just sic. or like i had the flu or covid again. went on through the night. was up all night. my arm was just killing me. The next morning i was full on sick. the nausea was intense my temp throughout day was 99.6 and 99.9 . out of breath. That night i went to bed and woke up at midnight and was drenched my hair was soaked Got up at showered. at the 3:30 woke up again totally drenched. yesterday i woke up and 6:00 am i was feeling better but still trouble breathing but everything else was gone. I was tired still. About 10:30 yesterday Everything was fine. I do still have a little trouble breathing but not as bad.
66 2021-02-22 feeling cold Chills, feeling cold
66 2021-02-22 numbness Facial numbness left side only
66 2021-02-22 weakness Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day ha... Read more
Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day has vomiting, chill and weakness which lasted 6 days
66 2021-02-23 pain in extremity The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to tha... Read more
The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to that dose. (Had arm pain and mild chills and fatigue). The day after dose two above noted fullness and discomfort in feet, On the second day after, had early erythematous (non-puritic) rash, mild multi-joint discomfort, 100 deg fever, and shaking chills. Doctor on call said to use judgment on starting Prednisone, since hope that this would stabilize. However, progressed and at 9am on the third day after vaccine started prednisone 40mg. At the worst, had to be dressed by husband due to pain and stiffness in upper extremities, widespread erythematous rash, fullness of skin, joint swelling.
66 2021-02-23 night sweats Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headac... Read more
Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headache (which I never get) low grade fever; Day 3:Hives and itche sin addition to dry cough; Day 4 - Hives deep red, full torso and back, top of legs and pubic areas. Deep and extreme.Chills Steady, Night Hard vomiting, Hives, Soaking Night sweats (never had before), Temp 101.5. Day 5 Morning - rapid test negative, fever 99.9. Started Ibuprofen Day 6 - Hives same - extremely dark and red. itchy. # day swab test was POSITIVE. Put on Prednisone. Day 7 - Fever normal, Hives going down but still ugly. Not sure whether this was really an adverse event as it was a positive test result AFTER the vaccine. I am an allergig person whose eosinophils report for duty quickly and obviously too much! I will assume that they were the result of the virus and NOT the drug as the drug does not have an active virus included. Your call.
66 2021-02-23 muscle spasms fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root ... Read more
fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root canal on day 4 with "dying nerve", butterfly (lupus like) rash on face day 4, "covid arm" day 4 with tennis ball size red knot around injection site that extended down arm over next several days, winded for several days, fatigue and shortness of breath.
66 2021-02-24 flushing Nausea, flushed, feeling anxious, evaluated by EMS-cleared
66 2021-02-24 flushing Patient received her second dose of Pfizer vaccine today at 1230 today. Approximately 15 minutes la... Read more
Patient received her second dose of Pfizer vaccine today at 1230 today. Approximately 15 minutes later at 1246 she started to feel a flushed face, nasal and sinus congestion and stated that her throat felt as if it was swelling. Benadryl 50 mg orally was administered. VS were checked BP 128/80, HR 82. Pt stated she was feeling improved at 1315 and stated her throat felt much better, denies feeling swelling in her throat. No evidence of mouth, tongue or lip swelling, no evidence of angioedema. No evidence of respiratory distress, no wheezing, speaking in full sentences. No rash. Reassessment @ 1345: One hour after patient received benadryl she stated she felt much improved aside from mild body itching. Requesting to leave with husband. Advised to continue benadryl 50 mg every 6 hours as needed for symptomatic and follow up with her primary care doctor and allergist.
66 2021-02-24 pain in extremity Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the sym... Read more
Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the symptoms. Fatigue (not able to complete the routine daily walk of 3 miles) the day after vaccination for one day.
66 2021-02-24 flushing Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing.... Read more
Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing. These symptoms came in waves and is a normal reaction I get with medication I am sensitive to. However because I not having a normal reaction, I was told to go to an emergency room for a EKG. I knew this wasn?t a heart event, but a reaction to the vaccine. It is a normal reaction for me. I?ve dealt with it most of my life.
66 2021-02-24 numbness mouth sores; Numbness of left arm, shoulder and left side of face; some tongue swelling.; This is a... Read more
mouth sores; Numbness of left arm, shoulder and left side of face; some tongue swelling.; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 66 years, on 10Feb2021 09:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa drugs) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took tetracyclines and experienced drug hypersensitivity, pneumovax vaccin and experienced drug hypersensitivity. On 10Feb2021, the patient experienced numbness of left arm, shoulder and left side of face and some tongue swelling. The patient applied ice for several hours. After 5 hours or so, the face and tongue were back to normal. The following day (11Feb2021), they noticed mouth sores. The patient used salt water rinse to help. The patient asked if she should be avoiding the 2nd dose scheduled in 18 days as a result of this reaction. Therapeutic measures were taken as a result of numbness of left arm, shoulder and left side of face (hypoaesthesia), some tongue swelling. (swollen tongue), mouth sores (stomatitis). The outcome of the events was recovering. Information on the lot/batch number has been requested.
66 2021-02-25 flushing Client c/o flush feeling 3 minutes after receiving vaccine. Client is seen and assessed by EMS and ... Read more
Client c/o flush feeling 3 minutes after receiving vaccine. Client is seen and assessed by EMS and VS are B/P 128/86, HR-90, O2 98. Client denies any other symptoms and verbalizes that she no longer was having symptoms and velar by EMS.
66 2021-02-25 tenderness, numbness I experienced tenderness, sensitivity to touch, swelling, and numbness (ALL SLIGHT) to the left side... Read more
I experienced tenderness, sensitivity to touch, swelling, and numbness (ALL SLIGHT) to the left side of my face, including around my eye, jaw, and lips.
66 2021-02-25 flushing Patient was given the Pfizer vaccine at a drive through clinic. While waiting for a reaction - about... Read more
Patient was given the Pfizer vaccine at a drive through clinic. While waiting for a reaction - about 15 to 20 minutes the patient developed a flush feeling and thickness of the tongue. Patient was given an epi pen shot to her left thigh and felt better within minutes. Patient refused to be transported to the hospital for evaluation.
66 2021-02-25 weakness headache; sweats; feverish; chills; low blood sugar symptoms; weakness; This is a spontaneous report... Read more
headache; sweats; feverish; chills; low blood sugar symptoms; weakness; This is a spontaneous report from a contactable healthcare professional. This 66-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot EL3247) on 24Jan2021 at 11:15 AM at left arm for COVID-19 immunization in hospital. Historical vaccine included first dose for BNT162B2 (lot EK5730) on 02Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Medical history included hypo thyroid, parox afib, high blood pressure (HBP), obesity and allergies: bupropion hydrochloride (WELLBUTRIN), soy. Concomitant drugs included metoprolol, apixaban (ELIQUIS), fluoxetine hydrochloride (PROZAC), losartan potassium (COZAAR), thyroid (ARMOUR THYROID) and more. On the day of injection on 24Jan2021 at 04:00 PM, the patient had low blood sugar symptoms, weakness, which resolved in a few hours. On second day, symptoms of low Blood sugar, sweats, feverish, chills, on third day feverish symptoms of low blood sugar, sweats, feverish, headache. No treatment was received. The outcome the events was unknown.
66 2021-02-26 pain in extremity Headache for 5 days. Extremely sore arm for 5 days. Unusual Fatigue 3 days.
66 2021-02-26 pain in extremity Nausea Achy Chills Headache Sore arm at site Fatigue
66 2021-02-26 feeling cold Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank... Read more
Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank about 20 oz of Crystal Light Peach Tea over night. Got up at 5am to get more to drink and find another place to rest. went into my kitchen to fill container and passed out. Woke a few seconds later. Left side of my forehead was bruised and swollen above left eye. Over the last 4 days both eyes an cheeks are bruised. All day felt like I had the flu without the fever. I did not go to the hospital.
66 2021-02-27 discomfort Chills, progressed to fever of 100 F, muscle aches, swelling and discomfort in left armpit
66 2021-02-27 pain in extremity Headache Fatigue-minor Sore arm
66 2021-02-27 tingling, numbness mild bi-lateral numbness and tingling of hands and FINGERS during morning of 2/11 (3 or 4 on a scale... Read more
mild bi-lateral numbness and tingling of hands and FINGERS during morning of 2/11 (3 or 4 on a scale of 10); does not interfere with ADL - right side: Becoming interment during the afternoon and disappearing on the right by evening. - Left side: tingle and numbness lasted longer. became intermittent during the evening of 2/11 Day of 2/12: experienced occasional tingling on right and more frequently on left. 2/13: tingling mostly gone However, will still occasionally notice a small bit of residual tingling and numbness 2+ weeks later. low frequency, 1 or 2 on a scale of 10
66 2021-02-28 feeling hot Before I left the hospital parking lot I could taste the drug in my moth. By the time I got home ... Read more
Before I left the hospital parking lot I could taste the drug in my moth. By the time I got home I had the dry heaves. I was also alternating hot and cold. This went from about 7 pm to 8 AM the next day. That day I had a head ache which I normally do not have.
66 2021-02-28 flushing Client c/o general flush feeling dryness of mouth and sweating. Client verbalized that symptoms occ... Read more
Client c/o general flush feeling dryness of mouth and sweating. Client verbalized that symptoms occurred immediately after receiving vaccine. Client seen and assessed by EMS an Vital signs are B/P 147/82, HR 80, O2 100%. Pt. voice that her anxiety level increased when receiving vaccine but now has decreased and symptoms decreased during observation. Second round of vitals B/P 139/82, HR 76, O2 99%. Client then verbalized that she is no longer having the sensation and asked to go home after 45 minutes of observation. Client denied the need to go to or be taken to the hospital and was cleared to go home by EMS. No physical reaction noted.
66 2021-02-28 hot flush, flushing Face flushing, " rolling hot flashes", head fullness. This lasted about 10 to 15 minutes, intermitte... Read more
Face flushing, " rolling hot flashes", head fullness. This lasted about 10 to 15 minutes, intermittently then dissipated.
66 2021-02-28 flushing Flushing at 1130, fatigue during first day, extreme joint and muscle pain second day
66 2021-02-28 muscle spasms Headache in the back of my neck radiating up into the back of my head; Headache in the back of my ne... Read more
Headache in the back of my neck radiating up into the back of my head; Headache in the back of my neck radiating up into the back of my head; Projectile vomiting; Dry heaves; Fever; Chills; Muscle spasms; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported) on 26Jan2021 (10:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included allergy-induced asthma; Celiac disease; bradycardia; was a pacemaker user (for bradycardia); sulpha allergy; and latex allergy. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), alprazolam, lisinopril, montelukast, and other unspecified medications. The patient previously took cephalexine, and had allergy. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on the left arm on 07Jan2021 (when the patient was 66 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 26Jan2021 (23:00), the patient had headache in the back of the neck, radiating up into the back of the head; projectile vomiting; dry heaves; fever; chills; muscle spasms; and swollen glands. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache in the back of the neck, radiating up into the back of the head', 'projectile vomiting', 'dry heaves', 'fever', 'chills', 'muscle spasms' and 'swollen glands', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
66 2021-02-28 weakness Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room.... Read more
Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room. While she was sitting down patient started to complain of itchiness at injection site and felt like needed to scratch arm about 3 times, lasted only a minute. Started to feel lightheaded about 5 minutes after sitting down in waitng arae and notified observer. Felt weak and lighthed. Offered a wheelchair but refused and able to walk back to examination room. Taking Topamax this am for headaches, no other medications. Has COPD. Caring for adult daughter who is disabled and her husband left for a trip last Wednesday and back tonight. Patient often has interrupted sleep and up every couple hours with daughter. She has another daughter who will come and help at times but no one else around due to COVID concerns. Ate granola, blueberries, yogurt for breakfast this am Offered water in exam room, crackers and apple juice but patient refused. States has IBS and not want to eat other things In exam room feeling anxious, but the lightedness disappeared within 10 minutes. B/P decreased to 128/72. No nausea, abdominal pain, SOB. Denies any new illness. Has chronic cough with COPD Patient alert and oriented during entire visit and pleasant in conversation.
66 2021-02-28 migraine The day after my first vaccination at 3:15 PM I started getting visual auras and then migraine whic... Read more
The day after my first vaccination at 3:15 PM I started getting visual auras and then migraine which lasted about 4 hours. I have had up 7 more since then and after my 2nd vaccine. Dr. thought it might be related since I have no history of chronic migraines. All past were over 16 years ago and related to hormonal changes.
66 2021-02-28 feeling hot tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come... Read more
tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old) as a single dose for covid-19 immunisation . Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas). The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks. On 27Jan2021 The patient reported she was sick last night, tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.
66 2021-02-28 tingling, cold extremities, numbness veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and... Read more
veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and Hands; Tingling in Arm and Hands; some pain in the injection arm; muscles pain in the hands; a freezing cold sensation in her hands/her hands were frozen for 3-4 seconds; I would wake up with one hand completely numb; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included osteopenia and osteoporosis. She was shrinking, her height was about 5 feet 5 inches, she used to be 5 feet 7 inches. Concomitant medication included calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D3 [CALCIUM CARBONATE;COLECALCIFEROL]), fish oil, vitamin e nos (OMEGA 3 [FISH OIL;VITAMIN E NOS]), vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]), and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). It was reported that on 09Jan2021, she received the first dose of the vaccine. She started to feel tingling and numbness in both hands the same day after the vaccine was administered. She states she also had some pain in the injection arm and that the numbness/tingling was off and on and traveled to her arms occasionally. She states, "I would wake up with one hand completely numb and it was worse the first 15 days but is getting better and is a little less than before." She states she would have a freezing cold sensation in her hands occasionally and she states her veins were more prominent and visible in her hands/arms around the 13th day after getting the vaccine. She further reported that when she received the vaccine, that same afternoon she started feeling a tingling sensation in the hands and arms, also a sensation of numbness like electrical accompanied with muscle pain. The Numbness and Tingling was on and off and well as the muscles pain in the hands. It was more noticeable 13-14 days later now. She would be sleeping at night and would wake up because of the sensation in the left hand or on the other right hand. The hands would wake her up. She provides an example of its like when your foot is asleep with the pins and needles, because you had your foot squished under for a while, like the foot falling asleep but in this case she wasn't doing anything and would have that feeling. Once or Twice when having breakfast she noticed that her hands were frozen for 3-4 seconds. After the 13 or 14 days, things are milder but now she still has the sensation, its not so often but milder. She also notices the veins in her hands are still swollen in the arms, its like the veins popped up. She is still having this. She is concerned since she is suppose to get second injection on 30Jan2021, she is concerned if she should still it. She is nervous. She clarifies that the first dose was on 09Jan2021 at 10 or 10:15 AM. On the same day is when she started noticing the Numbness and tingling in the Hands and arms on 09Jan2021. She noticed the Veins popping on 22Jan2021. Caller clarifies that she has no side effects in the legs, she was just providing that comment as an example. The outcome numbness in arms and hands, tingling in arm and hands, wake up with one hand completely numb, was recovering; pain in the injection arm, muscles pain in the hands, freezing cold sensation in her hands was unknown; and veins in her hands are still swollen in the arms was not recovered. The reporter assessed the events as non-serious.
66 2021-03-02 tingling About 3 minutes after COVID-19 Injection, patient started to have numbness in lips, tongue felt swol... Read more
About 3 minutes after COVID-19 Injection, patient started to have numbness in lips, tongue felt swollen, chest and abdomen tingling and tightness. Lasted about 5 minutes and then resolved.
66 2021-03-02 weakness I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous... Read more
I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EM9810) at her left arm, at 11:00AM 17Feb2021, for Covid-19 immunization. The patient received her first injection (Lot number EL9765) on 27Jan2021 10:15AM at her left arm. The patient's medical history was not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient was fine for 10 hours afterwards, went to bed, woke up disoriented weak and dizzy. She passed out going down stairs, came to on the floor at the bottom of the stairs, bloody nose, about an hour later passed out again in the kitchen and woke up on the floor. No warning either time, like light switch being turned off. The patient never had a reaction to anything before, never passed out before. She felt better at time of reporting. The adverse events happened at 07:00 AM 18Feb2021. The patient had not received any treatment for the events and not covered from the events. The patient had no Covid prior vaccination and Covid was not tested post vaccination.
66 2021-03-02 migraine Some achey-ness and a bit of chills. Bad migraine with very frequent (every 20-30 seconds) bolts of... Read more
Some achey-ness and a bit of chills. Bad migraine with very frequent (every 20-30 seconds) bolts of very sharp pain in my head in addition to migraine. This went on for 30 hours. No treatment...just waited it out and used cool packs on head. Also had very enlarged tender nodes under my left arm which are going away.
66 2021-03-02 breast pain, muscle spasms burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left... Read more
burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; charlie horse like cramps in left arm, hand and shoulder.; left breast swelled up; left armpit swelled up; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263), via an unspecified route of administration (on left arm) on 27Jan2021 10:00 (at the age of 66 -years-old), single dose for COVID-19 immunization. Medical history included back surgery, knee surgery both on 2018. The patient's concomitant medications were not reported. Caller received 27Jan2021: 15 min after injection burning down her left arm, left breast and axillary swollen painful, charlie horse like cramps in left arm, hand and shoulder. She is drinking water, taking Tylenol, and using a heating pad but symptoms are persisting. Consumer states she is getting some interesting side effects from the vaccine. Adds she received the vaccine on 27Jan2021 10:00AM. Reports within the first 15 minutes she noticed just some burning down her left arm but then her left armpit swelled up; her left breast swelled up and she started to experience charlie horses in her arm. Adds now the pain has come down a little. She has been drinking water, taking Tylenol, and using a heating pad and that has helped a little. The pain comes and goes. It is worse at night when she lies down. Now it is in her hand, charlie horsing in her hand. She thinks maybe the shot got into her lymph nodes. Mentions the swelling her left armpit and breast has gone down some but the pain is still there. Clarifies patient received the first dose of the Pfizer COVID 19 vaccine on 27Jan2021 at 10:00AM on the left arm. She is scheduled for the second dose 24Feb2021. The outcome of the event Swelling arm, Breast swelling, Axillary pain, Axillary lymph nodes enlarged was recovering, other events was not recovered.
66 2021-03-02 feeling cold feel a cold sensation in my groin and in my upper thighs; This is a spontaneous report from a contac... Read more
feel a cold sensation in my groin and in my upper thighs; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at right arm on 31Jan2021 09:45 at a single dose for COVID-19 immunisation. Medical history included liver damage from hepatitis C. Concomitant medications were not reported. On 31Jan2021, the patient reported that she felt fine and walked back to her vehicle. As she began to drive home (after an additional 5 minutes), the patient began to feel a cold sensation in her groin and in her upper thighs. It continued for about 1/2 hour and then subsided. No treatment was received. The outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been requested.
66 2021-03-02 migraine migraine with flashes of light in left eye; migraine with flashes of light in left eye; gets IBS stu... Read more
migraine with flashes of light in left eye; migraine with flashes of light in left eye; gets IBS stuff; has had diarrhea; diarrhea, had a mild version of the diarrhea that seemed to get worse after the vaccine and still ongoing; vessels in hands really dilated and dark blue; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9264), via an unspecified route of administration (arm left) on 30Jan2021 14:00 at SINGLE DOSE for to have some protection against COVID, at 66 years old. Medical history included connective tissue disorder and anti-cardiac lipid antibody problem; she is prone to blood clots from 2001. At that time, she was sent to the hospital and no one could figure out what it was. She was seeing the Rheumatologist and another person, and they knew something was going on and was given Prednisone (from 2001) because her tissues in the joints were swelling and she had trouble with speech. Patient also reported this as some weird connective tissue disorders already and some anti-cardiac lipid antibody problem. It was really weird and had not changed a bit since so she was kind of checking to see if anyone has reported anything like this. She reported that with this weird antibody problem, she is more prone to blood clots and has to be careful with medications with her blood she knows that some breast cancer medicines can do that. She stated this immune thing was never diagnosed. She also had migraine with globes of flashes of light, left eye (does not typically get migraines and has only had 1 in her life and she saw globes of lights in both eyes and had to go to the emergency room and was told it was an ocular migraine and this was also only in the left eye. This was long ago) from an unspecified date. Concomitant medication included low dose steroid (unspecified). The patient previously received flu vaccine on Sep2020 (AE none). No other vaccines were administered on the same day. On 30Jan2021, the patient experienced vessels in hands were really dilated and dark blue 5 hours after vaccination. On 30Jan2021, the patient also experienced IBS stuff and has had diarrhea the last couple of days after getting the COVID vaccine. She took Pepto Bismol to help and had a mild version of the diarrhea that seemed to get worse after the vaccine and still ongoing. On 01Feb2021, the patient experienced migraine with flashes of light in left eye. It was further described as having a weird migraine with flashes of light in the left eye and she got the shot in her left arm and not sure if that makes any difference. She does not typically get migraines and has only had 1 in her life. The migraines started in the morning and lasted about an hour (as reported) and now they are gone and hopes they stay gone (reported as recovering). She wanted to know if she can take TYLENOL or ibuprofen for vaccine. She heard about people getting symptoms after the second dose not the first dose. Events did not require visits to the emergency room or physician office, but stated that if her vision become worse, she would go to the eye infirmary close by. The outcome of the events diarrhea and vessels in hands really dilated and dark blue, gets IBS stuff was not recovered. Outcome of the events migraine with flashes of light in left eye was reported as recovering.
66 2021-03-02 pain in extremity pt states that about a week after getting the covid vax that she has developed severe pain from the ... Read more
pt states that about a week after getting the covid vax that she has developed severe pain from the upper part of her right hip down to her knee. Pt had an appt w/ Dr. on 2/25/2021 regarding her symptoms. She was prescribed tramadol HCL 50mg and methylprednisolone 4mg. Pt states she is going to have to contact her doctor since this medicine is not working and she is still in severe pain. She has been off from work for a week but had to go back and states it is very difficult since she cant hardly get up and down.
66 2021-03-03 pain in extremity I had a headache within an hour of the injection. The next day, my left arm hurt (which was to be e... Read more
I had a headache within an hour of the injection. The next day, my left arm hurt (which was to be expected), muscle aches and pain, headache still, fatigue, shortness of breath and chills. By 8:30 pm I had a temperature of 101.7. I took some Tylenol and took my temperature again at 10:00 pm. It was 100.8. The next morning (3/3/21), I took my temperature again at 6:00 am. It was 101.1. I still had a headache, body aches and fatigue. I took more Tylenol and my temperature was down to 100.8 within an hour. Had a temperature most of the day ranging from 99.5 to 100.0. My normal temperature is usually 97.9. Still very tired. On Thursday March 4th, feeling better. Still a little tired. Temperature is 98.3.
66 2021-03-03 tingling, numbness Patient had numbness and tingling on the left side of her face
66 2021-03-03 pain in extremity Vaccine given in right arm patient then proceeded to experience right arm pain, dizziness, diplopia,... Read more
Vaccine given in right arm patient then proceeded to experience right arm pain, dizziness, diplopia, and unsteadiness.
66 2021-03-03 pain in extremity, feeling hot bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt h... Read more
bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt hot; her arm was hurting; water bubble appear on my arm with fever; fever; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EN6200), via an unspecified route of administration on 16Feb2021 at 09:15 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient was not tested for COVID-19 post vaccination. On 16Feb2021 at 22:00 the patient experienced bled at the injection site; arm is bruised, states there are little fever blisters on the arm, the arm was hurting and the arm felt hot (clarified the whole arm) on 16Feb2021; and water bubble appeared on the arm with fever "later on" on an unknown date in Feb2021. The patient was treated for the bled at injection site, arm felt hot and pain in arm which included cold ice pack and ibuprofen. The events did not require a physician visit or hospitalization. The clinical outcome of the event bled at injection site was recovered on 16Feb2021, the bruising and fever blisters at injection site was recovering, feeling hot and pain in arm was not recovered, water bubble and fever was unknown.
66 2021-03-04 tingling Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/4/2021 8:45 AM Ex... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/4/2021 8:45 AM Expand AllCollapse All COVID VACCINE CLINIC 3/3/2021 Date: 3/3/2021 Subjective Patient is a 66 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L arm tingling. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. PMH includes htn, takes 2.5 mg daily. She denies having issues with bp this am before coming. She ate breakfast earlier this am. No hx of diabetes. Hx of covid-19 infection in December. Not hospitalized. Still struggles with stamina since her illness. Evaluated in ED on 02/20/21 for chest pressure. Negative cardiac work up per pt. She is followed by her pcp. ALLERGY REVIEW OF SYSTEMS: Patient complains of malaise/fatigue (feels tired today.) and shortness of breath (chronic, not with exertion, tires easily. not changed from baseline.) Patient denies chills, fever, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, wheezing, vomiting, abdominal pain and diarrhea L arm numbness/tingling down arm. Negative focal neuro deficits. : Previous Reactions: none Objective Vitals Vitals: 03/03/21 1023 03/03/21 1045 03/03/21 1115 BP: (!) 156/84 (!) 152/89 (!) 147/80 Pulse: 61 76 Resp: 16 14 SpO2: 99% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: General: No visual field deficit. Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Normal range of motion. No muscular tenderness. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. Motor: Motor function is intact. Coordination: Coordination is intact. Gait: Gait is intact. Gait normal. Comments: +5/5 strength against resistance to upper and lower extremities. Psychiatric: Attention and Perception: Attention normal. Mood and Affect: Mood is anxious (slight anxious affect). Speech: Speech normal. Behavior: Behavior normal. Thought Content: Thought content normal. Cognition and Memory: Cognition normal. Judgment: Judgment normal. Pt was taken to bathroom by LPN via wheelchair during her stay. She still felt weak upon her return. No dizziness/lightheadedness. She was given snacks and water x 2. Assessment/Plan Treatment included: water, snacks and reassurance/observation for about 40 minutes Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt improved with snacks and water. Discussed what to monitor and potential anxiety underlying as well. Pt to continue to monitor her bp at home and f/up with pcp if it continues to be elevated >140/90. Pt was able to ambulate out with ease and w/o dizziness/lightheadedness. Pt voiced appreciation of care today. APRN Electronically Signed 3/3/2021 11:21 AM
66 2021-03-04 pain in extremity Sore arm 1st two days Afterwards severe ache and could not lift arm for 3 days Reddish sore on my f... Read more
Sore arm 1st two days Afterwards severe ache and could not lift arm for 3 days Reddish sore on my foot. Very painful. Cannot put weight on it
66 2021-03-04 tremor Systemic: felt like she was going to pass out, short term memory loss-Severe, Systemic: Shakiness-Me... Read more
Systemic: felt like she was going to pass out, short term memory loss-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
66 2021-03-07 inability to speak Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain w... Read more
Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain why she didn't feel well. She woke up feeling well and then quickly became disoriented and vomited. She was then unable to walk or communicate appropriately. Emergency services was called and she was transported to Emergency room. She was diagnosed with a posterior brain CVA and was treated with tpa and now remains hospitalized in the ICU with expressive aphasia and vision loss.
66 2021-03-07 numbness Sore at injection site; numbness to elbow; This is a spontaneous report from a contactable consumer.... Read more
Sore at injection site; numbness to elbow; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: 10T EL 9262), via an unspecified route of administration on 05Feb2021 13:30 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included hypersensitivity allergies: Yes. Concomitant medications included ashwagandha, ascorbic acid (VIT C). On 06Feb2021 04:00, the patient experienced Sore at injection site and numbness to elbow. The patient did not receive treatment for the events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.
66 2021-03-09 pain in extremity having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the... Read more
having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the night; body aches/achy; chills (no fever); nausea; got the sore arm; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318 (not clarified further)), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation and loratadine (CLARITIN), via an unspecified route of administration from 03Feb2021 at an unspecified dose for unspecified indication. Medical history included ongoing High cholesterol and Sleep disorder, both from unknown date. Concomitant medication included alprazolam (XANAX), calcium (CALCIUM), cyanocobalamin (VITAMIN B12), Multivitamin, taking a statin to prevent high cholesterol and L-methylfolate, stated it is like a folic acid drug. Because the patient really can't take anti-depressant she reacted to them all (Unspecified Medications), so that worked for her and helped her to keep up her spirit. The patient reported her side effects. She didn't want to interfere with anything but she was having lots of Gastrointestinal issues which were inconvenient. She was up in the middle of the night, happened not within 48 hour after the first dose of the Pfizer vaccine but around 60 hours after the vaccine, early this morning (06Feb2021) like around 2 am. The patient was having a reaction after the vaccine but they seemed to be like delayed reactions. Not anything with breathing, she had gastrointestinal stuff going on. The patient had chills, no fever, body aches and she was really going to the bathroom nonstop in the night. It seemed to have been like 2 days after she got the shot like they were worst yesterday (05Feb2021). And she experienced achy, chills, nausea, diarrhea and sore arm in Feb2021. She would like to take TYLENOL and IMODIUM and she didn't know what she could take because she didn't want anything to interfere with that as she had been reading a lot. The patient wanted information on IMODIUM to prevent diarrhea, TYLENOL for body aches, chills (no fever), and FLONASE for sinus. The patient did not receive any treatment for the events. The patient actually didn't even take, that morning that day when she was getting the shot, she called the pharmacist to see if she could spray her nose with the FLONASE for sinus and he told her that he didn't think it was a good idea and that maybe she should just take CLARITIN, so she did. But she took CLARITIN that morning (03Feb2021) and she was hoping that didn't interfere. She was just nervous about it as she didn't want that to interfere with the work that it was. The patient was still suffering, less, like she didn't have the diarrhea anymore. She still had a little achy. She did get the sore arm but only for one day, so it wasn't so bad. The action taken in response to the events for loratadine was unknown. The outcome of event diarrhea and got the sore arm was recovered on an unspecified date in Feb2021, of event achy was recovering, of other events was unknown. Information on the lot/batch number has been requested.
66 2021-03-09 weakness injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection si... Read more
injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection site pain, redness, and swelling; headache; chills; muscle and joint pain; muscle and joint pain; nausea; dizziness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via an unspecified route of administration in the left arm on 06Feb2021 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included slightly elevated blood pressure, not taking medication, and COVID prior to vaccination, on an unspecified date. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) and vitamin supplements. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Feb2021 16:00, the patient experienced injection site pain, redness, and swelling; headache, chills, muscle and joint pain, nausea, dizziness and weakness. No treatment was received for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
66 2021-03-11 tremor, seizure, unresponsive to stimuli Had a Seizure and was transported to hospital by Ambulance, was admitted and kept overnite to run te... Read more
Had a Seizure and was transported to hospital by Ambulance, was admitted and kept overnite to run test. Shaking and Unreponsive.
66 2021-03-14 flushing, feeling hot Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; ... Read more
Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and neck red, swollen and hot to the touch.; Similar to a Cortisone flush.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female non-pregnant patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration in the left arm on 29Jan2021 at 16:00 (at the age of 66-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes mellitus, renal disorder fibromyalgia and hypersensitivity (allergies to medications, food, or other products). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received multiple concomitant medication (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021 at 14:00 the patient expereinced face and neck red, swollen and hot to the touch, similar to a cortisone flush. On 31Jan2021 the patient underwent lab tests and procedures which included blood pressure measurement: normal and body temperature: 97.3 (normal). The patient was treated for face and neck red, face and neck red, swollen and hot to the touch similar to a cortisone flush with 50mg of benadryl (MANUFACTURER UNKNOWN). The outcome of the events was recovering. No follow-up attempts are possible. No further information was expected.
66 2021-03-15 pain in extremity Sore arm; They reconstituted Pfizer covid vaccine with sterile water instead of the normal saline an... Read more
Sore arm; They reconstituted Pfizer covid vaccine with sterile water instead of the normal saline and administered to 6 patients; They reconstituted Pfizer covid vaccine with sterile water instead of the normal saline and administered to 6 patients; This is a spontaneous report from a contactable pharmacist. This was regarding patient 2 of 6. A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Expiration date: Apr2021, NDC number: 59267-1000-01), via an unspecified route of administration in left arm on 03Feb2021 at 0.3 mL, single for prevention/ COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1686, Expiration date: Mar2021) at 0.3 ml, single dose in left arm for COVID-19 immunisation. Calling about COVID-19 vaccination. Yesterday (03Feb2021) they mistakenly used sterile water as a diluent and administered it to six patients, so she wanted to report that and talk to someone about what needs to be done. Caller states she thinks everyone getting the COVID shot was getting a sore arm on an unspecified date. This was the second dose. Caller wanted to know if they need to revaccinate those 6 patient again, so they are protected. The caller (pharmacist) stated that they reconstituted Pfizer COVID vaccine with sterile water instead of the normal saline and administered to 6 patients. Investigation assessment was none. The events were considered as non-serious by the pharmacist. The outcome of the events was unknown. A causal relationship between bnt162b2 and sore arm was assessed as being related by the pharmacist.
66 2021-03-15 night sweats, numbness, nerve pain muscle and nerve on both side of her face and the area along the back of both ears on the back head ... Read more
muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; From thumb finger till middle figure of both hands are numb especially after getting up daily.; The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention); Both gums are very soreness and distention; Both gums are very soreness and distention; Stuffy nose; night sweats; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 66-year-old, on 20Feb2021, single dose for COVID-19 immunization. Relevant medical history included diabetes. The patient had no known allergies. Patient is not pregnant. Concomitant medications included metformin, thiamine hydrochloride (VITAMIN B1 [THIAMINE HYDROCHLORIDE]) taken for covid-19 immunisation; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (left arm), at the age of 66-year-old, on 23Jan2021, single dose for COVID-19 immunization and experienced muscle and nerve on both side of face (especial jawline area) are uncomfortable. On 21Feb2021 at 07:00 am, her muscle and nerve on both side of her face (especial jawline area, marionette line area, nasolabial folds, both temples and lower eyelid region) and the area along the back of both ears on the back head are very uncomfortable. From thumb finger till middle figure of both hands are numb especially after getting up daily. The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention). Both gums are very soreness and distention. Stuffy nose and night sweats in the whole body happen a few times daily after the 2nd dose as well. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
66 2021-03-16 night sweats The evening after patient received vaccine, she started to develop low grade fever and urticarial ra... Read more
The evening after patient received vaccine, she started to develop low grade fever and urticarial rash at the vaccine site. The urticaria improved the following day, as did the fevers. Then 3/5, the fevers started again, several times per day, as high as 102 at home. In association with the fever she has had some mild nausea, x1 non-bloody emesis last night, as well as rigors/night sweats. She went to urgent care and eventually was admitted to the hospital for the following 9 days. During this admission, she continued to have fevers intermittently as high as ~103. She also developed more generalized urticarial rash (worst on trunk), and lab abnormalities including low platelets and elevated liver function tests. She had extensive testing, ultimately determined likely vaccine reaction, started on prednisone 40 daily and improved for discharge to home on 3/17 without fevers x48 hours and with improving labs.
66 2021-03-17 pain in extremity Arm was sore for a day; This 66- year-old female patient contactable consumer (reported for herself)... Read more
Arm was sore for a day; This 66- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 13Feb2021 at 10:00 AM (at the age of 66-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: Thyroid problem. Concomitant medication included: Synthroid 88mcg, Synthroid 75mcg, Ibandronate. On 13Feb2021 at 5:00PM, the patient reported that her arm was sore for a day. The clinical outcome of the event arm sore was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
66 2021-03-17 tingling, tremor, numbness On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had ... Read more
On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had parkinsons disease. The heaviest shaking was of the right arm and hand which was where the vaccine was administered. Made my way to bedroom on my walker to tell hubby I was not feeling well, Took blood pressure which was elevated and my heart felt like it was beating out my chest, Bllod pressure was elevated and so was pulse. Shaking continued and breathing was shallow, Waited 10 minutes and retook vitals, BP and pulse up more, Called 911, Paramedics came and monitored my vitals several times which after 20 minutes started declining, Could not say conclusively if was vaccine related. Elected due to Covid not to be transported to hospital and signed off on declination, Was told by paramedics to call 911 again if symptoms reoccurred and go to hospital, In successive days I still continue to have pin-prick feelings and numbness in my right fingers, More difficult to walk than usual,
66 2021-03-18 pain in extremity, inability to speak I had the second vaccine on February 13 in afternoon. I had a stroke causing expressive aphasia on ... Read more
I had the second vaccine on February 13 in afternoon. I had a stroke causing expressive aphasia on the evening of February 14. I had no side effects from the first vaccine and just soreness in arm of injection after the second vaccine. I realize that the stroke could coincidental but thought I should report it just in case for information in the event others had similar event.
66 2021-03-20 weakness N/v, confusion, headache, chills, weakness
66 2021-03-22 bell's palsy, slurring, facial pain, facial paralysis, weakness Got flu like systems the following day and each day felt weaker with headache and ear and neck pain ... Read more
Got flu like systems the following day and each day felt weaker with headache and ear and neck pain thought flu ignored. Then felt worse went to urgent care tested negative for corona virus. Seen by dr on site.12/12/21. Double ear infection. Home with antibiotics, got worse. Face extreme pain went to ER at hospital due to left side face dropping and speech slurring was diagnosed with double ear infection and Bell Palsy on 3/14/2021.
66 2021-03-24 pain in extremity Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable co... Read more
Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable consumer (patient). A 66 years old female patient (weight: 107.95 kg, height: 165 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 04Mar2021, at 16:50, for COVID-19 immunisation. Relevant medical history included atrial fibrillation from Jan2016 and ongoing and cardiac ablation on an unspecified date, in Feb2020 (she had her 2nd ablation in Feb2020, since then she has had intermittent episodes of atrial fibrillation. She stated prior to the second vaccine she had been in normal sinus rhythm for 8 days). Patient stated that she had a sister who had an arrhythmia problem. The patient previously, on 10Feb2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) in the left arm, at single dose, for COVID-19 immunisation. Patient stated that she had no problem with first dose. The patient received concomitant medications (unspecified). On 04Mar2021, at 21:00, the patient experienced atrial fibrillation and on 04Mar2021 she was tired. On 05Mar2021, she developed pain in the left arm. The patient recovered from pain in arm on 05Mar2021, from tiredness on 07Mar2021, while did not recover from atrial fibrillation. The information on the lot number has been requested.
66 2021-03-24 bell's palsy This is a spontaneous report from a contactable consumer. A 66-year-old female patient received her ... Read more
This is a spontaneous report from a contactable consumer. A 66-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at the age of 66-years-old, via an unspecified route of administration in left arm on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included high blood cholesterol and triglycerides. The patient was allergic to medications, food, or other products (unspecified). She was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. She received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a hospital. On 09Mar2021 at 15:00, the patient presented with Bell's palsy which required a doctor or other healthcare professional office/clinic visit and was treated with BETAMETASONA 5.0 mg. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
66 2021-03-26 weakness high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and se... Read more
high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and severe pain and weakness.
66 2021-03-28 facial paralysis, one side paralysis, slurring Patient presented to the ED on 3/4/2021 with left facial droop, left-sided weakness, and dysarthria ... Read more
Patient presented to the ED on 3/4/2021 with left facial droop, left-sided weakness, and dysarthria that started upon awakening that morning. Patient found to have an ischemic stroke and ultimately admitted to hospice. Patient expired on 3/10/2021.
66 2021-03-28 pain in extremity, weakness, speech disorder feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous... Read more
feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous out of her chest; feels so tired; no appetite, food doesn't taste right; sweating and chills; sweating and chills; feels weak; extremely sick; joints and arms hurt; joints and arms hurt; doesn't feel like walking around/Lethargic; can't hardly even talk to people; Headache; feels like she has been poisoned; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration on Left arm on 09Mar2021 between 15:00 and 16:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient states she took that shot on Tuesday and she is still sick and still doesn't feel good. States that she feels better, but she is coughing and spitting up white mucous started on 10Mar2021. She feels like she has been poisoned in Mar2021. States that she is coughing stuff up out of her chest. States that she took this on Tuesday (09Mar2021) and still feels drugged and tired. She states that it made her extremely sick and she is not taking the second shot. She states she took the shot Tuesday and didn't get sick until three to four hours after, she was down feeling so bad, like an ailment or disease. She states she feels like we gave her the Covid. She states she won't even go to the hospital because can't trust anyone. States that her joints and arms hurt and can't hardly even talk to people on 09Mar2021. States she has fluid in her chest that she didn't have before on 10Mar2021. States that this is the first day she has gotten out of bed. States that she is not taking the second shot. States that she had to sit for fifteen minutes after her shot and she felt fine. Clarified that she couldn't eat, she had sweating and chills for two to three days and she couldn't even get out of bed on 19Mar2021. States she feels better but still feels weak and lethargic on 09Mar2021. States it has improved since yesterday. States that her food doesn't taste right but no appetite on 09Mar2021. States the sweating and chills ended 11Mar2021. She states that she had a headache and it started on 09Mar2021 and it went away 12Mar2021 with treatment of Aspirin. Not sure if she is going to recover. Prior to vaccination, was the patient was not diagnosed with COVID-19. The outcome of events Poisoning; feels drugged, extremely sick was unknown, for Coughing and spitting up white mucous out of her chest was not resolved, for headache it was resolved on 12Mar2021, for feels so tired; no appetite, food doesn't taste right; joints and arms hurt; doesn't feel like walking around; can't hardly even talk to people; feels weak; Lethargic was resolving, for fluid in her chest that she didn't have before was not resolved, for sweating and chills it was resolved on 11Mar2021. Follow-up attempts are completed. No further information is expected.
66 2021-03-28 tingling, weakness peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination;... Read more
peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
66 2021-03-30 weakness I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fev... Read more
I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fever. On Saturday I was better but still weak and that is when cellulitis started in my left leg. On March 7, 2021, I was seen in the ER. I was given a shot and antibiotics and told to return if not better. So on Monday, March 8, I returned to ER and then was admitted to the hospital. I was allowed to go home on Saturday, March 13. Since then I had two sores to develop on my left leg. I had to have wound surgery on them on March 25. I am a lot better but still not completely well.
66 2021-03-30 seizure, inability to speak Jerking movement were to hands when observed during med pass. Tonic clonic movements were assessed ... Read more
Jerking movement were to hands when observed during med pass. Tonic clonic movements were assessed for approximately 2 minutes. Code called and patient sent to ER via 911 No history of Seizures she has ongoing seizures. there is a significant decline in her mental status. She is not speaking. She has to be fed. She is not walking.. She is scheduled to see a neurologist in June 2021.
66 2021-03-31 pain in extremity, bell's palsy Bell's palsy; Sore Arm; This is a spontaneous report from contactable consumers (one is the patient)... Read more
Bell's palsy; Sore Arm; This is a spontaneous report from contactable consumers (one is the patient). A 66-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose, via an unspecified route of administration, administered in Arm Right on 03Mar2021 11:40 am (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. The patient was vaccinated at a hospital. Medical history included Type 2 diabetes mellitus: Diagnosed one year ago; Gastrooesophageal reflux disease (GERD) Diagnosed 2 years ago; Hashimoto's disease Diagnosed 5 or more years ago; High cholesterol and blood pressure abnormal (reported as Blood pressure); all from an unknown date and unknown if ongoing. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks, also no Family Medical History Relevant to the adverse events. Concomitant medications included metformin 500 mg once a day by mouth taken for diabetes (reputed Has been taking that about a year); pravastatin sodium (PRAVACOL) 40 mg once a day by mouth taken for High cholesterol; levothyroxine sodium (SYNTHROID) 50 mcg once daily by mouth taken for an unspecified indication; omeprazole 20 mg once a day by mouth taken for an unspecified indication; and losartan 50 mg once a day by mouth taken for blood pressure; all start and stop date were not reported. It was reported that the patient is calling about the COVID Pfizer vaccine shot. The patient took the first dose of the shot on Wednesday 03Mar2021. The patient now has been diagnosed with Bell's Palsy and she believes that it is from the shot. The patient's speech is impaired because of the bells palsy. The only thing the patient had was a sore right arm on 04Mar2021. Then on 10Mar2021 the left side of her neck started to really hurt and behind her ear, it was severe pain, frequently she would get a jolt of pain on top of the existing pain. The patient had this pain 10Mar2021, 11Mar2021, 12Mar2021, and by Saturday 13Mar2021 her face started to distort, now she couldn't close her eye, her lips were numb, and her speech was interfered. Monday (15Mar2021) morning the patient was seen by her primary care provider and her doctor told her it was Bell's Palsy. Blood was drawn at that time, but the patient doesn't have the results yet. The patient was given prednisone and an anti-viral which after she took them it helped with the pain significantly. The patient's face still has the paralysis on the left side of her face. No other parts of her body were affected other than a sore arm at the site on the right side, which was not a big deal. It was reported that the patient is taking COVID vaccine as she heard she should get it and her husband had the shots and was fine. The patient mentions that her husband had one bad day after the vaccines but he was fine, so she decided to get it. The patient wanted to know, she is going to follow up with her primary care provider on 22Mar2021 but she was scheduled for her second Pfizer shot on 24Mar2021, should she get the second dose. The patient read that 40,0000 people were given the vaccine and 4 people had bell's palsy and because of that they discounted it as a side effect, and the placebo group did not develop this. It was noted that the patient did not required emergency room visit but to the Physician's office (Primary Care Provider). The patient does not have the results of her blood work back yet. The outcome of the event a sore right arm was recovered on 06Mar2021; for the other event was not recovered. The relatedness of drug to reaction(s)/event(s) for the event Bell's palsy was reported to be related.
66 2021-04-01 feeling hot, seizure Had 2 seizures; Had 2 seizures; Tongue hurts; it was an allergic reaction; Patient reported that nex... Read more
Had 2 seizures; Had 2 seizures; Tongue hurts; it was an allergic reaction; Patient reported that next the day her arm was so hot that she could have roasted a weenie over her arm and it was very swollen; Patient reported that next the day her arm was so hot; got shingles again after receiving the vaccination; got shingles again after receiving the vaccination; This is a spontaneous report from a contactable consumer (patient's husband). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6202), via an unspecified route of administration, administered in left arm on 12Mar2021 10:30 (at the age of 66-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a health clinic. The vaccine was not administered at a facility. The patient had no additional administered vaccines. No prior vaccinations (within 4 weeks). Medical history included ongoing seizures from 1982 (began shortly after she had the surgery for her brain aneurysm (in 1982 to 1982). The patient had not had any seizure activity for 20 years before the seizures that occurred on 13Mar2021. Sometimes electrical activity in the brain hits the metal clamp used to treat the brain aneurysm and that triggers the seizures); migraines (suffered from migraines when she was younger but hasn't had one in umpteen years. The patient gets tension headaches like most people but not very often); shingles (patient had shingles three times. Patient's first case of shingles was in the early 1990's and that patient had recurrences in the mid 1990's and the early 2000's. The first incidence was the worst and that the second and third occurrences weren't nearly as bad as the first); blood pressure high; ongoing cholesterol; ongoing headache (tension headaches) and was adopted. Family history included migraines with grandkids, a couple of them had migraines and had MRI's she'd had a sister that was 6 years older than her that had died of a brain aneurysm. Concomitant medications included levetiracetam (KEPPRA) for seizures from an unspecified date (in the late 90's) to an unspecified date then from Mar2021 and ongoing; nadolol for headache from 2001 and ongoing; lovastatin for cholesterol from an unspecified date (been on it for a long time) and ongoing and on a low dose of medication for high blood. The patient had the Pfizer vaccine first shot on Friday (12Mar2021). The husband stated his wife (patient) had a possible side effect to the vaccine shot and was concerned with getting the second dose of Pfizer's COVID vaccine. She had 2 seizures the next morning after the shot (on 13Mar2021) which she hasn't had in 20 years. The patient experienced her first seizure about 11:00 on 13Mar2021. It took the patient about 45 minutes to come out of the first one completely, until she was conscious again. The second seizure occurred about 13:00 on 13Mar2021, about an hour and a half after the patient recovered from the first seizure. fter the second seizure, the fire department was called and she was transported to the Emergency Room. The doctor told the husband that it was up to them if they wanted to receive the second dose. The husband stated, "I know there is something out there that I heard about where you can disqualify yourself from getting the vaccine for medical reasons." Also on 13Mar2021, the patient's tongue hurts in the Emergency Room, no one was willing to give her a new tongue after she bit it. The patient's tongue was what hurt's the most, but that it was slowly healing. The patient seemed to be fine since Saturday. he patient's father was really persistent about them getting the Covid-19 vaccinations. A CT scan and blood work were performed while she was in the Emergency Room on 13Mar2021 and reported that everything was fine. The patient went to the emergency room on 13Mar2021 and physician office on 17Mar2021 as a result of the seizure activity on 13Mar2021. On 17Mar2021, the patient's blood pressure was 130/82 with blood work with result of everything was fine. The patient went to her physician on 17Mar2021 due to concern about getting the second dose of the Covid-19 vaccine. When asked about prior vaccinations within 4 weeks of the Covid-19 vaccine, the patient stated that she didn't want to get the first dose of the Covid-19 vaccine because she's never even had the flu shot. The patient stated that back in 1977 when they first came out with the flu shot, she was unable to receive the vaccine as she was pregnant and she has never gotten the flu. The patient reported that she was unable to get MRIs due to the metal clamp in her. Patient reported that the clamp in her head was metal, not surgical metal, and that she has to be very careful because getting an MRI could kill her. The patient reported that next the day (in Mar2021) her arm was so hot that she could have roasted a weenie over her arm and it was very swollen. The patient reported that she went to urgent care and was told that it was an allergic reaction. The patient also reported that she got shingles again after receiving the vaccination. The husband considered the case as non-serious. The patient recovered from seizure with associated disease recurrence on 13Mar2021; for tongue pain was recovering while for the remaining events was unknown.
66 2021-04-01 inability to speak Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous re... Read more
Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 13Feb2021 14:00 (lot number: EL9264) as single dose at the age of 66 years old, for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, spinal stenosis, arthritis and allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included insulin human zinc suspension (HUMULIN U), metformin, pioglitazone hydrochloride (ACTOS), fish oil, tocopherol (OMEGA 3) and valsartan; all taken for an unspecified indication, start and stop date were not reported. The patient previously took bydureon, codeine and celebrex and experienced drug allergy with these medications. The patient previously received first dose of bnt162b2 on 23Jan2021, at the age of 66 years old for COVID-19 immunization (Product: COVID 19, brand: Pfizer BIONTECH, lot number: EL3247, administration time: 03:00 PM, vaccine location: right arm). The patient did not receive any other vaccines four weeks prior to COVID vaccination. The patient had a stroke with expressive aphasia on 14Feb2021 20:00. The patient was hospitalized due to stroke with expressive aphasia for 5 days. The events resulted in emergency room/department or urgent care and hospitalization. On unspecified dates, the patient underwent lab tests and procedures which included computerised tomogram (CTS), laboratory test (labs), magnetic resonance imaging (MRI), and tPA (plasminogen activator inhibitor); all with unknown results. Other tests include: negative COVID test (nasal swab) on 16Feb2021 and negative COVID test (blood test) on 03Mar2021. The patient had speech therapy as treatment for the events. The patient recovered with sequelae from the events.; Sender's Comments: The reported stroke with expressive aphasia is assessed as unrelated to the administration of vaccine BNT162B2 and can be explained as intercurrent medical condition in this elderly patient with underlying diabetes mellitus, hypertension and other comorbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-04-01 tingling, numbness, burning sensation The only immediate reaction to the vaccine was soreness in my arm. On March 11, I woke at 3:30 AM an... Read more
The only immediate reaction to the vaccine was soreness in my arm. On March 11, I woke at 3:30 AM and had almost total hearing loss in my right ear along with some unsteadiness. I have also experienced unusual neurological symptoms like burning, tingling and numbness in my right foot, leg, hand and face. My second vaccine was delayed because I was taking steroids to help with hearing loss. I had my second shot on March 31 with no side effects to date.
66 2021-04-01 numbness, bell's palsy short of breath; fear and anxiety or from the vaccine; fever blisters; fear and anxiety or from the ... Read more
short of breath; fear and anxiety or from the vaccine; fever blisters; fear and anxiety or from the vaccine; like bells palsy; numbness of the right side of her face from her jaw to her ear and up to her right eye; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9267), via an unspecified route of administration, on 26Feb2021 (received at the age of 66-years-old), at a single dose for COVID-19 immunization. Medical history included cold sores, 2 knee surgeries, and ADD (Attention deficit hyperactivity disorder) from an unspecified date and ongoing (diagnosed at 30-years-old). Concomitant medications included methylphenidate hydrochloride (RITALIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and other regular medication. The patient received first dose of Pfizer BioNTech vaccine and developed numbness of the right side of her face from her jaw to her ear and up to her right eye on 26Feb2021. It felt like she had received a lidocaine injection. Her doctor said this can happen with RNA vaccines, affect the 7th cranial nerve and develop Bell's Palsy. She was prescribed Valacyclovir 1mg and has taken it for 3 days. She wants to know what the other Bell's Palsy cases were like. She wants to know what their treatments were. Her doctor said it was okay to receive her second dose at 8am on 20Mar2021 but she wants to do her due diligence and see if there is a case report or study on these patients that developed this side effect. The patient further explained that she had her first dose on 26Feb2021 and was she was there for the 15 minutes for observation. On her way home, the right side of her mouth and the right side of her nostril were numb like Novocaine that you get at the dentist. She said that the numbness traveled up the right side of her jaw to her ear and then over to her right eye. When she got home, she told her daughter and she said that she thought it was because she volunteered all day and was worn out and anxious (26Feb2021). She said that she slammed water and ate crackers and after about a 1.5 hours she started to feel better. She said that she then she called her physician and the doctor told her that it was flaring the nerve root like bells palsy and that it is a RNA Virus. She said that she was placed on some medication for it, but was wondering if she should get the second dose of the vaccine. She said that the doctor asked her if she had previously had cold sores and she said yes. The caller said that her doctor said that it is exactly what that is. The patient stated that she was also short of breath on an unspecified date, but thought it was from fear and anxiousness. She does not know if it was from fear and anxiety or from the vaccine. She said that the doctor told her to take the medication 3 days before and 3 days after her second dose. She clarified that the doctor put her on Valacyclovir HCl 1Gm tablets 1 a day. She said that she broke out with fever blisters on 02Mar2021. She really did not think anything of it until speaking with friends in the medical field and they told her to follow up with this. She added that the fever blisters are healing and only a tiny bit left. It is at the scab and end of healing. Outcome of numbness of the right side of her face from her jaw to her ear and up to her right eye was recovered on 26Feb2021. Outcome of fever blisters was recovering. Outcome of other events was unknown.
66 2021-04-05 nerve pain This greatly accelerated symptoms from after first shot and sent me to ER next morning where was kep... Read more
This greatly accelerated symptoms from after first shot and sent me to ER next morning where was kept on pain med IV for 4 days and received MRI. Discharged home with pain meds, muscle relaxers, and nerve pain med.
66 2021-04-06 muscle twitching, pain in extremity After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nau... Read more
After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer. Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face. After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included: sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days.
66 2021-04-06 muscle twitching, pain in extremity After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nau... Read more
After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer. Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face. After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included: sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days. Adverse event described in on Continuation Page.
66 2021-04-17 numbness, feeling hot, burning sensation, bell's palsy Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning s... Read more
Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; BP 183/90; This is a spontaneous report from two contactable consumers (one is the patient). A 66-year-old female patient (no pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), in left arm on 09Mar2021 at 13:00 (at the age of 66-years-old) at single dose for COVID-19 immunization. Medical history included known allergies at lemon, lime, green peppers, mushrooms, walnuts, sleep apnea, asthma, obesity, anxiety/antidepressants for 35 years from 1986. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), tiotropium bromide (SPIRIVA), albuterol (salbutamol), duloxetine hydrochloride (CYMBALTA), colecalciferol (D3), ascorbic acid (C), antidepressants. The patient previously took furosemide and theophylline and experienced allergies. The patient experienced numbness on the left side of the face, started 25 minutes after the injection, on 09Mar2021 at 13:30 and resolved fully within 30 hours. ER visit immediately. MRI showed nothing. Blood pressure (BP) 183/90. Left side of face hot, red, and a mild burning sensation on 09Mar2021 at 13:30. Diagnosis bells palsy probably. Follow up visit to the doctor concurred. The events resulted in emergency room/department or urgent care; no treatment was received for the events; no Covid prior vaccination; no Covid tested post vaccination. No other vaccine in four weeks. The patient had recovered from the events on 10Mar2021.
66 2021-04-17 pain in extremity, tingling Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurt... Read more
Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Unable to lift arm, pain makes her catch her breath/ Difficult to take a deep breath; Thought she was having a heart or panic attack; Stress, heart rate, panic; soreness from the shot; Stress, heart rate, panic; Stress, heart rate, panic; Stress, heart rate, panic; Tingling in hands and down the arm; crying; This is a spontaneous report received from contactable consumer (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 66-years-old on 22Mar2021 13:57 (Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included topiramate taken for migraine from 15Mar2021 and ongoing. The patient had her shot last Monday afternoon and had some soreness from the shot on Mar2021. On Tuesday, 23Mar2021, it began getting sore back behind her shoulder blade; it has gotten progressively worse, and now she can barely lift her arm. She does not know if it's a muscle or has to do with the vaccine, or if she pulled a muscle although she has not done anything. It's difficult to take a deep breath, she can't lift her arm, it is sore. It hurts down into her chest and around her breast; also, hurts around on her back where her shoulder blade is. She has tried heat compress, cold compress, and massage the area. It seems like the pain will ease up but then it starts again. She becomes stressed about it and her heart rate starts panicking. She gets tingles down the arm. Thought she was having a heart or panic attack. It has gotten worse as the week has progressed. It was worse on Sunday; even worse on Monday; worse yesterday and she was crying. She has also been stressed at work. Doesn't know whether to go to the doctor or an urgent care, or if she needs to. The patient is 66 years old and says she is in fairly good health. Right now she is unable to lift her arm and has tingles in the hand and down the arm. The pain makes her catch her breath. If this gets much worse she is going to go have it checked out. Again mentions that she has been having stress. It does seem to be a little worse. The patient experienced thought she was having a heart or panic attack on Mar2021, stress, heart rate, panic on Mar2021, soreness from the shot on Mar2021, soreness to left arm, hurts in chest around breast, back, shoulder blade on 23Mar2021, unable to lift arm, pain makes her catch her breath/ difficult to take a deep breath on Mar2021, tingling in hands and down the arm on Mar2021, and crying on Mar2021. The outcome of the event Soreness to left arm, hurts in chest around breast, back, shoulder blade was not recovered while for the rest of the events was unknown. Prior Vaccinations (within 4 weeks) was None. She had an unspecified shot but reiterated no vaccines. No AEs following prior vaccinations.
66 2021-04-17 pain in extremity her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extr... Read more
her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extremely painful; her cubicular lymph node was swollen; the area between her neck and armpit has swelled up more and more; pain in between neck and armpit; pain goes into back; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 2 parenteral (reported as "injection") at the age of 66-years-old on 19Mar2021 (Batch/Lot number was not reported) as single dose in Arm Left for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2), dose 1 on an unspecified date for COVID-19 immunization. The patient received the first vaccine with no problem. She received the second vaccine on Friday 19Mar2021 and the next day, 20Mar2021 it felt like her cubicular lymph node was swollen. Every day since then, the area between her neck and armpit has swelled up more and more. Her pain is worse constantly and she can hardly use the opposite arm and even to touch the skin is extremely painful. This is on the opposite side from where she received the shot. The event "area between neck and armpit swelled up" started 20Mar2021 and is ongoing. It increases constantly and it is almost disabling it is in between medically significant and disabling. It has worsened. The event "pain in between neck and armpit" started the past Friday (Mar2021) and is ongoing. It is medically significant but almost disabling as she cannot use her right arm. This has worsened. The event "pain goes into back" started 2 days ago and is ongoing. This is medically significant and has worsened. Treatment was received for the events. The doctor gave her Toradol injection intramuscular and it did not effect anything and she has also taken Tramadol and Flexeril, a muscle relaxer, which did not effect anything. Her doctor has never seen anything like the symptoms she is experiencing. She had an X-ray done but she does not have the results yet as it was done yesterday (29Mar2021). The outcome of the events "her cubicular lymph node was swollen" and "even to touch the skin is extremely painful" was unknown while for the rest of the events was not recovered. Relatedness to COVID 19 vaccine: area between neck and armpit swelled up, pain in between neck and armpit, pain goes into back - Related. Information on the batch/lot number was requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-04-17 seizure seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is ... Read more
seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is a spontaneous report received from a contactable healthcare professional (patient herself). A 66 -year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EN6208; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunisation. She provided a brief history from 2017. She was walking her dog and she fell and suffered a concussion, she had a seizure, then she developed bipolar disorder. She's been taking sodium valproate (DEPAKOTE) for her seizures since 2017. She reports she's very active. She's not an old lady. She can run circles around some 22 year old's. In September of 2017, she had a concussion and had seizures. She's been on sodium valproate (DEPAKOTE) since that time. She's not mentally ill, the concussion she got in 2017 caused her brain to turn bipolar. It's hard for people to understand that. Sodium valproate (DEPAKOTE) was 500mg. She takes 1 tablet in the morning and 2 tablets at night because it can make you sleepy. She reports she was recently hospitalized in Feb2021 for atrial fibrillation with rapid ventricular rate (RVR). Her heartrate was 181 beats per minute, her blood pressure was dropping, she tested positive for rhinovirus and the doctor thinks the atrial fibrillation with RVR was caused from the rhinovirus. She was allergic to bee venom and carries an EPI PEN. Medical history also included ongoing high blood pressure from an unspecified date (controlled with medication). Concomitant medications included ongoing metoprolol tartrate (LOPRESSOR) taken for blood pressure; ongoing lisinopril; ongoing valproate semisodium (DEPAKOTE) taken for seizure from 2017; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for blood pressure; paracetamol (TYLENOL) from an unspecified date in 2021. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021). The patient did not receive any recent vaccines for any other conditions or any recent vaccines for any other conditions prior to the event being reported; or any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient reported that with the second Covid 19 vaccine she had two seizures on 27Mar2021. The seizures were back to back. The seizures resolved within 2 minutes. She had fatigue from an unspecified date, sore muscles and a wrap around headache on 26Mar2021. The wrap around headache felt like she was going to have a stroke even though her blood pressure was fine. She monitored her blood pressure at her home. She feels it's weird that they publish that the second Covid 19 vaccine is going to be worse. She thought she'd have muscle soreness and fatigue but not seizures. She looked it up and the wrap around headache and seizure are the rarest things that can happen after receiving the Covid 19 vaccine. She stayed in bed from Friday afternoon after she received the second Covid 19 vaccine on 26Mar2021 and started to feel better Sunday afternoon, 28Mar2021. Her blood pressure and pulse were both fine with her wrap around headache. She had fatigue with both Covid 19 vaccines. She also developed hives, which she still has. She has a rash from her head to her toes. It looked like she rolled around in an ant bed. The hives were clearing up. She was using an anti-itch cream. The hives and the rash started midday on Saturday, 27Mar2021. She only has around 5 hives now on her chest. She hasn't taken Benadryl. She doesn't like to take it. Her doctor didn't want her to open the hives and cause impetigo. She never had any soreness in her arm. She doesn't think the headache was serious because she had a blood pressure cuff at home. She just knew the hives and the rash were a reaction to the Covid 19 vaccine. She didn't go to the hospital for her seizures. She was not seen in the Emergency Department, hospitalized, or admitted to an Intensive Care Unit. She tries to do holistic medicines and treatments. She doesn't run to the hospital every time something happens. She tries to stay out of the hospital. She's fine now and she loves Pfizer. If she can get a medicine she needs that Pfizer makes she tries to get it. She tries to see every side of things. Outcome of seizures was recovered on 27Mar2021 and sore muscles was recovered on 28Mar2021; of remaining events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and seizure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
66 2021-04-24 pain in extremity swells right under her finger; pain in the center of the palms of her hands and bottom of her feet/ ... Read more
swells right under her finger; pain in the center of the palms of her hands and bottom of her feet/ achy pain; She couldn't straighten it out or bend it all the way down, it was like it was locked; joint went stiff and the pain; joint went stiff and the pain; Center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like; Center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via an unspecified route of administration at left upper arm 10Mar2021 at 12:30 (66-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included thyroid, and "had stem cells put in her hip". Concomitant medications included ongoing thyroid (ARMOUR THYROID) for thyroid. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) via an unspecified route of administration at left upper arm 17Feb2021 at 14:00 (65-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient previously received the second dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for shingles and felt like we were getting the flu and the next morning was fine. Patient states she had stem cells put in her hip and was (medical office name) for an x-ray to see how it's doing. She showed a nurse practitioner her hand and nurse practitioner said patient needs to report that. Patient states it swells right under her finger, swelling under her middle and ring finger. The joint went stiff and the pain. She can't bend her fingers, it is mostly her ring finger. She couldn't straighten it out or bend it all the way down, it was like it was locked. Following her second vaccine dose she has had pain in the center of the palms of her hands and bottom of her feet. The pain is inconsistent as it comes and goes. The feet pain come and go not bad like the hands. The middle of the palm pain comes and goes and the joint on 1 finger never did get better, it is worse at night and a teeny bit better in the morning. She felt pain in 1 of her feet for a moment yesterday and not continuous like her hand. The left hand is not swelling, the center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like, it is an achy pain. States she kept telling her husband she has pain in the center of her hands and on the bottoms of her feet and feels like she is about to have a break out and didn't. Patient states it has been a month since she had the 2nd vaccine. States the symptoms all started within 24 hours of the 2nd vaccine. On 07Apr2021, nurse practitioner put a lubricant injection (name unknown) into her hand where the swelling was. Patient was told it was a lubricant that might help, and it has helped some. It is moving a little better today after the injection but she still has pain. Adverse events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the event "swells right under her finger" and included lubricant injection. The outcome of swells right under her finger, joint stiffness, and joint lock was recovering; other events were not recovered. No follow-up attempts are needed. No further information is expected.
66 2021-04-26 pain in extremity nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels li... Read more
nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Constipated; Doesn't sleep through the night; Headache lasted for days and days; No appetite, lost 6 pounds in a week; No appetite, lost 6 pounds in a week; Tired; Diarrhea; Nausea; felt like Dumping Syndrome; Stiff neck, like an iron claw; Anxiety reared up; Blacked out; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 17Mar2021 at 11:30 AM (at the age of 66 years old) (Lot Number: EN6205, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included ongoing anxiety (40 years or more), ongoing depression (46 years ago, at the age of 20), ongoing acid reflux (maybe 25 years), ongoing GERD (maybe 25 years), ongoing Barrett's esophagus (for 12 years), mild to moderate COPD since 2011, gastric bypass (a year and a half ago), and lost 120 pounds. Concomitant medications included bupropion for anxiety depression and omeprazole for acid reflux, both ongoing. The patient previously received flu and tetanus on unspecified dates for immunization and both experienced hard red welt on arm (welt was hard and lasted for 5-7 days). The patient reported no side effects for 12 hours, but a little soreness at injection site on 17Mar2021 at 20:00 (8:00 PM). Her arm wasn't heavy, but she had an awareness of the soreness. She has had life-long anxiety and depression. Several weeks ago (on 26Mar2021), her anxiety reared up, and it could have been due to a family situation. On the 9th day after the first shot, she was having a therapy appointment on the phone and talking about her anxiety, and she got a stiff neck, like an iron claw (26Mar2021 at 10:00 am). It lasted for a couple of 5 minutes and she laid down on the couch then on the floor. Her therapist said to call 911. Emergency medical technicians came to her house and they said all of her numbers looked good. She went to the hospital, and was in the emergency room for several hours, but she only remembers one hour of it. She also had diarrhea and nausea on 26Mar2021 at 11:30, and it felt like Dumping Syndrome, that one can have from a gastric bypass. She was only aware for one hour at that point and blacked out (on 26Mar2021). With regards to nausea, she mostly saw bile in the bag, all she had that day was a protein drink. She was back home and the next day, she did not remember how she got home. She hasn't had blackouts anymore but feels it may be from heightened anxiety. On 27Mar2021 at 09:00, she had no appetite, lost 6 pounds in a week, and was tired. She had headache lasted for days and days on 29Mar2021 at 09:00 AM. She is slowly improving but she still doesn't sleep through the night on 29Mar2021 at 16:00. It was like a feeling like she was resetting her surgery, like she didn't care about eating. The also experienced back pain, butt and legs hurt, feels like sciatica on 31Mar2021 at 16:00 and was constipated. She is using a stool softener and is back in her routine. She called her primary doctor and could not tell her what happened, and she went in a loop trying to get information and authorizations for her to make a determination of what had happened. Her doctor felt like she should have an MRI. Her heart and all of her numbers looked good, as the emergency medical technicians said. Her primary doctor recommended her to get the second shot. She had cancelled the second shot for this week, and she has rescheduled it for another date. She was afraid that she will black out again, after the next vaccine, and is not sure if that is how her anxiety manifested. The main reasons she is calling is that she had no concerns of side effects prior to the vaccine, and a couple of her neighbors said they had read about side effects of the vaccine, but she was not worried. When the patient started to read about side effects of the vaccine, she understood that on the 10th day, the vaccine starts to be in a person's system and that maybe is why she didn't have initial side effects, but then she had side effects several days later because the vaccine was in her body. By day 10, the vaccine is in effect in the body and she is nervous. Her second vaccine is scheduled on 26Apr2021. The patient would like to know if there is any information on people that have had a gastric bypass. The patient has no prior vaccinations within 4 weeks. The events resulted in emergency room visit (except nervous). The patient recovered from soreness at injection site on 18Mar2021; recovered from diarrhea, nausea, felt like Dumping Syndrome on 26Mar2021; recovered from stiff neck on 26Mar2021 at 10:05am; recovered from constipation on 02Apr2021; and recovered from no appetite and lost 6 pounds on unspecified dates. The patient also recovered from headache with sequelae on unspecified date; and recovered from blacked out on 27Mar2021 with sequelae. The patient had not yet recovered from anxiety reared up; tired; doesn't sleep through the night; back pain, butt and legs hurt, feels like sciatica. No follow-up attempts are possible. No further information is expected.
67 2021-01-01 pain in extremity Sore arm ??
67 2021-01-03 weakness On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, e... Read more
On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, etc.). Noticed some circumoral cyanosis around my lips after arriving home. Had a fine afternoon (sleeping following vaccine and 16 hr. shift). Had dinner and usual evening. Upon going to bed about 11pm, I experienced chills for several hours, and shortness of breath. Very weak. Called 911 about 3 am - went to hospital ER - O2 sat. 90% enroute. Vital signs stable in hospital ER. Had neg. CXR, EKG, and labs. Also had slight cough and slight bronchial congestion. Received some IV fluids in ER. Left ER at 7am. Went home and slept all day, slight nausea in am. Awoke at 7pm - had good breakfast for dinner. Fine evening and night. Off the next day from work - usual day. It was like having Covid all over again (positive X2 in April - out of work for 5 weeks). Although the symptoms began about 12 hrs. following the injection and subsided about 24 hrs. later). My colleagues (work as a nurse in long term care - rehab) who had Covid in the past have experienced similar symptoms following the vaccine, even though we had Covid back in the spring. Dreading vaccine number 2 on Jan. 19th - hopefully I will be ok.
67 2021-01-04 burning sensation burning sensation in my flank area of left back, extending from the spine. I couldn't wear clothing... Read more
burning sensation in my flank area of left back, extending from the spine. I couldn't wear clothing because it was unbearable, It lasted until Monday. I texted my friend that is a Dr and he recommended to wait it out. I still get brief sensations but I am more or less over it
67 2021-01-04 cold extremities, flushing flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a sponta... Read more
flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a spontaneous report from a contactable physician (patient herself). A 67-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 24Dec2020 13:15 in left arm at single dose for covid-19 immunization. Medical history included none. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included methylphenidate hydrochloride (RITALIN) and one-a-day ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS), both from Dec2020 for an unspecified indication. Immediately after vaccine, patient experienced flushing, then lightheadedness, and waves of flushing and chills every minute for several hours; tongue numbness, dry mouth, cold hands and feet; no rash, no breathing difficulty - normal vital signs on 24Dec2020 13:30. Patient received iv diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) and iv hydration after symptoms were not improving 3 hours later - several hours after this treatment, the flushing and chills continued, as did numbness of tongue and dry mouth. Symptoms were still present 22 hours after injection-waves of flushing and chills. The events were reported as non-serious and the events resulted in Emergency room/department or urgent care. Outcome of events were not recovered.
67 2021-01-05 pain in extremity Headache Fatigue; Arm soreness
67 2021-01-05 tingling I woke up with tingling in my right hand and arm, my right side, and down my right leg. I went to th... Read more
I woke up with tingling in my right hand and arm, my right side, and down my right leg. I went to the ER at Hospital, and was confirmed to have had a stroke in my left thalmus.
67 2021-01-06 tingling UrticariaPruritus Tingling of upper lip and under eyes Narrative: 12:45 stated upper lip felt fingly... Read more
UrticariaPruritus Tingling of upper lip and under eyes Narrative: 12:45 stated upper lip felt fingly and under eyes; VS 73, r 16, BP 1589/90, sat 98%. ambulated to MD office Evaluated by Dr. Benadryl ordered (25mg PO x 1 dose) and given at 1305). Ambulated back to personal office, called friend to pick up after work. 1330, 72, 16, 96%, 135/82, denies worsening of symptoms, no rash or hives noted. No symptoms of difficulty breathing, swelling of face or tongue, increased heart rate, rash or dizziness or head ache. Assessment and follow up by M.D.
67 2021-01-09 pain in extremity Minor pain in arm starting about 10 hours after vaccination and ending by 3rd day.
67 2021-01-10 tremor 5 minutes after vaccination, patient reports heart pain, chest palpitations, shortness of breath, an... Read more
5 minutes after vaccination, patient reports heart pain, chest palpitations, shortness of breath, and shakes that patient attributes to anxiety from possible reaction.
67 2021-01-11 cold sweat Received vaccine on 1/4. Woke on 1/5 with cold sweats and painful diarrhea. Called Covi hotline. Ins... Read more
Received vaccine on 1/4. Woke on 1/5 with cold sweats and painful diarrhea. Called Covi hotline. Instructed to stay home form work until symptoms improved.
67 2021-01-12 feeling cold Developed fatigue, chills, body aches
67 2021-01-12 unresponsive to stimuli The lady lost consciousness, not responsive, pale, dizzy, was evaluated on site by fire rescue. Tra... Read more
The lady lost consciousness, not responsive, pale, dizzy, was evaluated on site by fire rescue. Transferred to hospital by ambulance at 9:11 am and the lady and husband refused to go to the hospital. Released home at 9:27 am.
67 2021-01-12 pain in extremity arm is sore; Fatigue; eyes are still heavy; a metallic taste in her mouth; sleepy/eyes are still hea... Read more
arm is sore; Fatigue; eyes are still heavy; a metallic taste in her mouth; sleepy/eyes are still heavy/she is yawning a lot more; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 06Jan2021 at single dose in her left arm for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient had no investigation assessment. It was reported that it had been 24 hours, she received her first bnt162b2 (reported as Pfizer COVID vaccine), yesterday (on 06Jan2021), and she was wondering, her arm was sore on 07Jan2021, which she thought was normal and fatigue on 06Jan2021, she got right away, she didn't know if that was normal, but she got a metallic taste in her mouth on 06Jan2021. It felt like a metallic taste when she swallows, a little metallic taste, yesterday (on 06Jan2021) was more than today, it was after the vaccine, about 7 hours after. She thought in her head, like the aluminum chewing gum, when kids chew it, it had a metallic taste, like the (company name withheld) wrapper she used to chew on it. Provides she was shrinking. Provide she was wearing stretch pants when providing weight. She Googled and didn't see the metallic taste, the only thing she saw with metallic taste is if you have the actual virus, she didn't have it, she was fine. Maybe it was all in her head. Arm was sore not right away, it built up, like when you stretch like with the flu shot, she lifted and it's sore, and she felt sleepy. It was like with the flu shot, it took a few days to go away. Last night on 06Jan2021, she was very sleepy, she was kind of sleepy, but it could be watching the Capitol and insanity, but she was yawning a lot more, her eyes felt heavy, she was ok, she had an appetite and is fine, she would drink (company name withheld) now. Thought she was peaking with it, she would go to sleep early today (07Jan2021), her eyes were still heavy, she wanted to close them and took a nap, but couldn't. It was like her saliva has a metallic taste in her mouth, it may be in her head, she googled to see side effects and when they start, it may be going soon, who knows, she was just wondering. The taste was worse yesterday (06Jan2021), and it wasn't IV or anything like that, the patient wanted to know how can that be. She had to go back on the 27th for her second dose. She had been tested and retested on an unspecified date, and it was offered for those 65 and over, and she was lucky to get an appointment. The outcome of the event metallic taste was recovering; the events fatigue and eyes heavy was not recovered; the outcome of the rest events was unknown.
67 2021-01-13 feeling hot Left hand in thumb area and Left wrist patient reported a twinge feeling and was very warm. Blood ... Read more
Left hand in thumb area and Left wrist patient reported a twinge feeling and was very warm. Blood pressure was 126/80, pulse ox 95 and pulse 73. Gave patient H2O and patient sat another 15 minutes. Left with no more symptoms and vital signs were 120/78, pulse ox 94 and pulse 75
67 2021-01-13 seizure Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. ... Read more
Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. Resident was found in the floor of her room. She had fallen and was having a seizure, temperature was 99.7F and Oxygen saturation was 82%.
67 2021-01-13 cold extremities, numbness, feeling cold Within 15 minutes after the shot left upper arms and forearm felt cold; followed by neck (left side)... Read more
Within 15 minutes after the shot left upper arms and forearm felt cold; followed by neck (left side) feeling cold; patient began to have a headache and left lower jaw felt numb. This was also experienced on lip & cheek. Patient was coherent. not dizzy. Patient was being checked on and stayed to about 2:40 PM when patient could feel the numbness subsiding. At 5:40 PM. Patient has a little numbness and a headache on left side of the head. Patient shot was administered on left arm.
67 2021-01-14 discomfort INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SIT... Read more
INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SITE RADIATING DOWN THE ARM TO HAND AND INTO THE L SHOULDER (I BELIEVE IT WAS GIVEN TOO CLOSE TO THE NERVE: THIS RXN R/T VACCINE DELIVERY TECHNIQUE; RXN TO VACCINE ITSELF: 32 HOURS AFTER ADMIN, CHILLS, SEVERE ARTHRALGIAS THAT LASTED 12 HOURS AS WELL AS SUSTAINED HEADACHE AND SACRUM ACHE FOR 4 DAYS
67 2021-01-14 flushing, hot flush Pt verbalized feeling flush on the face (red cheeks), she was evaluated by paramedics and released h... Read more
Pt verbalized feeling flush on the face (red cheeks), she was evaluated by paramedics and released home at 1:20 pm feeling better.
67 2021-01-14 pain in extremity received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to hersel... Read more
received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to herself out of bed, needed to wake husband for assistance due to employee being unable to use Right arm. Developed headache, chills, sweats, joint pain Stated "it felt like I was hit by a bus" felt like I got beat up. Wednesday Headache was gone, R arm swollen, lymph nodes at axilla and R neck large as grapes, painful. No appetite, effort to move .Arm was swollen and reddened at injection site.
67 2021-01-16 pain in extremity sore arm redness at the site chills and fever-101.3 fatigue
67 2021-01-17 numbness States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb a... Read more
States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb and hands felt weak. Did not seek any medical attention. Entirely resolved day of reporting this (1/18/21).
67 2021-01-18 feeling hot After receiving the vaccine, client verbalized she feels hot and sweaty. Client was evaluated by Fi... Read more
After receiving the vaccine, client verbalized she feels hot and sweaty. Client was evaluated by Fire Rescue on site. Client's symptoms resolved and released to go home per Fire Rescue at 10:28 am.
67 2021-01-18 pain in extremity I got Covid from my husband which he tested positive on 12-26-2020. On 12-26-2020 I tested positiv... Read more
I got Covid from my husband which he tested positive on 12-26-2020. On 12-26-2020 I tested positive for Covid. I developed headaches, cough, congestion along with a sinus infection and had left arm soreness. I also received my 2nd dose injection on 01-06-2021 at 9:30am.
67 2021-01-19 flushing, tremor, feeling hot Flush/warm face followed by dry mouth/tongue and then shakes/jitters. Flush went away but dry mouth/... Read more
Flush/warm face followed by dry mouth/tongue and then shakes/jitters. Flush went away but dry mouth/tongue and shakes/jitters continued. The monitoring staff kept me under observation for 1.5 hours, and then I left after symptoms mostly subsided. I've never had any adverse reaction to a vaccine or other medication ... although I tend to be medication sensitive so I avoid it if possible. My only allergies are seasonal/pollen (outdoor) and some indoor (mold, etc.) What was my reaction? Can I take the 2nd dose or not?
67 2021-01-19 numbness, tingling, pain in extremity Neurological symptoms. Stabbing pain in left foot, numbness and tingling in both legs and arms. Pa... Read more
Neurological symptoms. Stabbing pain in left foot, numbness and tingling in both legs and arms. Pain woke me up in the middle of the night. Took Gabapentine 300 mg. , two doses. Pain resolved the next day.
67 2021-01-19 flushing, tingling Pt presented to COVID vaccine clinic today and developed a mild reaction after receiving the second ... Read more
Pt presented to COVID vaccine clinic today and developed a mild reaction after receiving the second Pfizer vaccination. Pt reported a blister like rash on her chest after receiving the first dose. Hx of hives with adhesives and latex, occasional rash with tylenol. Pt reported a flushing sensation and swollen lymph nodes in neck 30 minutes after administration. Pt reported tingling in her hands shortly after. BP: 135/73 HR: 72 O2: 100% Pt denied SOB, swelling of face/tongue/throat, difficulty swallowing, nausea, itchiness, dizziness. No visible swelling. Paged Allergy (Itchy). Advised to give Zyrtec 10 mg and observe to see if there is any improvement. Symptoms improved 15 minutes after administration of Zyrtec 10 mg. Pt sent home and advised to continue to take antihistamines as needed
67 2021-01-19 tingling aprox 15 minutes after receiving the vaccine, client started c/o headache and tingling from head to ... Read more
aprox 15 minutes after receiving the vaccine, client started c/o headache and tingling from head to hands, denied difficulty breathing. 11:25 client denies any tingling at this time. She was released to her husband and told to monitor her symptoms.
67 2021-01-20 numbness Pt reported left arm numbness & light-headedness. AAOx3. EMTs arrived and offered a snack and a dri... Read more
Pt reported left arm numbness & light-headedness. AAOx3. EMTs arrived and offered a snack and a drink. Released after brief monitoring.
67 2021-01-20 numbness Pt reported left arm numbness & light-headedness. AAOx3. Rapid response arrived and offered a snack ... Read more
Pt reported left arm numbness & light-headedness. AAOx3. Rapid response arrived and offered a snack and a drink. Released after brief monitoring.
67 2021-01-20 unresponsive to stimuli, muscle twitching She began to have twitching on the day of vaccine 1/12/2021 but does have a history of seizures seco... Read more
She began to have twitching on the day of vaccine 1/12/2021 but does have a history of seizures secondary to cancer, low grade temp of 99.4 for which she was given tylenol. After the tylenol her fever broke but the lip twitch persisted and her body began to twitch intermittently. She continued to have the twitching throughout the evening and then became unresponsive. She was sent out EMS to our local hospital. She was admitted and returned from the hosptial on 1/19/2021 and state she feels fine. New Diagnosis of Metabolic Encephalopathy
67 2021-01-21 pain in extremity, weakness 1/7 6:30PM TO 1/8 1PM: ARM PAIN FLU-LIKE SYMPTOMS CHILLS, HEADACHE, BODY ACHES WEAKNESS TOOK TYLENOL
67 2021-01-21 weakness, feeling hot, flushing 12/27 vaccination 12/30 felt good all day. Ate supper. Sat down to watch news, read. At about 8 o'c... Read more
12/27 vaccination 12/30 felt good all day. Ate supper. Sat down to watch news, read. At about 8 o'clock, i had almost collapsed out of the chair. I was extremely flushed, never felt so hot in my life, thought i was going to pass out. I got to the floor, I was extremely weak. I had a hard time getting up. I made the call to my dr answering service. I did get up and get some water. I took my BP evening meds, it was in the 200's/90-100. When dr called me, i relayed info. Words not slurred, no paralysis. Extreme sensation of being flushed. O2 stats were good; 96-100%. I went to local emergency in my neighborhood. 'uncontrolled pain' BP 192-100
67 2021-01-21 feeling hot 6PM FELT HOT, DEVELOPED CHILLS. TEMP OF 100.6--TOOK 2 TYLENOL TABS. 5: 30a HAD HEADACHE AND DIZZINES... Read more
6PM FELT HOT, DEVELOPED CHILLS. TEMP OF 100.6--TOOK 2 TYLENOL TABS. 5: 30a HAD HEADACHE AND DIZZINESS-STILL HAD CHILLS. TYLENOL 2 TABS, WATER AND GATORADE.
67 2021-01-21 burning sensation, pain in extremity General malaise with burning sensation inside the body, no fever registered; inflammation of right a... Read more
General malaise with burning sensation inside the body, no fever registered; inflammation of right arm and hand/wrist, migratory joints pains, muscle pain, stabbing pains sudden, neuralgic pain in the extremities. Pain was so severe that cause limitation for walking around the house. The last event on the 7th day was inflammation of the right foot and ankle with severe pain with no history of sprain or trauma.
67 2021-01-24 pain in extremity, weakness The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .aft... Read more
The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .after the 3 days i went back to normal on Jan 22 i wake up with pain in left arm i thought it was due to my neck issue Sunday the 24 th noticed that my Arm is swollen and red check with a primary care provider and been told that i hv cellulitis that he thinks it is from the injection . The Physician prescribed immediately doxycycline 100 mg twice a day for 10 days .. on the 25 i informed my care provider . I started the Antibiotics Jan 24th at 8:00 pm.
67 2021-01-24 pain in extremity yesterday I got a really, really bad headache, that I still have; sore arm; This is a spontaneous re... Read more
yesterday I got a really, really bad headache, that I still have; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration in the left arm on 06Jan2021 at a single dose for COVID-19 immunization. Medical history included lung condition, sarcoidosis, immune system problems, ongoing headache and migraines. Concomitant medication included topiramate for headache and to ward off migraines. States it is in a white bottle, but a pharmacy bottle from (Pharmacy name). She provides discard after 18May2021. Now clarifies it is Topiramate, the generic, 50 mg, it helps ward off migraines. She sees a neurologist for this, not by her internist, she sees the internist who prescribes it twice a year, actually, it is so her headaches don't turn into a migraine, this is just a worse headache, she doesn't know what this is from, hopefully it will just get better. The patient previously took codeine and experienced drug allergy. It was reported that she received the first dose of the vaccine on Wednesday, 06Jan2021. Patient reported that "she's a headache person and gets them all the time." Per the reporter, late yesterday on 10Jan2021, she got a really, really bad headache, that she still have. Could this be vaccine related this far out? The only thing she got right after the vaccine was a sore arm. It's not debilitating (the headache). She is going through a few stressful situations with a friend and her son going through a divorce. She do have a lung condition that's now in remission. She was being followed by a pulmonologist and she is taking something. She is allergic to codeine. She will continue to take Tylenol and will continue to just deal with it." She said that her husband believes the current headache is related to stress. It was further reported that she got the vaccine last Wednesday, on 06Jan2021, she is a headache person, she gets headaches all the time, and takes Topamax (later clarified as the generic, topiramate) on a daily basis, but yesterday on 10Jan2021, late afternoon, she got a really really bad headache, that is still there today, but she didn't get it right after the vaccine, she wondered is that related, or would she have gotten it right away, the headache? States it is not horrible bad, it's just a bad headache, she still wants the second vaccine, and she doesn't want this to interfere, she has a lot of medical conditions, this is why she was afraid to call. Her husband doesn't think this has to do with the vaccine, but she felt like, let her just call. She still has it (headache), she is a headache person, it got better then she got it again, and it also could be stress related, she has been dealing with a few things: she has a friend giving stress, her son is going through a divorce. But she did not get it right after the vaccine, the vaccine was early Wednesday, which is why her husband doesn't think it has to so with anything. Also, she has a lung problem, and thank god she is in remission, she has sarcoidosis, and she has immune system problems, so she has medical reasons. But the issues most important are the lung. She is having blood work done tomorrow, so it has nothing to do with it. States this is good to tell about the stress: she has a friend, a toxic friend, she lives in (State Name), the friend lives in (City Name), and she is a negative person, and she is ending a longstanding friendship, which is not like her, so that is weighing on her mind, and that is, could be, adding to it, and even hurts a little, that's stress, but since she had the vaccine, she thought to call and see. She can definitely get the second dose, right? This report doesn't affect her getting the second dose? After reviewing the call recording, there is no mention of the friend getting the vaccine. The reporter said her friend is giving her stress, and in regards to the statement "weighing on her mind, and that is, could be, adding to it, and even hurts a little, that's stress, but since she had the vaccine", the reporter was referring to herself. Additionally, the statement "But she did not get it right after the vaccine, the vaccine was early Wednesday" the reporter was also referring to herself. The outcome of the event 'headache' was not recovered while unknown for the other event.
67 2021-01-27 numbness, weakness, tingling Spoke with Patient regardingside effects following her #1 Covid Vaccine on 1/15/21. She stated that ... Read more
Spoke with Patient regardingside effects following her #1 Covid Vaccine on 1/15/21. She stated that about 12 hours later developed extreme fatigue, all over weakness, headache, she also c/o intermittent numbness & tingling in bilateral lower extremities (mid-calf to toes) she states that she also has Resless Leg Syndrrome that is untreated. Has been in contact with her PCP. Encouraged her to "Self-Report" to the Vaccine's web-site listed in the Vaccine handout. Encouraged her to call back if she has further concerns or questions.
67 2021-01-28 numbness, tingling 1/28/2021 02:38:41 PM > 1410: Patient c/o numbness and tingling to L arm approximately 7 minutes aft... Read more
1/28/2021 02:38:41 PM > 1410: Patient c/o numbness and tingling to L arm approximately 7 minutes after receiving injection with no other complaints, nurse added additional 10 minutes to observation time. 1430: Patient states numbness is getting better, nurse encouraged patient to go to nearest ER if problem persisted. RN 1/29/2021 08:55:46 AM > contacted patient to f/u, message left
67 2021-01-28 pain in extremity Almost immediately after taking the vaccine for covid19, I felt extreme dizziness (vertigo). The nu... Read more
Almost immediately after taking the vaccine for covid19, I felt extreme dizziness (vertigo). The nurse had me drink some water and eat some nuts. I had drunk some glucerna that morning for breakfast with my medication. The RN had me wait for about an hour. I then called my primary care doctor who told me to go home and rest. He said that I did not need to go see him or go to a clinic or Emergency Room unless I felt worse. (I have progressively felt better). I left his number and contact information under the contact information above. However, I had received the shot from the Hospital site. I am providing this as you were a little vague in your question about contact address. Anyway, my husband took my temperature about 6 pm. I had a temperature of about 93.8. I normally have a temperature of 98.6 F. He used a digital thermometer. However, I did not feel as if I had asthma. I did have a slight headache then and my arm was a little bit sore. Today (the 29th) my temperature is about normal. I do not have any breathing problems, but my arm is a little bit sore where I got the shot. I still have a slight headache, but it's not too bad. I don't need to take medication for it. There is no redness at the site of the injection. I should mention that one of the RN's did look at my fingernails and the color was normal which I assume means no problems with oxygen levels. I am only reporting this because of the extreme dizziness! I felt a lot better after about an hour after taking the shot, drinking the bottle of unflavored (still) water and eating the nuts. My A1C is back to normal today. (and remember I am not currently needing or taking any form of insulin but my doctor has my blood checked regularly and has for many years). I am only putting no on the item number 20 below because I still have a slight headache and a little bit of soreness in the injection site. Today the site of the injection is not red either.
67 2021-01-28 tenderness, pain in extremity Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right a... Read more
Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right armpit, started 24 hrs post vaccine, still occurring; no treatment for anything
67 2021-01-28 pain in extremity, discomfort Night 3 of vaccine woke in am with right mild thigh gnawing, a sensation never experienced before.... Read more
Night 3 of vaccine woke in am with right mild thigh gnawing, a sensation never experienced before. Duration 1-2 hours. Night 4 woke 2 am with more intense discomfort left knee, again not like anything experienced before but did not require Tylenol. It was gnawing and annoying, Night 5 woke around 4 am with left lower leg/ side of foot mild ache which lasted a few hours. Stretching, changing positions had no effect on any of three nights. Day after vaccine while exercising I perspired more than usual and was tired. Did not concern me in any way and would not have reported unless had above symptoms. Question- Do any of the above symptoms indicate I should not get dose 2? Thank you
67 2021-01-28 flushing, feeling hot Patient developed a full body flushing/warmth sensation. Sent to the ED.
67 2021-01-28 tingling Pt developed pins/needles sensation in right hand 10 minutes post-vaccination. wrist to finger tips... Read more
Pt developed pins/needles sensation in right hand 10 minutes post-vaccination. wrist to finger tips. Denies pain, numbness. Assessed by RN (denies airways, breathing, swelling problems). Denies hives
67 2021-01-28 muscle spasms Strong muscle cramps/spasms in stomach and upper abdomen, primarily on left side. Mild nausea
67 2021-01-28 pain in extremity, tremor shaking chills body aches headache fatigue red sore arm
67 2021-01-28 burning sensation shingles pain flair up. right mid riff and left arm, and left neck, cheek, and foot. A burning pain ... Read more
shingles pain flair up. right mid riff and left arm, and left neck, cheek, and foot. A burning pain and dizziness. the pain is very intense causing me to lay down and close my eyes. This has happened everyday for two weeks now. everyday is the same and has not gotten better.
67 2021-01-29 tingling No problem with injection site. Developed what appears to be a rash (hives?) on my right side at my... Read more
No problem with injection site. Developed what appears to be a rash (hives?) on my right side at my waistline. Noticed two spots and at first thought it was bug bites. Since Wednesday, several more spots have appeared in same area around waist from navel area around to back. Spots are not large or itchy but have an occasional mild sensation like a twinge (mostly from the new spots). Been self-treating with witch hazel, hydrocortisone cream, fexofenadine and acetaminophen. Note: I am assuming this is a side effect from Covid vaccine because I have never before had hives. I had a senior flu shot in October with no side effects.
67 2021-01-29 numbness slight numbness in right side of head lasting approximately 10 minutes
67 2021-01-31 seizure Seizure, 60 sec generalized clonic-tonic
67 2021-01-31 facial pain Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux dise... Read more
Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux disease), symptoms started at 11:30PM while in bed and lasted 1-2 hours; sudden onset and dissipation
67 2021-01-31 weakness day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipat... Read more
day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipated with only small soft BM after product use; self care
67 2021-01-31 tingling, numbness tingling and numbing on left side of torso around rib cage, movement medially and down over a few da... Read more
tingling and numbing on left side of torso around rib cage, movement medially and down over a few days.
67 2021-02-03 tenderness 3 days following vaccine, experienced tenderness and discoloration in left hand. With it was tendern... Read more
3 days following vaccine, experienced tenderness and discoloration in left hand. With it was tenderness in my hand and wrist, by the 3rd day, I woke with throbbing pain in my knuckle joint with swelling and redness. Since then, the swelling and pain has progressed to additional knuckles in my left hand and into my right hand. There has also been joint pain in my left shoulder that resolved. Yesterday my right knee began to hurt. I've used ice packs and alternated between ibuprofen and acetaminophen for the pain. The swelling has somewhat improved but has not resolved. The pain is still present. I've had occasional join pain before but nothing like this and it has always resolved. Not sure if this has anything to do with the vaccine, but since joint pain was listed as a side effect, I thought I should report it. Have not contacted my physician yet.
67 2021-02-03 feeling hot Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin le... Read more
Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin lesions 4.5 to 7cms/Red spot on my arm; Low grade temperature elevation; Fatigue; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899, reported as "SARS-COV-2 then it says Pfizer EH9899", expiry date: Unknown), subcutaneous on 05Jan2021 at single dose for COVID-19 immunization (reported as "To not get COVID 19"). Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) 25mcg, once a day for hypothyroidism. The patient got the vaccine last Tuesday (05Jan2021). When she got the vaccine, the gentleman was from military who gave the vaccine. The patient does not believe that he gave it intramuscular (IM), she believed that he gave it "subQ" because she had no muscle tenderness and "skin a 4.5 by 7cm skin reaction", and it was nowhere near the deltoid muscle. The patient had a high degree of suspicion that he gave it "subQ" (subcutaneous). When asked for the anatomical location of administration, the patient stated that "He gave it on my right arm but it was not into the deltoid, I think he gave it subcutaneously. I am not positive of that but missed the deltoid, it was lower, it was below the deltoid, it was in between the deltoid and the bicep and I am assuming it was subQ because none of my muscles were sore at all after getting the vaccine, accept that big red spot on my arm". Patient asked "Now my question to you is because I looked through all your literature and I can't find anything about this". Since then the skin lesion within a couple of days it was up to about 4.5 to 7cms. It was still about that size however the redness has gone way down, "the not redness", just pink, the swelling was almost gone. The heat coming out of it was almost gone. The patient mentioned that the actual skin region was much better, it was still about the same size though. Patient was not too worried about that and stated "what am concerned about is what I've also have is a low grade temperature elevation and some fatigue. If I got it on 3 O'clock on Tuesday the 5th that would be day 9. Is the 9 days post injection for dose 1 to still have a low grade temperature elevation and some fatigue. Is that acceptable or does that indicate a problem?". Patient stated the she went to her internist and he had a look at it and he said "I had no idea, he said that they just don't have experience like this. Do you have a phone number that I can talk to somebody?". The patient was about 5' 7" (height) and about 175 pounds (weight) approximately. The patient stated that fatigue and temperature elevation started one or two days after the vaccine (Jan2021). Patient reported that she still have it. The fatigue was much less but it was there and low grade temperature elevation was still there. There was no investigation assessment. The patient assessed that the events swelling, redness, skin lesions, temperature and fatigue were related to COVID-19 vaccine, also reported as "Yes, because I never had that before and I am not taking anything now. So, it is like yes. It is definitely because that. The two main symptoms I am asking about are the fatigue and the low grade temperature elevation". Outcome of the events fatigue and skin lesion, redness, swelling and heat coming out was recovering, for low grade temperature elevation was not recovered.
67 2021-02-03 pain in extremity Her arm hurt for about a week; This is a spontaneous report from a contactable consumer (patient). A... Read more
Her arm hurt for about a week; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685, expiration date: unknown), via an unspecified route of administration on the right arm on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high, ongoing diabetes, ongoing hypothyroidism, high cholesterol and allergy. Concomitant medications included mometasone furoate (FLONASE [MOMETASONE FUROATE]) and montelukast sodium (SINGULAIR) - both ongoing and for allergy. No other vaccines administered on the same date with the Pfizer vaccine. The patient stated that she did okay with the first dose, and her arm hurt for about a week on an unspecified date. The outcome of the event was unknown.
67 2021-02-03 hot flush Pt co lightheadness. Also complain of hot flashes. 1705 bp 147/71; p 72, rr 20, 02 99 1710 bp 139/... Read more
Pt co lightheadness. Also complain of hot flashes. 1705 bp 147/71; p 72, rr 20, 02 99 1710 bp 139/64, p 80, rr 20, 02 99; 25 mg Benadryl given po 1712 - c/o lips and tongue tingling 1715 - 135/69, 65, 100% 1715 - tingling improving 1720 - 138/68, 66, 99% 1725 - tingling gone, lightheadness impoving; pt stood by chair without complaints 1730- 125/55, 66, 99%; pt feels better; pt assisted out to car.
67 2021-02-03 migraine The vaccine is metabolized through CYP450 same as the topiramate. On day 7 after the second vaccinat... Read more
The vaccine is metabolized through CYP450 same as the topiramate. On day 7 after the second vaccination, my migraines returned. They have been under complete control for over 5 years. I have had to increase the dose of topiramate in order the stop the migraines somewhat. My main concern is that topiramate is also used for seizures. If a person taking this for seizures has the same reaction as I did, they may have seizures shortly after their second dose of the MRNa vaccination (either Pfizer or Moderna).
67 2021-02-03 tingling, numbness inside of her mouth felt weird; hands starting to tingle and felt a bit numb; hands starting to ting... Read more
inside of her mouth felt weird; hands starting to tingle and felt a bit numb; hands starting to tingle and felt a bit numb; lower lip started swelling up; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (left arm) on 01Jan2021 (10:45) at single dose for Covid-19 immunization. Medical history included Hashimoto's thyroiditis, uveitis, and known allergy to some antibiotics, artificial preservatives, artificial colors, many foods like egg, gluten. Concomitant medications included levothyroxine sodium (SYNTHROID), bimatoprost (LUMIGAN), timolol, and vitamin D3; all taken on unspecified dates for an unspecified indication. The patient previously took Benadryl and Aspirin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that an hour after the vaccine (01Jan2021 11:45), the patient's lower lip started swelling up. Then it got worse and the inside of her mouth felt weird on 18Jan2021 (11:45AM). The patient's hands starting to tingle and felt a bit numb on 18Jan2021 (11:45 AM) (as reported-pending clarification). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with Prednisone 40mg. The outcome of event lip swelling was unknown; while the outcome of other events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
67 2021-02-03 feeling hot one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she start... Read more
one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events low grade fever, chills and nausea cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
67 2021-02-04 feeling cold, night sweats, pain in extremity Chills; Fever; cool; Night sweats; Soreness in arm; This is a spontaneous report from a contactable ... Read more
Chills; Fever; cool; Night sweats; Soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EK9231), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Blood pressure, ongoing Cholesterol. Concomitant medication included nifedipine (ADALAT) for Blood pressure and ongoing, atorvastatin (ATORVASTATIN) had been on this medication 6-7 year and ongoing for Cholesterol. Historical Vaccine included flu and had Soreness in her arm. The patient experienced soreness in arm on 20Jan2021; chills, cool, fever, night sweats on 21Jan2021. She woke up drenched. She imagined the fever was breaking. She woke up, and did not have a fever, and was fine other than that; She just couldn't warm up. She was cool, and the chill wouldn't go away with clothes or blankets or the fire place. The event outcome of soreness in arm was recovering, outcome of other events was recovered on 21Jan2021.
67 2021-02-04 slurring, feeling cold, tingling, speech disorder I was hospitalized with a severe reaction to my first dose of the Pfizer vaccine given 2/1/21 @ 9:45... Read more
I was hospitalized with a severe reaction to my first dose of the Pfizer vaccine given 2/1/21 @ 9:45. I was discharged Tuesday evening 2/2/21. Dr., my internist, agrees that what happened was not a vasovagal syncope (hospital?s diagnosis). My Experience: Within say 7 minutes of the injection I felt woozy, the wooziness intensified, I got intense pins and needles in my lower legs, fore arms and hands, and less so in my face. My speech became very slowed down, slurred and I had a lot of difficulty forming words. It was as if I was extremely drunk. After they called the paramedics, I was not able to get myself out of my car or walk. I lost motor coordination/control in hands and feet. I was cold, never felt faint, and had slightly evaluated blood pressure for me( normal is 110/64 paramedics got it at 152/94).
67 2021-02-04 numbness bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued... Read more
bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued; This is a spontaneous report from a contactable Nurse (the patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685, expiration date unknown), intramuscularly in the left arm, on 28Dec2020 as a single dose for COVID-19 vaccination. Medical history was not reported. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 28Dec2020 the patient experienced fatigue. On 29Dec2020 the patient states that her feet were numb bilaterally and her hands felt weak. The patient did not seek any medical attention and no treatment of the events was reported. The clinical outcome of fatigue, numbness of feet and weakness of hands was recovered (reported as "resolved entirely on its own") on an unspecified date.
67 2021-02-04 unresponsive to stimuli found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breat... Read more
found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breathing; blank stare; This is spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an 28Jan2021 (at the age of 67-years-old) at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient was found collapsed and very confused, unresponsive, and experienced difficulty breathing on 29Jan2021. The events caused hospitalization and were reported as life-threatening. The patient also experienced blank stare on 29Jan2021. The clinical course was reported as follows: The patient had a blank stare after receiving the first dose of the vaccine. The patient was later found collapsed and very confused. She was taken to the hospital, became unresponsive, and had difficulty breathing. The patient required intubation and sedation and remained in hospital. Therapeutic measures were taken as a result of found collapsed and very confused, unresponsive, and difficulty breathing as aforementioned. The clinical outcome of found collapsed and very confused, unresponsive, difficulty breathing, and blank stare was unknown.
67 2021-02-04 numbness left arm numbness; lightheadedness; This is a spontaneous report from a contactable pharmacist. A 67... Read more
left arm numbness; lightheadedness; This is a spontaneous report from a contactable pharmacist. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), intramuscular on 22Dec2020 10:15 AM at single dose on left arm for COVID-19 immunization. Vaccine facility type is hospital. Patient is not pregnant. Medical history included latex allergies. The patient's concomitant medications were not reported (unknown if there are other medications in two weeks). The patient previously took codeine, ibuprofen and prednisone and experienced allergies. No other vaccines in four weeks. No COVID prior vaccination. The patient experienced left arm numbness and lightheadedness on 22Dec2020 at 10:15 AM. Patient was awake, alert and oriented to date, place and person (AAOx3). Rapid response arrived and offered a snack and a drink. Patient was released after brief monitoring. No treatment was given for the events. Outcome of the events was recovered on an unspecified date. Patient was not tested for COVID post vaccination.
67 2021-02-04 pain in extremity received both shots): first - 1/9; second 1/30 normal arm soreness at first which went away; then ye... Read more
received both shots): first - 1/9; second 1/30 normal arm soreness at first which went away; then yesterday woke up and the arm is very warm to the touch and red about 4in by 3in at the injection site; no symptoms at all after the first reaction
67 2021-02-07 weakness 15 minutes after client received vaccine client stated that she felt dizzy and weak. Vital signs ob... Read more
15 minutes after client received vaccine client stated that she felt dizzy and weak. Vital signs obtained by EMS BP 119/72, Pulse 72, Temp 99, O2 sat 96% Blood Sugar 107 at 1:43 pm. Client was wearing 2 face masks. She removed the mask and stated she feels better. States she was hungry. After EMS obtained 2 sets of vitals within normal limits, patient stated she felt better and was discharged home by EMS at 1:45 pm.
67 2021-02-07 pain in extremity Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; D... Read more
Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; Diarrhea; Abdominal pain; Joint/muscle pain; Joint/muscle pain; Nausea; Fatigue; Severe headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration in the right arm on 15Jan2021 13:00 at SINGLE DOSE (first dose) for COVID-19 immunization. Medical history included systemic lupus, "hypothyroid", Leiden Factor V. Patient's known allergies: penicillin, erythromycin and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included hydroxychloroquine, clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity, tetracycline and experienced drug hypersensitivity. On 15Jan2021 16:00, the patient experienced fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm. Outcome of events was fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm not recovered. Outcome of the other events was unknown. Patient did not receive any treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
67 2021-02-07 numbness Within 5 mins, pt notified staff she felt she was having a reaction. Pt c/o shortness of breath, che... Read more
Within 5 mins, pt notified staff she felt she was having a reaction. Pt c/o shortness of breath, chest pain, bilat leg numbness, no hives present, denied difficulty swallowing. Pt was brought to a room, placed on 02 10L by face mask. Initial BP 200/105 HR 116. Pt became non-verbal, PA-C dx'd stridor, epi 0.3mg was given deep IM to right thigh. Pt responded positively, within 2 mins, pt became alert and was able to respond to questions. EMS was contacted, arrived and took pt to hospital. She was unable to ambulate c/o of all over body numbness, racing HR. Pt was admitted for observation at Medical Center.
67 2021-02-07 feeling hot blood pressure went up considerably; Heart racing; suddenly felt very warm; This is a spontaneous re... Read more
blood pressure went up considerably; Heart racing; suddenly felt very warm; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 21Jan2021 at 14:45 (at the age of 67-years-old) as a single dose for Covid-19 immunization. Medical history included a history of asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination or additional vaccines on the same day. On 21Jan2021 around a half hour after administration (also reported as within 40 minutes) the patient started having symptoms of suddenly felt very warm, her blood pressure went up considerably and her heart was racing. The patient went to Urgent Care and Urgent Care advised to take her to the Emergency Room as they did not have an EpiPen. The patient was advised to go to the Emergency Room and was in transit to the ER. The clinical outcome of the events blood pressure increased and palpitations was not recovered; for feeling hot it was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
67 2021-02-07 pain in extremity terrible case of diarrhea; arm is sore; This is a spontaneous report from a contactable consumer (pa... Read more
terrible case of diarrhea; arm is sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3749), intramuscular on 20Jan2021 15:30 at a single dose on left arm for COVID-19 immunization. Medical history included ongoing COPD, diagnosed probably 7 years ago. There were no concomitant medications. The patient's arm began to get sore the day after receiving the vaccine, 21Jan2021. She had a CAT scan earlier last week, but this was prior to the vaccine. She had the terrible case of diarrhea this morning, 22Jan2021, but she hasn't had diarrhea since then. She got up this morning. She was feeling fine, she drank 2 cups of coffee. She was pouring herself a cup of orange juice, and she had a terrible case of diarrhea. The outcome of the event diarrhea was unknown, arm is sore was recovering. Vaccination Facility Type was Physician's office. Adverse events did not require a visit to Emergency Room nor Physician Office. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations.
67 2021-02-08 tremor Hand tremor; BP 167/78; 156/78 (pulse 84, 78). Advised to f/u with PCP regarding high BP.
67 2021-02-08 weakness Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unw... Read more
Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation. Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3. Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills. Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-02-09 pain in extremity, cold sweat, feeling cold, numbness Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb a... Read more
Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb and go numb a bit; arm began to hurt then throb and go numb a bit; The patient was cold; clammy; the first blood pressure was 90 over something/second blood pressure was 70 over 40 something; diarrhea; tired; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 3247), via an unspecified route of administration in the left arm on 18Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 18Jan2021 10:10, the patient's arm began to hurt then throb and go numb a bit. On 18Jan2021 10:15, the patient started sweating. She stood up to try and feel better. The patient's husband called the nurse over and they called the paramedics because they said the patient was cold, clammy, and still sweating. The patient sat down again and they put leads on me to check her heart rate, blood pressure (BP), and oxygen on 18Jan2021. Her heart rate and oxygen were fine but the first BP was 90 over something. A few minutes later, she closed her eyes and could have fallen asleep right there. Her second BP was 70 over 40 something. She opened up her eyes and tried to stand up again. After a few more minutes, her BP came up and was OK. They refused an ambulance and went home. She had diarrhea at home on 18Jan2021. She ate, walked and felt better. She just experienced the normal tired and hurt arm in the afternoon on 18Jan2021. She rested the balance of the day. On Wednesday (20Jan2021), she got a bumpy itchy rash on both legs which is still present but with cream, it was OK. No treatment was received for the adverse events. Outcome of the "the first blood pressure was 90 over something/second blood pressure was 70 over 40 something" was recovered on 18Jan2021 and of the remaining events was recovered on Jan2021.
67 2021-02-09 tingling Muscle pain left arm 20 hours; Left foot felt like electric shock, vibrated and was stiff and out of... Read more
Muscle pain left arm 20 hours; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: E19262 and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included peanut allergy. Patient was not pregnant at the time if vaccination. There were no concomitant medications. The patient experienced muscle pain left arm for 20 hours. Pain in arm muscle only when moving arm. Her left foot felt like electric shock, vibrated and was stiff and out of control for 7 times during same time as arm pain. Each episode lasting only 2 to 3 seconds. The events happened on 21Jan2021 12:00. Patient recovered from the events and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
67 2021-02-09 numbness Red, itchy rash over body, numbness in face and lips, red, itchy eyes this lasted for about 20 minut... Read more
Red, itchy rash over body, numbness in face and lips, red, itchy eyes this lasted for about 20 minutes, then began to subside - the swelling and numbness in face and lips first and then the itching of rash - rash went away and also itching and redness in eyes
67 2021-02-09 weakness chills; weak; feeling very tired; This is a spontaneous report from a contactable consumer (patient)... Read more
chills; weak; feeling very tired; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 67-year-old female patient received first dose of bnt162b2 (lot/batch number not provided), via an unspecified route of administration on 21Jan2021 at 1:00 (unspecify AM/PM) at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her 1st dose of vaccine, on the 4th day (25Jan2021) she feels weak, have chills and no fever. It was reported that it has been four days since she had her first Pfizer injection of Covid vaccine. Stated that she is feeling very tired, weak and has no chills (pending clarification). Stated that she is four days into it. Stated that she had the vaccine at 1:00 on 21Jan. Stated that she has the list with chills which says that they are normal. Wanted to know if this is normal. The outcome of the event was unknown. Information on the lot/batch number has been requested.
67 2021-02-11 weakness On Christmas day I was working and then you started feeling like a pinching in my chest, like when y... Read more
On Christmas day I was working and then you started feeling like a pinching in my chest, like when you are going to catch a cold, that went on through the afternoon. In the afternoon I started with light headache and dry cough (intermittent), no temperature. I did not take anything for it and continued working. When I got home, I felt weak and was supposed to join my family for Christmas and decided not to go. And went to sleep. The next day (Sat) I was still not feeling well, weakness on my limbs, I went to the hospital to see if I could get checked and they told me to return on Monday because Occupational Health was closed on the weekends. I went home and treated myself with Tylenol and Vitamin C. On Monday I got tested and was positive. By then, I was coughing, limbs weak, had temperature (101F). I started to get weaker an weaker and Tuesday or Wednesday my work called me and asked me if I would like to come see a doctor. Wednesday I started with shortness of breath. I called my PCP and he prescribed me an albuterol inhaler. It helped me but my cough got worse by Saturday. My doctor then told me to go to the hospital (I live by myself). At my choice I went to Medical Center and were admitted and was hospitalized for 6 days. They kept treating me with inhaler and oxygen. They wanted to send me to rehab but I told them I wanted to go home. I came home with oxygen and with albuterol inhaler and the ambulance had to bring me home. I still was feeling very weak, had cough, and had the shortness of breath. And I have been home since then. I have home health and a therapist that come check on me 2X a weekly.
67 2021-02-16 weakness Very weak, fever 39.9, chills for three days
67 2021-02-21 tremor 34 hours (2:00 am on 2/19/21) after injection I woke up with stomaching cramping and nasuea. At 3:00... Read more
34 hours (2:00 am on 2/19/21) after injection I woke up with stomaching cramping and nasuea. At 3:00 a.m. I was dizzy and had uncontrollable shaking over entire body for approximately 45 minutes. The nausea continued throughout the entire day on 2/19/21. I contacted the Department of Health today, but whomever I spoke to did not seem interesed in hearing about it and did not ask any questions or for any information.
67 2021-02-21 weakness, tingling, inability to speak I received the 2nd Covid injection. I went to the 15-minute waiting area. The waiting area was ful... Read more
I received the 2nd Covid injection. I went to the 15-minute waiting area. The waiting area was full, so my husband and I were standing. I stand and work every day, so this was not difficult. I texted my daughter, who is a hospital employee, and told her that we had a super experience with no wait and had already received our 2nd dose. However, 5 to 7 minutes after the injection, I SUDDENLY felt dizzy and weak and had to sit down. Within a minute or so, I could not stand or open my eyes. The weakness made it difficult to breath or talk. My husband had to lift me up into a wheelchair. I was taken to the ER. For the longest time, I could not even open my eyes or talk above a whisper. After 4 hours, I was able to get my eyes open and talk better. I, gradually, was able to move my hands and feet. Last of all, I could move my hips and walk. It was as if my body had been put to sleep. I could feel everything but my body wouldn?t move. As it wore off, my face and limbs felt slightly tingly. I was, basically, fine after 5 hours other than being tired from the experience. The doctors had no explanation for what happened and said it must be an emotional response to getting the shot. They wrote that I was not exerting enough effort to move my body. One said that I was hyperventilating when I pulled my mask up to breathe after he told me to hold my leg in the air. Though I tried, I was too weak to hold my leg up and it fell to the bed. The doctor told me that I should not tell anyone about what had happened or people would not come to get the Covid vaccination. He obviously knew that SOMETHING had happened that I couldn't control but he didn't put that in his report!
67 2021-02-21 discomfort Noticed blood in urine about 2 pm on day of injection (Sunday Feb 21, 2021). Also blood in urine at ... Read more
Noticed blood in urine about 2 pm on day of injection (Sunday Feb 21, 2021). Also blood in urine at about 5 pm and 9 pm that day. Also the next morning at 7:30 am and 10:15 am but gone by 4 pm when I am writing this up. No pain on urination. Some discomfort inside. Had general and ob/gyn check up already scheduled for tomorrow at 8 am.
67 2021-02-22 tingling, numbness, pain in extremity I got very tired and I felt achy. I started feeling a tingle and numbness in my hands and fingers. I... Read more
I got very tired and I felt achy. I started feeling a tingle and numbness in my hands and fingers. I had pain around the base of my thumb on my left hand.
67 2021-02-22 tingling Patient developed tingling throughout her left arm and hand shortly after injection. She denied any ... Read more
Patient developed tingling throughout her left arm and hand shortly after injection. She denied any strength or sensation deficits. She reported that the symptoms were relatively minor but were not improving. She was encouraged to follow up with her PCP.
67 2021-02-22 speech disorder The patient became acutely short of breath and was unable to speak momentarily. She was waiting the ... Read more
The patient became acutely short of breath and was unable to speak momentarily. She was waiting the requisite 15 minutes and once we evaluated her she was administered an Epi-pen immediately. In a few minutes, her breathing returned to her baseline and she was able to speak in full sentences. Clinically, her BP was stable and she was not tachycardia. Pulses were strong. Also, given 25 mg Benadryl at the time. She
67 2021-02-23 night sweats 2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like fee... Read more
2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like feeling, "heavy head", lethargic 2/9-2/10: Pretty much back to normal with the addition of an injection site "hot spot"- raised, rashy and feverish 2/11: Began feeling general malaise in the afternoon. Low grade fever, pain behind collarbone on both sides. By 7pm, severe chills. 2/12: Called PCP and advised of symptoms. Went and got a Covid19 PCR test just in case. Negative 2/13-2/15: Still had low-grade fever (usually around 100*) which often didn't present until 2pm and then stayed until bedtime. Glands became swollen, bad night sweats. Pain behind collarbone worse when sneezing, coughing, yawning, burping, etc. Additional information for Item 18: Almost like a "catch" rather than constant pain. 2/16: Went to local medical center for drive-thru rapid Covid 19 and flu test. Both came back negative as did the PCR Covid test they also ran. 2/17-2/20: Symptoms pretty much the same....no fever in the am and thought I was finally getting better, then it would spike again around 1:00-2:00. Never over 101*. On the morning of 2/21, the "catch" around the collarbone had moved down to the bottom of my ribcage. 2/22: Contacted PCP again and made appointment for bloodwork, chest x-ray, and further tests. "Sick and tired of feeling sick and tired!"
67 2021-02-23 weakness Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness. P... Read more
Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness. Patient monitored for 30 minutes by EMS, VSS, lung sounds clear, SPO2 100%. Patient remained on-site for an additional 15 minutes then went home.
67 2021-02-23 weakness, feeling hot Pt. at 9:05 am at observation line was having weakness of the body, dizziness and felt a heat flash ... Read more
Pt. at 9:05 am at observation line was having weakness of the body, dizziness and felt a heat flash over her body. Paramedics assessed pt. once symptoms subsided the paramedics let pt. leave tent 1.
67 2021-02-24 feeling hot Because of all of my allergies I took 25 milligrams of benadryl 30 minutes prior to the vaccine in... Read more
Because of all of my allergies I took 25 milligrams of benadryl 30 minutes prior to the vaccine injection. Just a few minutes less than an hour after vaccine injection, my face turned beet red and got flaming hot. After 40 minutes of a red, hot face I took another 25 milligrams of benadryl. Now two hours and 40 minutes later my face is much less red and much less hot.
67 2021-02-24 pain in extremity Strong pain on the left arm, between back and scapula, and axillary pain. I only had taken acetamino... Read more
Strong pain on the left arm, between back and scapula, and axillary pain. I only had taken acetaminophen. Having a slow recovery. Today, 4th day after the vaccination with second dose still have pain but is lower.
67 2021-02-25 feeling hot, tremor Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patien... Read more
Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine 2nd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand All Collapse All 2/24/2021 Patient Date: 2/24/2021 Subjective is a 67 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, drooling, hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes none. She does not take any medications but is on Vyvanse.none. She denies any medial hx. Not on any medications. She did drink a protein shake this am. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, chest tightness and itching of skin (to R shoulder/injection site area) Patient denies fever, malaise/fatigue, nasal sores, sneezing, sore throat, frequent throat clearing, cough, shortness of breath, wheezing, rash, hives, eczema, abdominal pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 1024 02/24/21 1029 BP: (!) 180/73 (!) 150/90 Pulse: 71 SpO2: 97% Blood Sugar 108 collected at 1050 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Findings: No rash. Comments: Injection site and R arm without erythema or swelling. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) PT monitored and improving. Pt ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Pt aware of what to monitor and when to go to ED. Pt voiced understanding and appreciated. Pt able to ambulate out of the facility with ease. APRN Electronically Signed 2/24/2021 12:27 PM
67 2021-02-25 tingling tingling hands/fingers, loss of sensation and then peeling skin on palm /in between fingers
67 2021-02-26 tremor Within 5 minutes of administration pt began to experience difficulty breathing and vigorously shake,... Read more
Within 5 minutes of administration pt began to experience difficulty breathing and vigorously shake, transported to gurney and obtained vitals, pt with O2 Sat 70%, HR 88, administered one dose of epinephrine, placed 10L of O2 via facemask, pt began speaking, was alert and oriented to name and place, continued to report tightness of the chest and itching, called EMS, continued to monitor vitals, and patient transferred to ER without incident.
67 2021-02-27 pain in extremity Sore arm the first couple of days. After about 7 to 10 days I started feeling sort of dizzy. Equi... Read more
Sore arm the first couple of days. After about 7 to 10 days I started feeling sort of dizzy. Equilibrium is a little off. Sometimes vertigo. (maybe 3 episodes of vertigo)
67 2021-02-27 weakness Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fe... Read more
Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fever, headache, muscle/joint pain, nausea, dizziness with made it difficult to walk to the bathroom d/t the dizziness, general unwell feeling. I took tylenol. I applied ice packs to my neck and core body area. I was confined to the bed until Friday apprx 11:00 am until I could get up. I continue to feel "funny" in the head at times. I did not seek any Dr or hospital visit.
67 2021-02-28 tingling About six hours after the injection I experienced discomfort in my throat, mild swelling in both han... Read more
About six hours after the injection I experienced discomfort in my throat, mild swelling in both hands and face, some tingling in face, and head ache.I took Zyrtec 10 mg, Pepcid AC 20mg. Then I started to have tightness in my chest and used my albuterol inhaler. I was still having symptoms an hour later so took Benadryl 25 mg. During the night I woke up with mild wheezing and used my inhaler again. Throughout the next 2 days, I continued to have these symptoms (except for wheezing) off and on. Today, I still have some symptoms but not as often or severe.
67 2021-02-28 feeling hot I received the vaccine at approximately 1 p.m. in my left arm. I informed the technician that I ha... Read more
I received the vaccine at approximately 1 p.m. in my left arm. I informed the technician that I had allergies and had previously had anaphylaxtic reactions to foods and some medications. I had noticed that the Pharmacy was not requiring people to stay after receiving the vaccine, so I told the technician that I would stay until I was sure I did not have a reaction. No one came to check on me, and in about 15 minutes, I noticed that my scalp was starting to itch and my face felt hot. I decided to go home, which was only a 5 minute drive from the store. I took off my mask in the car and discovered that my face was very red and starting to feel tight. I got home and took 1 Benadryl pill. By the time I got home, around 1:25 my ears were itchy and my lips were starting to swell. I waited an hour and started to feel better, the color in my face was returning to normal, and I had no swelling of my throat, which I have experienced with food allergies. At hour 2 I took a second Benadryl and went to sleep for 2-3 hours. When I woke up, I felt better, my lips were still slightly swollen, but my face, scalp and ears were back to normal.
67 2021-02-28 pain in extremity Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid... Read more
Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid as well; Rapid heart beat for about an hour second day, but could be thyroid as well; Sore arm, not severe; Lethargic for a day; This is a spontaneous report from a contactable other health professional, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 26Jan2021 at 09:00 AM in the left arm (at the age of 67 years-old) for COVID-19 vaccination. Medical history included hypothyroidism, autoimmune disease, allergies to penicillin and many foods. Concomitant medications included etanercept (ENBREL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan potassium (LOSARTIN). The patient receive did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 09:00 AM, the patient experienced sore arm, not severe and was lethargic for a day. On 27Jan2021, the patient had loose bowels the second day after the shot and rapid heart beat for about an hour second day, but could be thyroid as well. No treatment was received for events, sore arm, lethargic, loose bowels, rapid heart beat and thyroid. The events were reported as non-serious. The clinical outcome of sore arm, lethargic, loose bowels, rapid heart beat and thyroid was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
67 2021-02-28 tingling Patientreported tingling hands, face and itchy throat on the outside not on the inside. 50mg of Bena... Read more
Patientreported tingling hands, face and itchy throat on the outside not on the inside. 50mg of Benadryl was given and patient was observed for an hour and stated she felt better when she left. Patient was not driving the car.
67 2021-02-28 burning sensation RASH ON FACE AND NECK WITH BURNING AND STINGING. SWELLING OF FACE AND EYES.
67 2021-02-28 tremor, tingling Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient felt faint, blood pressure dropped and 911 was called. pt's spouse informed us after the vaccination that she has this reaction with all vaccinations due to a branch block. paramedics cleared patient to leave after observation period.
67 2021-03-01 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable Consumer. This 66-year-old female con... Read more
Bell's Palsy; This is a spontaneous report from a contactable Consumer. This 66-year-old female consumer reported that received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), via an unspecified route of administration on 12Feb2021 (at the age of 67-year-old) at 05:45 PM in the left arm at single dose for COVID-19 immunization. She had received the first dose of BNT162B2 on 22Jan2021, at 06:00 PM in the left arm. The patient had no history of allergies to medications, food, or other products. Medical history included Thyroid, Panic Disorder, Mild Depression. Concomitant medications included levothyroxine, simvastatin, trazodone, clonazepam. The patient reported that early in the day, on 12Feb2021, before receiving her second dose, she began to feel something odd going on with her mouth. She couldn't really identify it, but she felt like something wasn't quite the same. It was very mild, so she brushed it off. She had her second vaccine dose, on 12Feb2021 at 5 pm. By about 7 pm that night, she was rushed to the University Name Emergency room and was diagnosed with Bell's Palsy. She was treated with Prednisone 10MG X3, valACYclovir 1g X3, polyviny. At the time of reporting the patient had not recovered.
67 2021-03-02 migraine Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5... Read more
Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5 days
67 2021-03-02 tingling One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for tw... Read more
One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours.; One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs.; very light headed right after the shot; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9261, expiry date: not reported), via an unspecified route of administration at left arm on 29Jan2021 12:45 at SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis, gastrooesophageal reflux disease (GERD), and migraine. The patient also had known allergies to multiple antibiotics, kiwi, walnuts, and bee sting. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]), topiramate, vitamin D3, guaifenesin (MUCINEX), and clarithromycin (CLARITIC). The patient stated, "One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs. I had no trouble breathing. I was also very light headed right after the shot but that resolved quickly." All the events started on 29Jan2021 14:15 (reported as 02:15 PM). There was no treatment received for all the events. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient recovered from all the events.
67 2021-03-02 numbness face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a c... Read more
face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a contactable consumer reported for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 16Feb2021 10:15 (at the age of 67-year-old) from lot # EN6200 at single dose for COVID-19 immunization via intramuscular route at the left arm. The caller stated she had a half an hour of sitting afterwards and then they let her go. Concomitant medications included loratadine (CLARITIN) for sinusitis and insulin for Type 2 diabetes mellitus. Relevant medical history included type 2 diabetic (Diagnosed about 17 years ago), allergic to some food, allergic to sulfa, she had a number of allergies and she had an anaphylactic reactions in the past, asthma diagnosed around the age of 40, sinuses, high blood pressure after a D&C, she had a miscarriage, uterine dilation and curettage, one headache before this in her entire life. The patient had received Flu vaccine on unknown date. The patient, on 16Feb2021 had headache that lasted for 5 minutes. It was right after the first shot of the Pfizer COVID-19 vaccine, her face went numb and she couldn't breathe through her nose. She was only able to breathe through her mouth. Her jaw got really numb. It happened when she was driving home from the vaccination center and she had to pull over because she might go into an accident. She wasn't sure if she was having a stroke or not but she was scared since her sister had histories of multiple strokes. She wanted to know Pfizer's recommendations for the second dose considering her adverse events. He had a really short headache tonight, He stated "it hit me out of the blue right in my temporal; I got on the floor it was so bad. 5 minutes after I left my face went totally numb" She stated she also had the second headache she had ever had in her entire life. She also mentioned she had some swelling in her arm but she didn't think that was unusual. She clarified as she was driving home after receiving her shot, her entire face went numb and her jawline went numb. It scared her so bad. She thought she was having a stroke or something. She confirmed she recovered completely from this, the numbness cleared up in 10 minutes. The Outcome of the event swelling arm was unknown while the outcome of the other events was recovered on 16Feb2021.
67 2021-03-02 feeling hot heat and redness throughout entire face
67 2021-03-02 migraine throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (... Read more
throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: unknown) via an unspecified route of administration on the left deltoid, on 27Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetic for at least 15 years. There were no concomitant medications and no prior vaccinations within 4 weeks. On 28Jan2021, patient got a migraine and on 29Jan2021, the vomiting started which was so bad her throat was still sore. The migraine resolved as of the morning of 01Feb2021. The vomiting lasted 3-4 hours and resolved the same day (29Jan2021). It was done at a clinic at a local church. There were no treatment, she just waited it out and rehydrated. Outcome of the event throat was still sore was not recovered.
67 2021-03-03 pain in extremity 3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded... Read more
3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded range between 59 and 166. 3/4 - itchy rash near injection site ( have photo)
67 2021-03-03 bell's palsy, speech disorder Bell's palsy; She cannot talk real well right now; This is a spontaneous report from a contactable c... Read more
Bell's palsy; She cannot talk real well right now; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6200, unknown expiration), via an unspecified route of administration in right arm on 16Feb2021 at 10:55 at a single dose for COVID-19 immunisation in a hospital. Medical history included chickenpox and measles (when she was a kid), COVID-19 in 2020 (last year), ongoing anxiety, ongoing blood pressure (abnormal), and ongoing insomnia. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEXA), and ongoing unspecified anxiety, blood pressure and insomnia medications. The patient received her first dose of BNT162B2 (lot number: EJ1686, unknown expiration) on 20Jan2021 at 11:33 in right arm for COVID-19 immunization. The patient's friend called on behalf of the patient because she cannot talk real well right now (Feb2021). The patient's friend confirmed that the patient went to emergency department and was told that she has Bell's palsy on 18Feb2021 at 14:00 and she has never had it before, and they did not know if it was a side effect from the COVID-19 vaccine or not. The patient received prednisone 20mg 3 times a day, Valpex, antibiotic, and eye drops for right eye as treatments. Blood test was taken on 18Feb2021 with unknown result. The patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.
67 2021-03-03 pain in extremity, cold extremities, flushing Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (t... Read more
Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (the same as when I have had radioactive dye), during my 15 minutes of observation my hands and feet were cold and sweaty and I felt a little shaky. I waited 20 minutes and went to the restroom and had diarrhea (very rare for me). I went to my car and looked in the mirror and my face was bright red and the whites of my eyes were red and my eyes were glassy. I went back in to the observation area and was given oral Benadryl. and monitored for 45 minutes. Right after I took the Benadryl my throat felt itchy (not sore - itchy). My blood pressure was 157/62 when I first sat down but came down to 130/ 60 by the time I was sent home. My bp is normally about 106/60. I was really tired at home for the rest of the day so went to be early. The next day I felt fine and my arm was only slightly sore. The doctor at the immunization clinic told me not to get the 2nd shot. I called my GP, and he too told me not to get the 2nd COVID shot and wait until more information has come out about adverse reactions to the vaccine. I did not have any difficulty breathing. I don 't know if the redness on my face went down my neck to my chest. I didn't look. I did not have a fever.
67 2021-03-03 feeling hot Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; This is a ... Read more
Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 67-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included "thyroid," high blood pressure, depression, anxiety, and osteoporosis. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. It was unknown if the patient had any allergies to medications, food, or other products. The patient received unspecified concomitant medications. The patient did not receive any pother vaccines within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced left arm red, hot, and raised at first. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of left arm raised was recovered. The outcomes of left arm hot and red was not recovered; left arm was still red and hot and it was day 12. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
67 2021-03-03 pain in extremity Severe pain in hands and knees where I have arthritis, tiredness low. Grade temp fluid retention doe... Read more
Severe pain in hands and knees where I have arthritis, tiredness low. Grade temp fluid retention doesn?t go down,
67 2021-03-03 pain in extremity Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes a... Read more
Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes after the jab, I broke out in hives on my upper thigh and stomach. By 7 PM, I felt really sick, my arm felt as though the strongest person in the world punched me, and by 8, I was shivering and wrapped in a ton of blankets, by 10, every muscle in my body ached beyond its capacity and my fever was 101.8. It got to 102.1. My head was weighed down with an unrelenting headache. Finally, an hour ago, my fever broke. I have Systemic Lupus and CRPS and do not vaccinate because my body is always attacking itself. But this year I got my first ever flu vaccine. Same results. So sick.
67 2021-03-04 tingling, numbness Experience tingling, then numbness in my hand then it went to my face which was a hardness and tingl... Read more
Experience tingling, then numbness in my hand then it went to my face which was a hardness and tingling or needles & pins in my lip, it was on the left side, the same side as the injection and started to subside after an hour and a half to 2 hours, defined a strange wierd feeling which I still very slightly feel.
67 2021-03-07 feeling hot, weakness, feeling cold, tingling About ten minutes after the shot, my heart suddenly started pounding, I was panting, and I got very ... Read more
About ten minutes after the shot, my heart suddenly started pounding, I was panting, and I got very hot. Then tingling went all over my body, even in my lips. At one point, I felt close to fainting. The pharmacist lady gave me cold water (I asked for it), and I just sat there for quite a while. Gradually my heart rate came down, and I got cold, but the tingling kept going, and I felt somewhat weak. Since I didn't want any epinephrine (it affects my heart), and I didn't think I was so bad that I needed an ambulance, after being there nearly an hour my husband drove me home. There I took some liquid Benadryl, and that seemed to help with the tingling. I just took it easy after that. Considering my reaction tothe first dose, I will NOT be getting the second one. I don't need to consult with a doctor to decide that. It was somewhat frightening because I didn't know how bad it was going to get.
67 2021-03-08 pain in extremity Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremi... Read more
Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremities started stinging, nose running & feeling feverish. My ears started ringing too & got vertigo. Also I started having trouble breathing with a slight ache/pain in my lungs. A noticible itch started in my nose & a tickle in my throat and I had extreme muscle pain, especially in extremities affected by previous carpal tunnel injuries & sciatica. Tuesday afternoon all symptoms were worsening so I used Zicam Gel swabs in my nose, made chicken garlic soup & tea with honey & went to bed. It took 3 days for the sinus, headache & respiratory symptoms to resolve. The neuropathy (skin stinging) pain in my arms, hands & lower legs persists and is very painful.
67 2021-03-09 numbness after about 5-6 hrs left side of my face became partially numb/feels like a hand is on my face/ Now ... Read more
after about 5-6 hrs left side of my face became partially numb/feels like a hand is on my face/ Now been 4 days and still somewhat numb; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 03Feb2021 09:00 am at SINGLE DOSE for covid-19 immunisation. Medical history included sjogren's syndrome, allergies to sulfa. The patient's concomitant medications were not reported. It is reported on 03Feb2021 02:00 PM, about 5-6 hours after the vaccination, left side of patient face became partially numb. Everything functions fine but feels like a hand is on her face. Went to doctor who couldn't find anything else wrong and encouraged her to still get second shot. Now been 4 days and still somewhat numb, possible getting better but hard to tell. No treatment received for the events. Outcome of the event was not recovered. The patient is not pregnant. No covid prior vaccination. No covid tested post vaccination.
67 2021-03-10 feeling hot syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills... Read more
syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills; mild pain at injection site; This is a spontaneous report from a contactable pharmacist reported for self. This 67-year-old female patient (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 13:45 PM on Arm left via Intramuscular at single dose (Lot # EL9269) for covid-19 immunisation. Medical history included Osteoporosis, known allergies: Sulfa, flu vaccine for immunisation. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), ergocalciferol (VITAMIN D), calcium, magnesium, biotin, bifidobacterium lactis (PROBIOTIC). No other vaccine in four weeks. Past similar reaction from Flu vaccine 8 years ago (2013) for immunisation and treated in ED, had no problems with any other vaccine such as HepB (Hepatitis B), DTAP, pneumococcal 23, Shingrix all for immunization. On 17Feb2021 14:15 PM, feeling of heat rising into throat, then lightheaded- EMT on-site monitored BP, heart, oxygen then administered IV Benadryl and zofran - signed out in 2hr, developed chills and syncope for next 4 days and mild pain at injection site. Self treated with Tylenol/ advised by MD to not get 2nd dose. Events resulted in emergency room/department or urgent care. Treatments were received for the events. Treatment included IV Benadryl and IV Zofran. Outcome of the events was recovering.; Sender's Comments: Based on a temporal association, a causal relationship between the events of feeling of heat rising into throat, lightheaded and syncope, and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-03-14 facial pain A rash on my forehead and that spread around the right eye for next two days; Developed pain on righ... Read more
A rash on my forehead and that spread around the right eye for next two days; Developed pain on right side of face; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231), via an unspecified route of administration on Right arm on 21Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included Allergies to Sulfa and Osteopenia/osteoarthritis. The patient's concomitant medications were not reported. The patient reported, On 28Jan2021, one week after receiving the Covid vaccine, I developed pain on right side of face. On 31Jan2021 I developed a rash on my forehead and that spread around the right eye for next two days. The Dr was contacted on 02Feb2021 and I started on Valtrex (Valacyclovir HCL, 1 Gm, 3 times a day on 28Jan2021 13:00 upon Doctor or other healthcare professional office/clinic visit). The patient received treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events recovering. Information on the lot/batch number has been requested.
67 2021-03-14 pain in extremity My arm did get sore and it had stayed sore; I am also experiencing nausea; headache; not feeling wel... Read more
My arm did get sore and it had stayed sore; I am also experiencing nausea; headache; not feeling well; felt feverish; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on her arm on 25Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included raynaud's phenomenon. She was told that she could not donate plasma because of it but she have raynauds, she stated she is not taking medications or anything for it, it's just she get chills in her hands and feet from anything if she drink anything cold or get chilled or whatever, white they turn white. It was reported that patient had Covid 19 and was tested positive for antibodies back in June. The patient's concomitant medications included estradiol (Cream, its a hormone cream), vaginally at 13 micro grams, twice a week for unknown indication and acyclovir for unknown indication. In Jan2021, patient reported that her arm did get sore and it had stayed sore and she is also experiencing nausea, she had experienced nausea that night, a headache, not feeling well and felt feverish didn't recorded fever but her concern is that it's not going away. The patient received treatment just advil (as reported). The events were considered as non-serious. The outcome of the event felt feverish was not recovered and outcome of other events unknown.
67 2021-03-14 pain in extremity nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontan... Read more
nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E1823886, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 10:00 (age at the time of vaccination was 67-year-old) on right arm at single dose for covid-19 immunisation. Medical history included allergy to Sulfa. Concomitant medication patient received within 2 weeks of vaccination included Hydrochloride, potassium chloride (K-DUR), vitamin d3, irbesartin. The patient experienced nausea, dizzy, chills, body aches, headache, trouble concentrating and very sore arm on 09Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events.
67 2021-03-15 difficulty speaking BP 142/68; like my throat is closing up; Voice hoarse; chest feeling tight; This is a spontaneous re... Read more
BP 142/68; like my throat is closing up; Voice hoarse; chest feeling tight; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265), via an unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and flu vaccine and experienced allergies. The patient was vaccinated on 05Feb2021. Patient was initially hesitant to get vaccine, reported prior bad reaction to flu vaccine. Patient spoke with the pharmacist and decided to proceed with vaccination. On 05Feb2021, approximately 2 minutes after being seated in the observation area, patient began to feel "like her throat was closing up". Another employee brought the attention of this RN who notified the pharmacist and other clinic staff. Initial assessment, patient seated, in apparent distress stating, "I feel like my throat is closing up". Voice hoarse. 25 mg diphenhydramine hcl (BENADRYL) administered. Patient declined additional 25 mg diphenhydramine hcl stating it made her too sleepy. Patient brought to private monitoring area. VS obtained. HR 78, BP 130/73, SpO2 99%. Reported feeling "some better". HR 76, SpO2 97%, BP 106/66; reported "chest feeling tight". Decision for epinephrine (Epi) administration. Epi Pen administered to L thigh. HR 89, BP 142/68, SpO2 99%. Patient taken to emergency department (ED). Care tx ED RN. Patient stable upon tx to ED. The patient required emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included diphenhydramine hcl and epinephrine. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-03-15 muscle spasms, numbness, involuntary muscle movements Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and i... Read more
Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and it felt heavy and it just dropped. She then started to raise the arm and she was not able to do it. She then suddenly lost sensation in her left arm. She then could not control it, would raise when it wanted to but was not able to feel it or control it. (had the feeling that it was not connected to her body and it was just floating around). Then started having involuntary muscle spasms in her mid torso region. The same thing then happened again and the muscle spasms were more intense and she waited around and lasted for minutes. She never lost consciousness, but then it happened again and was spreading on her left side. It then encompassed from her hip up to her shoulder. The involuntary muscle spasms were moving from the side toward her chest to where she felt it would impact her breathing. She then went to the ER and they started doing testing, and she had more spasms, and then started having double vision. In talking with the doctor about all of this she had a CVA with complex partial epilepsy with recurrent seizures and that the double vision was related to the infarct in her brain and that the stroke triggered the seizure that she had. She did not lose any memory, loss of consciousness, no weakness or loss of sensation. These episodes only lasted minutes and a refractory time of minutes and when she got to the ER she the other episode when they were trying to test her. They were not able to do the EKG or EEG due to the involuntary movements and these resolved. She is now completely recovered other than the fatigue with no residual. She saw a neurologist on 2/24/21 who felt like that she had a stroke and put her on Keppra and is going to FU in 3 months at IU. It was ruled out that there was no relationship of her transplant to this reaction. She is now on Keppra, Atorvastatin for the swelling in her brain, and also put on aspirin 81 mg. Her blood tests that were done were all drawn and were all within normal limits except for kidney function, but is only a minor #'s for her secondary to the transplant. She then had some titers drawn for CMV and that was also negative. Then she had a COVID test that was negative. Then she had spinal tap that came back normal results.
67 2021-03-15 pain in extremity pinching all over body; mildly nauseated; Plantar fasciitis; The pain in my foot became excruciating... Read more
pinching all over body; mildly nauseated; Plantar fasciitis; The pain in my foot became excruciating; could barely walk; The pain in my foot became excruciating; could barely walk; This is a spontaneous report from a contactable Consumer (patient). A 67-year-old female patient received second dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= EL9263), via an unspecified route of administration in right arm on 19Feb2021 09:30 AM at single dose for COVID-19 immunization. Medical history included known allergies to Sulfites, Iodine as contrast, Dairy, Gluten. Concomitant medication included levothyroxine, liothyronine (NP THYROID), latanoprost (LATANOPROST) and Supplements (Other medications in two weeks). The patient was not pregnant. The patient did not have COVID prior vaccination. The patient did not have COVID tested post vaccination. The patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= COVID-19 immunization), via an unspecified route of administration in right arm on 29Jan2021 11:30 AM at single dose for COVID-19 immunization. The patient did not have other vaccine in four weeks. 19Feb2021 after 2nd shot: pinching all over body and mildly nauseated. Plantar fasciitis left foot had no pain for 24 hours. 24 hours later: no nausea. The pain in the foot became excruciating; could barely walk. Lasted 2 days. Milder now. Adverse event start date was 19Feb2021 10:30 AM. The outcome of the events was recovering.
67 2021-03-17 numbness My face went numb; Headache; This is a spontaneous report from a contactable consumer. A 67-years-o... Read more
My face went numb; Headache; This is a spontaneous report from a contactable consumer. A 67-years-old non-pregnant female patient received BNT162b2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, in the left arm, on16Feb2021 at 10:15 (at the age of 67 years-old) as a single dose for covid-19 immunisation. Medical history included headache, anaphylaxis reactions to food allergies, Spinich, cabbage, sulfa based drugs diabetes, and asthma. The patient had not received any other vaccinations within 4 weeks and was not diagnosed with COVID-19. Concomitant medication included diabetes meds and insulin glargine (BASAGLAR). The patient reported on 16Feb2021, at 10:45 after waiting 30 as instructed, I had a reaction 5 - 10 minutes later. My face went numb, and then a headache started. I have had only 1headache in my life prior to this. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the event was recovered
67 2021-03-18 weakness Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her a... Read more
Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her appetite; heard in the background stating the COVID-19 Vaccine screwed up her mind; Headache; Eyes hurt/Her eyes felt like they were going to pop out; Feels tired and weak; Feels tired and weak; can't think straight; pain in head and stomach; change of mood; altered mental status and nightmares; altered mental status and nightmares; she is so mean to everybody / not acting normal; her eyes felt like they were going to pop out; Suicidal thoughts/thinking of committing suicide; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL267, expiry date 31May2021) via an unspecified route of administration, at the age of 67-year-old, on 24Feb2021, as SINGLE DOSE (0.3mi as reported) for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and ongoing allergy to penicillin. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9265, expiry date 31May2021) via an unspecified route of administration, on 03Feb2021, single dose for covid-19 immunisation wherein the patient had to got to Emergency room and it was found that her magnesium and potassium were low. The patient had a super bad reaction to the Pfizer vaccine. Patient's mind has not been normal ever since and she is so mean to everybody. The patient was fine until she got the vaccine. The reporter has had the ambulance and police up there to try and help but the caller wouldn't go out to the hospital. The patient had a normal mind before she got the shot. The patient has a bad headache that will not go away (8 days) and her eyes are hurting really bad/eye pain/ eyes hurt. She feels so tired and weak. The second COVID-19 Vaccine messed the patient up. She had the same symptoms for both first and second dose (unspecified symptoms), but the second dose has really messed up her mind. Patient probably won't have a mind. It was reported that the patient's mind was alright, but the second COVID-19 Vaccine did her in. Now patient is saying she won't get her mind back. It has messed up her mind. Clarified when caller states it messed up her mind, he is referring to the patient being mean. Stated patient did have a headache, but wasn't hateful. Stated patient's mind is so bad, she is just mean. If patient doesn't get help soon she is going to tell herself good night. Patient stated in background "If I don't get my mind back I'm going to end up killing myself because he made me." At 11PM last Wednesday (24Feb2021), patient starting losing her mind. Confirmed with caller that patient is currently having suicidal thoughts. Patient used to be a real nice lady and blames this on the COVID-19 Vaccine. Patient is afraid she is not going to get her mind back. Advised caller to seek emergent medical attention for the patient. Patient is against everybody now because of the crazy COVID-19 Vaccine. Patient heard in the background stating the COVID-19 Vaccine screwed up her mind. Caller stated patient is quite upset with everybody. Patient is not acting normal. Patient doesn't think her mind will ever get straightened. The medicine was too much for her body. After getting the second dose, the patient lost her mind, she's lost her appetite/ No appetite and went 32 hours without eating, can't think straight, altered state of mental, mental fog, pain in head and stomach, change of mood, nightmares, her eyes felt like they were going to pop out. Her doctor said it was probably an overdose. The patient was not like this prior to second dose. Outcome of the event was unknown. The reporter believes her mental fog is due to second dose of vaccine.
67 2021-03-18 flushing Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; F... Read more
Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; Freezing and chills; Felt like would pass out/felt so faint; Ate dinner but food came back up; Shortness of breath; Cheeks flushed; Achy; felt draggy/feeling tired; This is a spontaneous report from a contactable. A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: GL9266, via an unspecified route of administration, administered in left arm on 21Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatic fever (occurred age 7), vulvovaginal dryness and sore joints. The patient was negative on Covid test on an unspecified date. Historical vaccine included BNT162B2 on 28Jan2021 for COVID-19 immunisation and flu shot. Concomitant medications included estradiol (IMVEXXY) taken for vulvovaginal dryness; vitamin C [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); calcium. On Monday, 22Feb2021, the patient felt draggy, but did not think it was a big deal. She just thought it was from the shot and was feeling tired. The draggy feeling lasted a few days, but she was unable to clarify outcome further. On Tuesday, she started to feel achy and felt like that too was to be expected. The achiness went away on 25Feb2021. On Wednesday, 24Feb2021, she was really busy. She was still achy but was busy. She also did not drink much water for several hours. It dawned on her later when she was not feeling good. Late Wednesday afternoon it was like everything cratered and she felt horrible. She was feeling bad. She was freezing and had chills. It was a horrible feeling. She helps with her grandkids since she is retired. They were home from school and had to sit on the couch. She felt cold, yucky, and achy. It was a yucky feeling. She went home a couple of hours later. She told her husband she had to lie down on the couch because she felt horrible. She could not further describe horrible feeling. Her daughter had called her as well and was unable to describe how she felt to her daughter. She could only say she felt so sick but could not explain further. She felt awful and could not put her finger on it. She was laying down and when she got up, she felt like she would pass out. At that time, she had not eaten dinner yet. She ate dinner, took one bite and the food came back up. For a few moments she felt so faint, she felt shortness of breath, but it was only for a few seconds. After that, her and her and her husband took a drive to go to hospital. However, by the time she got to hospital she was feeling better. She was also talking to a friend at that time who said all of this was probably form the shot as well. Since she was feeling better decided not to go into the hospital and went back home. At the time she was thinking this was all from the shot and no big deal. On Wednesday night, things got crazy and worse. That evening Wednesday she was getting ready for bed and noticed her cheeks were flushed. On Thursday she got up and noticed rash. She was covered all over her body. It did not itchy really, but it was a rash. Not a bumpy rash, it reminds her of Roseola. Her joints and fingers were starting to swell. Her hands were swollen. It started with her knuckles, it went to her fingers, up to her hands, wrist. Her wrist was sore. Her joint swelling was worse. On Friday, she tried to see her doctor, but could not be seen by the doctor. However, she got in with the PA. When she saw the doctor, it could be seen her hands were swollen. However, the main reason she went to the doctor was due to the rash. However, her joints were sore and swollen. Treatment for rash included Hydroxyzine, for joints and fingers swollen/ wrist was soreincluded prednisone 10mg one tablet every day for five days. The patient recovered from the event felt like would pass out/felt so faint and shortness of breath on 24Feb2021. The outcome of the events joints and fingers swelling/hands were swollen, wrist was sore and cheeks flushed was not recovered.
67 2021-03-18 tremor feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nause... Read more
feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nauseous; accelerated HR; she had body shakes/body was trembling; to the point she thought she was going to pass out; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL1284) at vaccination age of 67-year-old via an unspecified route of administration on 28Jan2021 at a single dose to prevent COVID19 (covid-19 immunisation). Medical history included interstitial lung disease and overactive thyroid (She was treated for overactive thyroid, but it has been stable for five years). Concomitant medication included nitrofurantoin for interstitial lung disease and fluticasone. The patient previously took prednisone [prednisone acetate] (She did ten weeks of Prednisone and has been off Prednisone since the middle of Nov2020. She started at 30mg and tapered down to 20mg then to 10mg and then to 5mg until she was done). The patient experienced feeling lightheaded, mild headache, fatigue, erratic bp 01Feb2021 11:30, feeling nauseous on an unspecified date in 2021. Took Pfizer Covid 19 vaccine last week. Began feeling lightheaded, mild headache, fatigue, erratic BP on Monday, 4 days after receiving the vaccine. Went to Emergency department on Monday evening. Has been continuing off and on since Monday. Can these symptoms occur after 4 days patient questioned. Has already reported to DSU. She got Pfizer's COVID19 Vaccine a week ago today. She was doing fine and then Monday she started with mild headache, erratic blood pressure readings. She ended up in the ER because it was so high. It stabled out and she went home. She was feeling ok on Tuesday, but not quite normal. She was fine yesterday until last night then it started again with erratic blood pressure, fatigue, mild headache and lightheadedness. The headache is never pounding. The lightheadedness won't go away. Is that normal to have that many days after receiving the vaccine? It was four days before she started experiencing it. Now she feels kind of normal as long as she is laying down except for headache. As of 15Feb2021, the patient reported that she called a couple weeks ago and reported adverse side effects and she needed a couple questions answered. She mentioned that she was due to have the second vaccine this weeks (18Feb2021). She was extremely worried about doing it because even some of the effects she had after 4 days in the first vaccination have not subsided. She added that it landed her in emergency room a couple of times (also reported as ended up in the ER twice). She inquired if should she take the second one at this point or can she wait and if she can wait for how long. She mentioned that she had a spike in her blood pressure (BP), she had accelerated HR on an unspecified date in 2021, she was very lightheaded to the point she thought she was going to pass out on an unspecified date in 2021. The second time around, her body was trembling on an unspecified date in 2021, she had body shakes. It was not fun. All of these effects have returned to somewhat normalcy, but she is still experiencing lightheadedness. She has seen her own physicians, but she is not sure if she should proceed with the second vaccine. The outcome of the event lightheadedness was not recovered while the outcome of the other events was recovering. Follow up (15Feb2021): New information received from a contactable consumer (patient) included: lab data, new event (accelerated HR, to the point she thought she was going to pass out, body shakes/trembling) and clinical course of the events.
67 2021-03-20 weakness, slurring Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradu... Read more
Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradually better over 45?. Tried to leave didn?t get out of bldg, collapsed in chair bad chest pain felt really bad. Ambulance called, gradually progresses to weak r side hi b/p slurred stammering speech inability to swallow tongue thrusting to Uc health ct w contrast ok. Gradually improved discharged at 1700. Saw doctor following Monday. Cardiac work up scheduled 4/5/21 She does not want 2nd vaccine until cleared by cardiologist. I have had bouts of chest pain. Hospital tadmitted me as Jane doe. Severe fatigue sleeping 12-14 h/ d for 5-6 d no fever flu sx. Low energy. Hospital never took he from me once better discharged as migraine but I don?t have migraines
67 2021-03-21 feeling hot, tingling, burning sensation right cheek redness; right cheek redness and rash with burning; right cheek redness and rash with bu... Read more
right cheek redness; right cheek redness and rash with burning; right cheek redness and rash with burning; itching; tingling sensations; felt hot; dizzy; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration, administered in the left arm on 28Jan2021 as a single dose for COVID-19 immunisation. Medical history included hypertension and hypothyroidism, both from an unknown date and unknown if ongoing. The patient had COVID prior vaccination (dates unspecified). The patient was not pregnant at the time of the vaccination and report. The patient's concomitant medications were not reported. The patient had known allergies to aspirin, codeine, metoclopramide, morphine, hydromorphone, tramadol, hydrocodone, and prochloperazine maleate (COMPAZINE). The vaccination was done in the hospital. In Jan2021 (also reported as 18Jan2021), patient experienced right cheek redness and rash with burning, itching, tingling sensations. The patient also felt hot and dizzy. The events caused hospitalization from an unspecified date in 2021. The patient was not tested for COVID post vaccination. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
67 2021-03-23 tingling, numbness Numbness and tingling of both legs and feet which continue since day two of the second Covid 19 vacc... Read more
Numbness and tingling of both legs and feet which continue since day two of the second Covid 19 vaccine; Numbness and tingling of both legs and feet which continue since day two of the second Covid 19 vaccine; This is a spontaneous report from a contactable consumer reporting for self. This 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 02Mar2021 12:15 in right arm for COVID-19 immunization. The first dose was on 09Feb2021 12:15 PM in right arm. Medical history was not reported. There was no allergies to medications, food, or other products. There was no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced numbness and tingling of both legs and feet on 04Mar2021 01:00 which continued since day two of the second COVID 19 vaccine. There was no treatment received for the adverse event. The event was considered serious due to disabling/incapacitating. The outcome of event was not resolved. The information on the lot/batch number has been requested.
67 2021-03-25 weakness, feeling hot, feeling cold Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized ac... Read more
Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized aching; Fibromyalgia flare up; No energy been very tired; No energy been very tired; Felt like she was going to faint; Dizziness; Vision blurred; Loss of appetite; Flu-like symptoms; Hands feel warm to touch, but she still feels cold; She cannot sit or stand without discomfort in her spine; She cannot sit or stand without discomfort in her spine; Sick; Her bones and muscles hurt; Her bones and muscles hurt; Wheezing; This is a spontaneous report from a contactable Other HCP, the patient. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE,Lot Number: EM9809; Expiration Date: 30Jun2021), intramuscularly, on 01Mar2021 at 13:45 (at the age of 67 years old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included having become disabled in 2009, arrhythmia from 2014 and ongoing which was diagnosed after she took a Hep C treatment (Sovaldi, Ribavirin, Olysio). She had to take these medications for five months, where most people have to take it for three, ongoing allergic asthma - allergic to "everything." She has had this her whole life, diagnosed when she was 5. Started treatment with steroids at 16 , Hepatitis C from 1996 to 2014 diagnosed 4 years after blood transfusions Could have already gotten it as a nurse, was much more resistant than the average person 5 weeks to go negative, ongoing hepatic failure from 2013- she went into liver failure from Hep C. An event occurred- exposure of a deadly toxin that came from China, ongoing fibromyalgia from 1992 -Immediately after blood transfusions when her son was born- Gave her the correct blood but her body reacted. Flu shot in Early Oct2020 Fibromyalgia flare up, 4 times the dose (as reported)- Onset Age 66, Seizure disorder which was diagnosed in 2016 after disseminated shingles; after 2.5 months started having black outs where she did things and said things no memory of, the only way she knew it happened is if there were consequences. Doesn't know if she still has those, but she is getting an MRI and EEG. She lost vision in her right eye 2 years ago due to retina surgery macular pucker. She thinks her liver was stealing Vitamin A from her eye. Medical history also includes she ran over herself with her car, blood pressure abnormal, hepatic encephalopathy, autoimmune thyroiditis, and anxiety all from unknown dates and unknown if ongoing. The patient has had cataracts since an unknown date prior to the vaccination. The patient was diagnosed with "Rocky Mountain" in 2009. She also mentioned that when she got the vaccine she did not tell them that she was on steroids and an antibiotic. She commented that she was not in good shape when she took the vaccine to begin with. She is immunosuppressed and thinks that she should not have received the vaccination. But she also stated that she took the vaccine because she is a severe asthmatic and does not have a strong immune system so if she got COVID, she would die. Concomitant medication included benazepril (BENAZEPRIL) for blood pressure abnormal from an unspecified start date and ongoing; amlodipine (AMLODIPINE) for arrhythmia from 2014 and ongoing; rifaximin (XIFAXAN) for hepatic encephalopathy from 2014 and ongoing; lactulose (LACTULOSE)for hepatic failure, ammonia abnormal from 2014 and ongoing; levothyroxine sodium (SYNTHROID) for autoimmune thyroiditis from 1984 and ongoing; omeprazole (PRILOSEC [OMEPRAZOLE]) for reflux gastritis, chronic gastritis from an unspecified start date and ongoing; alprazolam (XANAX) for anxiety, post-traumatic stress disorder from 2009 and ongoing; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) for asthma from an unspecified start date and ongoing; ranitidine (RANITIDINE) for an unspecified indication, start and stop date were not reported.The patient previously took flu vaccine vii, olysio for hepatitis c and experienced histamine level increased, lyrica and experienced weight increased. Ten minutes after the vaccine was administered the patient experienced generalized aching on 01Mar2021 at 13:55 with outcome of not recovered. After twenty minutes she developed a pretty severe headache on 01Mar2021 14:05 with outcome of recovering. After 30 minutes she stared to feel nausea on 01Mar2021 at 14:15 with outcome of recovered. She stated that when she stood up to leave felt like started to feel dizzy on 01Mar2021 with outcome of unknown, and felt like she was going to faint on 01Mar2021 with outcome of unknown, her vision blurred on 01Mar2021 with outcome of not recovered and she had trouble getting into the elevator. She also experienced a loss of appetite on 01Mar2021 with outcome of recovering. The patient continued to describe her experiences noting that "things changed daily" and mentioning that she experienced fibromyalgia flare up on 01Mar2021 with outcome of not recovered, no energy been very tired on 01Mar2021 with outcome of not recovered , no energy been very tired on 01Mar2021 with outcome of not recovered , couldn't get warm- very cold, her skin was very cold on 02Mar2021 01:30 with outcome of not recovered, flu-like symptoms on 01Mar2021 with outcome of recovering, hands feel warm to touch, but she still feels cold on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, sick in Mar2021 with outcome of unknown, her bones hurt in Mar2021 with outcome of unknown, her muscles hurt in Mar2021 with outcome of unknown, wheezing on an unspecified date in Mar2021 with outcome of unknown. Lab tests and procedures included cardiac output: over 50 percent, echocardiogram: her heart was good and clear, electroencephalogram with unknown results, magnetic resonance imaging with unknown results, all on unknown dates. Therapeutic measures were taken as a result of pretty severe headache; Sender's Comments: Based on the available information, the company considers that a causal relationship between generalized aching, severe headache, feel dizzy, going to faint, vision blurred, no energy been very tired, very cold, her skin was very cold, wheezing and bnt162b2 vaccine cannot be excluded due to plausible temporal association. The Company considers the reported event fibromyalgia flare up is unrelated to bnt162b2 vaccine but more likely due to underlying medical history of ongoing fibromyalgia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-03-29 tingling, involuntary muscle movements, numbness Initially--fatigue, fever, muscle aches. On day 4--parethesia and numbness causing imbalance on le... Read more
Initially--fatigue, fever, muscle aches. On day 4--parethesia and numbness causing imbalance on left side. lasted a brief time--less than 20 minute. Day 5 paresthesia and numbness on waking up on left side, increased in intensity during the day. Difficulty walking and using left side. Muscle control lacking and balance very poor. The intensity of this fluctuates--there are days that improvement seems to be happening and then very bad days. Admitted to the hospital on Wednesday, March 24, 2021, via the ER. MRI, CAT scan, heart monitor, --these did not show evidence of a stroke as suspected at the time. The neurological symptoms persist, at times including numbing on the left side of my face.
67 2021-03-31 pain in extremity, feeling hot inflammation; sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was r... Read more
inflammation; sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was really hot like a boil; sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was really hot like a boil; skin is dry from being inflamed; skin is dry from being inflamed; skin reaction red rash under both armpits; skin reaction red rash under both armpits; swelling in arm; soreness in arm; This is a spontaneous report received from a contactable nurse (patient). A 67-year-old female nurse reported for herself that she had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EM9809), via an unspecified route of administration in left arm on 09feb2021 14:00 at single dose for prevent the covid virus. Medical history included female surgery. Concomitant medication included colecalciferol (D3) at 3000 iU, daily, macrogol 3350 (MIRALAX) at alternate day for female surgery. The patient's had a past drug included included Zyrtec for seasonal allergies like dust and stated that she took no Zyrtec at all for either shots. The patient stated that she takes macrogol regularly every other day for the last 5 years for a female surgery and her female surgeon says she needs it to stay out, but the ingredient is also in macrogol. The patient reported that she had both vaccinations and had the rosy arm pits red rash and sometimes she get a reaction in my ears if it flares up and gets hot. For 5 weeks she was taking children's Benadryl. The patient had a quicker reaction with the second dose and still had some lingering effects from the first dose when I got the second. On 09Feb2021 she had swelling in arm after shot and has been using a cool cloth on it and was better by the next day. The patient reported she still feels it though and it has been five weeks and she tries to turn arm and can still feel it but it is not bad. The patient stated a day later she had her first skin reaction which was a red rash under both armpits. The patient stated she waited because she wanted to see what reactions she would have with second dose. The reaction from first dose happened for three weeks. It was reported that she had been taking liquid Benadryl everyday sometimes during night and also cold wet compresses in armpits has helped with inflammation. The patient stated she called primary care doctor and talked to nurse to see if she should try some other medication before second shot and the nurse recommended, she should not get second shot that she should see an allergist. The patient stated she asked the nurse about the quality of first and second shot working together if she had waited and not got second shot and the nurse told her she would have to come back at least four days after the second shot was due or it would not work together. The patient stated she went ahead and got the vaccine and it has not been life threatening as of now. The patient stated she saw an allergist three days after second shot. The patient had rosy red inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly bilateral armpit and then sometimes ears would get hot. The patient then stated she would take Benadryl. The patient stated her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient took the Allegra medication on Sunday morning and that it worked for her for about 12 hours and she knew she could not take any more Allegra but the Benadryl seemed to help. The patient reported her Allergist felt she made the right decision since her events are not life-threatening since it is not respiratory. It was reported that the Allergist saw her armpits agreed the children Benadryl was working and that she should stick with that. The patient then stated but it is not going away been like this the whole time since 02Mar2021 and still having a reaction in her armpits. The patient stated after the second shot the flare up was quicker because first shot was already in system still. The patient stated it is not a flare up like when someone cannot eat seafood and stuff like that. The patient stated she wanted to wait for second dose before contacting Pfizer to see what would happen. The patient stated she is really blossoming under the armpits and they are rosy, red but no blisters and her skin is dry from being inflamed all this time. The patient squeezes a rag under her armpits and that it is better during the day than at night, it is worse at night. The patient was only taking 20 mL of Benadryl in the morning and then evening before bed. It was reported that with the first shot right at the beginning she had to take Benadryl in the middle of the night as well but got to where she was taking it 12 hours apart before second dose. It was reported that she hopes she is not having to walk around with compresses in the summer as it is easier when it is cold and that she hopes this fazes. It was reported that she was noticing since she had not taken a shower or hot bath this morning that she had rosy red cheeks like a rosy red U on her face. The patient did not experience any swelling or soreness with second shot. The patient stated she experienced ears would get warm feeling very hot only six times and it was usually at night or in the morning from the second shot. The patient stated every once in a it while flare up from the first. The patient stated the hurt was always in the center of armpit not in the armpit. Caller stated thank goodness she can still shave. The patient stated past couple of days her skin has been dry. The patient stated she has used hand cream but is afraid to put anything else on it because of reaction. and she will probably put cream on it so it does not crack, it is very dry and it has not been dry like this. The patient stated she has been putting water on at night which could have dried it out. The patient stated soreness in arm happened right after first shot. The patient stated she did not want to double up on Allegra as she was not sure what the reaction would be. The patient stated the medical ingredient was Fexofenadine HCL 180 mg antihistamine and stated she only took one pill as it did not work. The patient was taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. The patient stated she had the Pneumonia shot and never had swelling. The patient was not recovered from soreness in arm, skin reaction red rash under both armpits, skin is dry from being inflamed and recovering from inflammation, outcome was unknown for sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was really hot like a boil and swelling in arm. The reporter assessed events are related to drug. The outcome of the event inflammation was recovering, ear discomfort, Feeling hot, swelling in arm was unknown and rest of the events was not recovered.
67 2021-04-01 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old fema... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included hypertension, type 2 diabetes mellitus, kidney disease, and known allergies to Penicillin and Sulfa drugs. Concomitant medications included amlodipine besylate (AMLODIPINE BESYLATE) and dulaglutide (TRULICITY); both taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 (13:00 Friday), the patient experience left side of face became numb and droopy with droopy eye lid and numb lips. The patient sought medical care; stroke was ruled out. The diagnosis was Bell's Palsy. Valacyclovir hcl 1-gram tab was prescribed. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. The event was considered serious (seriousness criteria: important medical event). Information about lot and batch number was requested.
67 2021-04-01 bell's palsy Bell's palsy; got second dose early on 11Mar2021, it was originally scheduled for 14Mar2021; got sec... Read more
Bell's palsy; got second dose early on 11Mar2021, it was originally scheduled for 14Mar2021; got second dose early on 11Mar2021, it was originally scheduled for 14Mar2021; This is a spontaneous report from a contactable consumer (patient's daughter). A 67-year-old female patient (mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the left arm on 11Mar2021 at 19:20 (batch/lot number: EN6207) as a single dose for COVID-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medications included ongoing high cholesterol meds (unspecified). The patient had no vaccinations within four weeks prior to the first administration date of the suspect vaccine. The consumer was calling on behalf of her mother who doesn't speak English who got the Pfizer COVID-19 vaccine second dose on the 11Mar2021 then was admitted to the hospital on 17Mar2021 with a diagnosis of Bell's palsy. She said that her mother's vaccine card was handwritten and does not provide NDC/EXP. She said that the LOT for her mother's first dose was EN6203, which she got on 21Feb2021 at 02:30PM. She said that the second dose for her mother was injected at 07:20PM 11Mar2021. She said that her mother was admitted to the hospital at 03:00PM 17Mar2021 after she took her to the emergency room. She said her mother was prescribed steroids and antivirals. She said for diagnosis at first they did CAT scan, X-ray, MRI, and an echo to verify not a stroke, which those were negative for stroke. She said that her mother was discharged from the hospital yesterday on the 18th at about 03:15PM. She said her mother was currently feeling about the same right now, she has no issues with motor skills, it was primarily facial droopage. She clarified that the steroids her mother was prescribed for treatment was Prednisone 20 mg, that came in a pharmacy bottle that does not provide NDC/LOT/EXP on the label. She said the label says discard by 18Mar2022. She said her mother was prescribed to take Prednisone 20 mg tabs, 3 tabs by mouth in the morning for 6 days. She says for the antivirals for treatment, her mother was prescribed Valacyclovir HCl 1 gm tab twice a day morning and night for 7 days. She said this was also dispensed in a pharmacy bottle without NDC/LOT/EXP provided on pharmacy label. She said her mother has not had any other recent vaccinations or started any new medications. She asked if the purpose of calling was just to give information about what had happened, since the hospital said to report it to Pfizer, and she was not sure exactly why. She said her mother was on insurance plan and she doesn't know if there was any assistance with that for hospital bills, but they didn't say if there was anything towards that. She said she wonders if there was information with medical bill assistance for this being kind of diagnosed or someone to notify. She said she would also like to know if this could be because her mother's second dose was early, it was originally scheduled for 14Mar2021, but due to the weather there, the blizzard, they had her mother come in early to get shot. The seriousness criteria of the event Bell's palsy was hospitalization, duration of stay was overnight: 17Mar2021 to 18Mar2021. The outcome of the event Bell's palsy was not recovered.
67 2021-04-01 pain in extremity microemboli.; some splinter hemorrhages; erythema and tenderness progressively over weeks of all her... Read more
microemboli.; some splinter hemorrhages; erythema and tenderness progressively over weeks of all her finger pads; erythema and tenderness progressively over weeks of all her finger pads; crop is elevated; This is a spontaneous report from a contactable physician. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in left arm on 25Feb2021 12:00 (Lot number was not reported) as single dose for covid-19 immunization at age 67 years old. The vaccine was given in a Pharmacy or Drug Store. Medical history included APLA, hypothyroid, obesity, and allergies. The patient was not pregnant. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included warfarin sodium (COUMADIN); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC); all taken for unspecified indications, start and stop date were not reported. No other vaccines administered in four weeks. The patient previously took erythromycin and PCP and experienced allergies to both. The patient previously received the first dose of bnt162b2 intramuscular in left arm on 04Feb2021 12:00 PM (at age 67 years old) for covid-19 immunisation. The patient with APLA on coumadin 1-2 days after receiving the vaccine developed erythema and tenderness progressively over weeks of all her finger pads, crop is elevated (as reported) and some splinter hemorrhages suspect microemboli. Just to left hand, systemically well. The adverse evemts occurred on 26Feb2021 12:00 PM. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment was given to patient for the events. The patient had not recovered from the events. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
67 2021-04-03 feeling hot Skin reaction red rash under both armpits: Caller stated the event started the first day after the f... Read more
Skin reaction red rash under both armpits: Caller stated the event started the first day after the first shot then still having reaction from the second shot; Skin reaction red rash under both armpits; Ears would get warm feeling very hot; after the second shot the flare up was quicker; skin is dry from being inflamed; skin is dry from being inflamed; blossoming under the armpits and they are rosy red but no blisters; hurt was always in the center of armpit not in the armpit; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:00 (Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 (lot number: EM9809) on 09Feb2021 in the bicep left arm upper muscle for COVID-19 immunization. Medical history included surgery from an unknown date and unknown if ongoing. Concomitant medication included vitamin D3 taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took Miralax. The patient previously had first dose of BNT162B2 (lot number: EM9809) on 09Feb2021 in the bicep left arm upper muscle for COVID-19 immunization and Pneumonia shot and never had swelling. The patient had rosy arm pits red rash and sometimes get a reaction in ears, if it flares up and gets hot. The patient stated, "For 5 weeks I've been taking children's Benadryl. I had a quicker reaction with the second dose than I did the first one but I still had some lingering effects from the first dose when I got the second. How long do these side effects usually last?" The patient had second COVID 19 vaccine and also had first one. The first dose was on 09Feb21 and she had swelling in arm after shot and has been using a cool cloth on it and was better by the next day. The patient still feels it though and it has been five weeks. The patient tries to turn arm and can still feel it but it was not bad. A day later she had her first skin reaction which was a red rash under both armpits. The patient waited because she wanted to see what reactions she would have with second dose. The reaction from first dose happened for three weeks. The patient has been taking liquid Benadryl everyday sometimes during night and also cold wet compresses in armpits has helped with inflammation. The primary care doctor and talked to the patient to see if she should try some other medication before second shot and the nurse recommended she should not get second shot that she should see an allergist. The patient got second shot and talked to nurse there. The nurse told the patient she would have to come back at least four days after the second shot was due or it would not work together. The patient went ahead and got the vaccine and it has not been life threatening as of now. The patient saw an allergist three days after second shot. The patient had rosy red inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly bilateral armpit and then sometimes ears would get hot. The patient would take Benadryl. The physician told the patient to try to take Allegra 24 hours but the patient stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient took the Allegra medication on Sunday morning and that it worked for her for about 12 hours and she knew she could not take any more Allegra but the Benadryl seemed to help. The allergist felt she made the right decision since her events are not life-threatening since it is not respiratory. The allergist saw her armpits agreed the children Benadryl was working and that she should stick with that. The patient stated, it is not going away been like this the whole time since 02Mar2021 and still having a reaction in her armpits. The patient stated after the second shot the flare up was quicker because first shot was already in system still. It was not a flare up like when someone can not eat seafood and stuff like that. The patient still has a rosy armpit. The patient has not seen her doctor since last year when she had a physical. The patient would inform her doctor about these events. The patient stated she is really blossoming under the armpits and they are rosy red but no blisters and her skin is dry from being inflamed all this time. She squeezes a rag under her armpits and that it is better during the day than at night, it is worse at night. The patient was only taking 20 mL of Benadryl in the morning and then evening before bed. The patient stated, "the first shot right at the beginning she had to take Benadryl in the middle of the night as well but got to where she was taking it 12 hours apart before second dose." The patient hopes she is not having to walk around with compresses in the summer as it is easier when it is cold and that she hopes this fazes. The patient was noticing since she had not taken a shower or hot bath this morning that she had rosy red cheeks like a rosy red U on her face. The second shot she asked the nurse to give in her back upper part of bicep in arm muscle since it was a better location and it did not swell up and it did not hurt. Caller stated the nurse the first time gave the shot like when you see people getting shots on tv they put it really high up in muscle. The patient considered the event as medically significant and that it is ongoing and has worsened. The hurt was always in the center of armpit not in the armpit. The past couple of days her skin has been dry. She has used hand cream but is afraid to put anything else on it because of reaction. Just annoying. The patient will probably put cream on it so it does not crack, it is very dry and it has not been dry like this. The patient has been putting water on at night which could have dried it out. Some days is worse than others more red. This is persisting. Soreness in arm happened right after first shot. The shot was given in the proper way but seemed like more of a reaction. The second shot is much better and that she does not feel it at all. The patient can still feel where the vaccine went in left arm. It was annoying but it does not keep her from moving her arm and it has been five weeks. Since it is not going away it is serious. The patient was not taking Benadryl in middle of day like before but it is itchy so she is going to go out in the cold and work in yard. Before first week or two she would use cool compresses all day and take Benadryl during day and then at night it petered out. The patient was hoping it will fade out eventually. The patient did not want to double up on Allegra as she is not sure what the reaction would be. The medical ingredient was Fexofenadine HCL 180mg antihistamine. The patient only took one pill as it did not work. 24 hour Allegra, 180mg antihistamine 15 tablets per box. The patient was taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. The patient usually takes Zyrtec for seasonal allergies like dust. She took no Zyrtec at all for either shots. She felt the Benadryl worked better and quicker. The patient was at the Allergist she asked what is in this vaccine like what chemical. She looked up the ingredients but did not understand. Her friend told her Polyethylene glycol was in both the Pfizer and Moderna vaccine. The patient had rosy red, inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly her bilateral armpits and then sometimes ears would get hot. The patient stated her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient stated she took the Allegra medication on Sunday morning and that it worked for about 12 hours and she knew she could not take any more Allegra. The patient stated the medical ingredient was Fexofenadine HCL 180mg antihistamine. The patient stated she only took one pill as it did not work. Sample of the product was available to be returned. The packaging was sealed and intact. The outcome of the event "Ears would get warm feeling very hot" and "after the second shot the flare up was quicker" was unknown. The outcome of the rest of the events was not recovered.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of events rash and erythematous rash (allergy context) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
67 2021-04-06 facial pain, numbness Rash in her mouth/break out on her lips and her ear; Rash in her mouth/break out on her lips and her... Read more
Rash in her mouth/break out on her lips and her ear; Rash in her mouth/break out on her lips and her ear; Shingles; Pain; Ramsay-Hunt syndrome; Loss of hearing; Itchy on the left side of the face; Blisters on face, temple, ear; Left side of her face is scorched bright red and painful; Left side of her face is scorched bright red and painful; Numbness; no feeling in her mouth on the left, cheek, temple; Numbness; no feeling in her mouth on the left, cheek, temple; Blisters in her mouth; Pain, teeth started hurting went to her temple; Pain, teeth started hurting went to her temple; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 20Feb2021 (09:30) as a single dose, with route of administration unspecified, for COVID -19 immunization at the pharmacy/drug store (not a military facility). Medical history included shoulder surgery in Aug2020; ongoing abnormal blood pressure; ongoing heart disorder; and was in a pacemaker and defibrillator. Concomitant medications included carvedilol for abnormal blood pressure from 2012 and ongoing; losartan for heart disorder from 2012 and ongoing; and furosemide from 2017 and ongoing. On 05Mar2021, the patient had Ramsay-Hunt syndrome and loss of hearing. On 21Feb2021, the patient had pain/teeth started hurting and went to her temple. On 22Feb2021, the patient had blisters in the mouth; left side of the face was scorched bright red and painful; and numbness/no feeling in the mouth on the left, cheek and temple. On 23Feb2021, the patient had blisters on face, temple and ear. On 25Feb2021, the patient was itchy on the left side of the face. On an unspecified date, the patient had rash in her mouth/broke out on her lips and ear; shingles; and pain. The events, 'pain/teeth started hurting and went to her temple', 'blisters in the mouth', 'blisters on face, temple and ear' and 'pain', had resulted into physician's office visit. The patient's ENT had the patient put on treatment with valaciclovir (VALTREX) and prednisolone for the 'blisters in the mouth', 'blisters on face, temple and ear'; treatment for 'pain/teeth started hurting and went to her temple', 'left side of the face was scorched bright red and painful', 'itchy on the left side of the face', 'rash in her mouth/broke out on her lips and ear', 'shingles' and 'pain'; and unspecified ear drops for 'loss of hearing'. The outcome of the events was not recovered for 'Ramsay-Hunt syndrome', 'loss of hearing', 'pain/teeth started hurting and went to her temple', 'left side of the face was scorched bright red and painful', 'numbness/no feeling in the mouth on the left, cheek and temple' and 'itchy on the left side of the face'; was recovered on 04Mar2021 for 'blisters in the mouth' and 'blisters on face, temple and ear'; and was unknown for 'rash in her mouth/broke out on her lips and ear' and 'pain'. The patient had received the second dose of vaccination on 20Mar2021. Information about batch/lot number has been requested.
67 2021-04-12 one side paralysis problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's ... Read more
problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; dragging her feet; trouble standing up; feels like a stroke in her leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), intramuscular, administered in the left arm on 24Mar2021 at 12:30 as a single dose for COVID-19 immunization. Medical history included stroke on Dec2015 and Feb2016 and ongoing left side, having weakness since she had a stroke. The patient's mother had a really bad stroke on an unspecified date in her 80's. The patient's concomitant medications were not reported. The patient previously received the first dose of BNt162B2 (lot number: EN6208) on 03Mar2021 for COVID-19 immunization and had a sore right arm. It was reported that on 26Mar2021, the patient was dragging her feet and having trouble standing up. This occurred after her second shot. She has had a problem with her left side, having weakness since she had a stroke at the age 62 years. She worked through it and it was fine. But when she took the 2nd shot, it's been bothering her through the weekend. Her left side weakness worsened. She described the feeling like the stroke. Her doctor said when she gets sick, it could mimic her stroke symptoms. She added it is worse in the morning when she tries to get up. The patient added that her leg is affected, and feels like a stroke in her leg on Mar2021. She had no treatment for her experience and doesn't know if there is a treatment for what she is experiencing. The outcome of the events was unknown. Information on the lot/batch number has been requested.
67 2021-04-17 weakness Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell... Read more
Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; busted her lip and it was bleeding real bad; Weakness/ feeling weak; Feel weak in her arms and legs; Sweating profusely; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Foggy Brain; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) intramuscularly, administered in the left arm on 11Mar2021 (batch/lot number: EN6205) at 67 years old as a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Pharmacy/ drugstore. The patient's medical history included compromised immune status; respiratory illness, genetic /chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; asthma diagnosed since childhood; diagnosed allergies, allergies (seasonal and food); food allergies included gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, broccoli, cauliflower, cabbage, brussel sprouts, asparagus, all "percifirous"/ cruciferous vegetables; she also has allergies to cats, pollen, trees, grass, ragweed, mold, mildew, and dust; and allergies to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, and Clindamycin (patient does not have a manufacturer, lot or expiration to any of these medications). The patient had no family medical history. Concomitant medications included unspecified prescription medications for years which she did not feel they were relevant. On 11Mar2021, the patient experienced "weakness/ feeling weak" (weakness), "feel weak in her arms and legs" (weakness of limbs), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (faint), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (fall), "busted her lip and it was bleeding real bad" (bleeding lips), sweating profusely (excess sweating), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Flu-like symptoms), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Joint pain), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (muscle pain), and foggy brain (foggy feeling in head). On 12Mar2021, the patient experienced headaches, chills, itching rash on arms, back, neck and chest (itchy rash). On13Mar2021, the patient experienced blurred vision. It was reported that after the first shot, on 11Mar2021, patient experienced weakness, then she got home and she fainted, fell, and busted her lip and it was bleeding real bad. Then she began sweating profusely. She started feeling weak 30 minutes after getting the shot. Someone took her there because she would not have been able to drive. They brought her home and she was in the kitchen. While over the sink, she started to feel weak in her arms and legs. Before she could tell her husband that she was feeling weak, she dropped to the floor and everything was turning black. She fell face first and busted her lip and it was bleeding real bad. The weakness gradually started getting a little better on 30Mar2021. She is having to walk with a cane now because of the weakness. She was not using a cane before. Two days later on 13Mar2021, she was in the kitchen again and she felt that feeling coming and her husband was able to grab her and sit her down and she did not faint but she could tell it was coming. Patient also reported that from 12Mar2021, she is getting headaches every day off and on and in different spots of the head. Sometimes it is in the forehead, top, side and back. For about a good week, she had chills and it tapered off after the first dose. Also, on 12Mar2021, she experienced itching rash on arms, back, neck and chest. They were fine bumps and they just itch. The patient was recovering from the events faint, fall, bleeding lips, excess sweating, and itchy rash; and has not recovered from the events weakness, weakness of limbs, flu-like symptoms, joint pain, muscle pain, foggy feeling in head, headache, chills, and blurred vision. Follow-up attempts are completed. No further information is expected.
67 2021-04-17 pain in extremity Bottom of heel hurt/she is not experiencing any arm pain. It is in her ankle and feet; discoloration... Read more
Bottom of heel hurt/she is not experiencing any arm pain. It is in her ankle and feet; discoloration inside of the left ankle and bottom of heel; she is not experiencing any arm pain. It is in her ankle and feet; Hallucinations; ankle swollen; This is a spontaneous report received from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Mar2021 10:00 (Batch/Lot Number: EN6208; Expiration Date: Jun2021) as a single dose for COVID-19 immunization. Patient received the first dose on 04Mar2021 10:00 in the left arm (Batch/lot number: EN6200, Expiration Date: Jun2021) and she had headaches, arm ache, and hallucinations which would go and come. When she would try to sleep, the hallucinations would go and come but then the hallucinations stopped prior to getting the second dose. Headaches started a couple of days after the first dose probably started the next day and started coming and going. This stopped prior to the second dose probably a week or week in a half maybe two weeks before getting second dose. The headache only lasted about half a day, it wasn't that bad. She recovered completely. Arm sore, red only happened with the first dose as her arm did not hurt at all after the second. This started the next day or even the same day but she kept it comfortable and probably stopped within the first week and it did not come back either. She has recovered completely. Sharp pain through arm go and come. This started after the first dose so in that week or week in a half area and it stopped about at least a week before the second dose somewhere in that period of time. She has recovered completely. Hallucination: she was laying down at night and something would come across her head that she was not thinking. It started right after the first dose probably first, second, or third night but it stopped like all the rest of it in same period of time. She had recovered completely prior to getting the second dose. Medical history included arthritis and diabetic. The patient's concomitant medications were not reported. Patient had the flu vaccination for the first time in Oct2020 or Nov2020 and did have a headache and she has never taken the flu vaccine before. The patient had side effects from the vaccine she received on 25Mar2021. Her ankle was swollen on 28Mar2021 but that went down on 30Mar2021. This has left discoloration inside of her left ankle and bottom of her heel and it was sore from 30Mar2021 and ongoing. It was not red, tender, or bruised. The bottom of her heel hurt when she put pressure on it and walked on 31Mar2021. It was ongoing but was off and on and it has worsened. She had her feet up on the bed. As treatment, patient used heat, ice, and has been elevating her feet. She called her doctor and doctor told her to keep doing it since she has been doing it since Monday. With the second shot, she is not experiencing any arm pain. It is in her ankle and feet and then the hallucinations still go and come and she sees images that come still but do not stay they just go and come. After the second dose, she had this last night and the night before last, she would not be thinking it but it would appear in her mind and she was wondering why it was doing that but she thought maybe a week or two it will stop and come down. This started on 28Mar2021, Sunday after the second dose and is still going on. Outcome of the event ankle swollen was recovered on 30Mar2021, of the event arthralgia was unknown, and of the other events was not recovered.
67 2021-04-17 pain in extremity Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous rep... Read more
Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 04Mar2021 10:00 (Batch/Lot Number: EN6200; Expiration Date: Jun2021) as SINGLE DOSE for COVID-19 immunization at the doctor'ss office. Medical history included arthritis and was diabetic. Concomitant medications were not reported. It was reported that right after the first dose probably first, second, or third night in Mar2021 the patient had hallucinations. The patient also had headaches and sharp pain through arm/arm sore a couple of days after the first dose (probably started the next day or even the same day) which come and go. The patient recovered from the events in Mar2021 (a week or week in a half maybe two weeks before getting second dose). Follow-up attempts are completed. No further information is expected.
67 2021-04-17 bell's palsy On Saturday, 27Mar, it was Bell's Palsy paralysis of the right side of my face.; By Tuesday, 23Mar, ... Read more
On Saturday, 27Mar, it was Bell's Palsy paralysis of the right side of my face.; By Tuesday, 23Mar, I had an earache and sore throat.; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 67-year-old female patient (who was not pregnant at the time of vaccination), received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6204 and expiry date was not provided), via an intramuscular route of administration, in left arm on 20Mar2021, at 14:30 as single dose for COVID-19 immunisation. Patient's medical history included breast cancer in 2009, gall bladder disorder in 2020, tonsillectomy in 1965, hysterectomy in 1986 and patient had known allergies to Latex, nail polish remover and sensitivity to fragrances. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number: EN6198, and expiry date was not provided), via an intramuscular route of administration in left arm on 27Feb2021, at 12:30 PM as single dose for COVID-19 immunisation. No other vaccination received in past four weeks and no other medications in past two weeks of vaccination. Patient stated that by Tuesday, 23Mar2021 at 05:00, she had an earache and sore throat. On Saturday, 27Mar2021, it was Bell's Palsy paralysis of the right side of her face. As a result, the patient had to visit Emergency room/department or urgent care and physician office visit. The patient has been tested for COVID, post vaccination, on 27March 2021, which resulted as negative. The patient was treated for the adverse events with Prednisone and antiviral medicine. Outcome of the events was not recovered.
67 2021-04-22 pain in extremity Sharp pain in my upper arm, wrapping around to my triceps, into my left trapezius and up into the le... Read more
Sharp pain in my upper arm, wrapping around to my triceps, into my left trapezius and up into the left side of my neck. At about that same time, I developed pain in my left wrist and in the pinky and ring fingers of my left hand. Pain has continued for more than two months now despite regular stretching of the affected areas, use of a wrist brace, and applications of Icy Hot patches to my arm and upper back.
67 2021-04-24 weakness Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; inject... Read more
Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; injection site redness; severe allergic reactions; slight dizziness; severe headache; nausea; weak; tired; feverish; sweat; had pain at the Pfizer Covid 19 Vaccine injection site; right arm started to swell; chills; extreme muscle pain; certainly extreme and joint pain; Heart beat seemed to speed up; Has not been able to walk or move body in normal fashion; This is a spontaneous report from a contactable consumer (patient herself) A 67-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) a week ago via an unspecified route of administration on 02Apr2021 at 13:45 hrs on the right upper arm as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.When caller was 18 they required a booster for Small pox and caller received the small pox booster on the leg in the same site where it was given at age 5. Caller's leg swelled up to 5 times the normal size, at the time caller was 18 years old.Took a long time for swelling to go away, a couple weeks. Caller requires it hindered sports activities during this time. On 02Apr2021, the patient started reported slight dizziness, severe headache, Shakiness, nausea, weakness, tiredness, have been feverish, pain at the injection site and stated that her right arm started to swell. The patient stated that through out the night of 02Apr2021, she had extreme muscle pain, certainly extreme and joint pain that was also extreme and heart beat seemed to speed up within the first hour and by the end of the hour. On 03Apr2021, the patient stated that her muscles and nerves seemed to be locking up like almost paralyzed. The patient described the events she experienced slight dizziness and didn't worry because it wasn't major and caller was driving herself and with in an hour the dizziness got worse. Caller had severe headache and had to drive home a significant distance and the time the caller got home, she reports being shaky, dizzy, had headache, nausea, was weak and tired and must have been feverish. Caller reports she must have been feverish because she was drenched in sweat by the time she got home and it was a 2 hour drive home from the vaccine administering facility. Caller had pain at the Pfizer Covid 19 Vaccine injection site, and caller's right arm started to swell.Caller clarified that the injection site was in the right upper arm, doesn't know what the muscle is called. Caller says she couldn't see if her arm was getting red, caller has some discs out in her neck and is unable to look at the arm. Caller could feel the injection site on her right arm was swollen and swelling. Caller reports fever was gone and fever got replaced with chills later on. Caller reports there was progression of the symptoms after the first hour. Caller states the information provided thus far was the first hour of her experience and through the night a lot of other things changed and added.Through the night caller had extreme muscle pain, certainly extreme and joint pain that was also extreme. Muscles and nerves seemed to be locking up like almost paralyzed: By the next morning, after caller had the Pfizer Covid 19 Vaccination, states she was not a doctor but all of her muscles and nerves seemed to be locking up like caller was almost paralyzed. Caller reports she couldn't move, couldn't get out of bed. It took a long time to get caller's fingers and toes moving and the rest of the body, but fingers and toes were the first ones. Caller was able to kind of release from muscle cramping. Whatever was going on, caller says can't tell exactly what was going on, does not have a Doctor in the home. States the information given should cover that part of the experience. Through the night had extreme muscle pain, certainly extreme and joint pain that was also extreme: Reports since the morning after receiving the Pfizer Covid 19 Vaccine, caller has had continued muscle pain, although not as extreme, its pretty extreme, and join pain. The patient has not been able to walk or move body in normal fashion. The patient stated that she had every side effect listed on the fact sheet at the top minus the swollen lymph nodes and injection site redness and she had two of the side effects listed under the severe allergic reactions. The patient wanted to know whether it is safe to receive the second dose of the vaccine. The patient lives in an isolated area where all through COVID-19 she tried to get information from the local medical clinics and they did not seem to stay informed. Caller states she has a doctor's appointment, and she will let them know the side effects she experienced after the first dose but she is not confident in the recommendations they might provide. Patient was given a list of side effects to look for, ones they were assuming, doesn't know if the hand out was published by Pfizer or not.The hand out listed emergency kind of side effects people were experiencing.Caller reports they are over age 65 range and knew a lot of people before her who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Caller was expecting the same reaction, caller was told by the Doctor she was in pretty good shape. Caller reports she had most all of the reactions except anaphylactic reaction of not breathing after receiving first dose Pfizer Covid 19 Vaccine. Caller is nervous about going for the second round of the Pfizer Covid Vaccine, is not sure how to proceed and would like that information. The case was assessed as serious medically significant for the event paralysis. It was reported that patient took Aspirin as treatment medication for pain. The outcome of the events was resolved for fever and nausea, resolving for swelling arm, unknown for swollen lymph nodes, Chills , Vaccination site pain, injection site redness, severe allergic reactions, sweat, shaky feelings, heartbeat increased, movement disorder and not resolved for all other events.
67 2021-04-24 pain in extremity blood clot; Right leg swelled and achy; Right leg swelled and achy; This is a spontaneous report fro... Read more
blood clot; Right leg swelled and achy; Right leg swelled and achy; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534),dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included ongoing Beta thalassemias. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated she has never had a problem with vaccinations, and she gets the flu vaccine every year. The patient reported that after the first injection coincidentally she did develop a blood clot in her lower leg. She thinks that it was due to a plane ride, but she has never had a blood clot before the injection. She added that she had the first dose on 16Mar2021 and developed a clot in a week. She further clarified that she got her first injection on 16Mar2021 and realized when she went on a flight, which is not that far she developed that clot and was having problems shortly after flight home on 24Mar2021 where her leg swelled up and she is on blood thinners since she went to the emergency room. She added that she developed the clot sometime between that flight and 02Apr2021. She had a doppler study on an unspecified date and it showed a blood clot. She stated that the outcome was she does not have the blood clot (as reported) but she will be on blood thinners and she needs to follow up on her scan to see if the clot issue is resolved but she will not have a doppler scan for another month or two and the blood thinner she is taking is Xarelto. She also stated that her right leg swelled up and it felt like a log. She reported it felt achy and swollen quite a bit from knee down and her leg was achy. It started between 24Mar2021 and by time she went to the emergency room she was not getting better. She had her symptoms for a week and toward the end of the week she thought she had a blood clot since it was not getting better it just got worse. She added that right now it is not swollen but she has been supine, and she does believe that it is better. The outcome of events was recovering. (As reported "outcome is unknown but pretty sure it has improved because of the blood thinners"./She stated she does not think it has resolved because it takes time for clots to resolve./She added that right now it is not swollen but she has been supine, and she does believe that it is better.) The reporter stated for the seriousness criteria for event blood clot: she believes as a nurse that any blood clot is extremely dangerous, and she was not hospitalized but obviously a blood clot is serious, and she could have ended up with pulmonary embolism. The seriousness for events right leg swelled and achy was reported as medically disabling. Causality assessment: Patient stated for the blood clot she has doubts if it was related to the vaccine but is it something that should be known about; for the leg swelling and achy she has doubts but it could have been the plane ride.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is unlikely related to the suspected drug. The plane ride may provide an explanation for the events. The case will be reassessed if additional information becomes available.
67 2021-04-24 feeling cold, muscle spasms cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in swe... Read more
cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in sweats; She is still cold/She is freezing cold; She is loosing her hair. clumps of hair falling out.; sinus headache; had issues with her thyroid; sinusitis like when she had COVID; palpitation; nausea; feeling achy like you have a flu/ aches and pain; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in arm left on 26Mar2021 15:00 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included atrial fibrillation on an unknown date. Caller added she takes medication for Atrial Fibrillation. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache since she was diagnosed with Covid. Caller had a funny sensation in her sinuses after the injection. It was a weird feeling, just like when she had Covid. She had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. She had a lot of allergies. The patient's concomitant medications were not reported. The patient experienced headache on 26Mar2021 with outcome of recovered with sequelae on 27Mar2021, achy, chills, fever, nausea on 27Mar2021 with outcome of recovered with sequelae on 29Mar2021, palpitation, sinusitis like when she had covid, cramps, stiff neck, couldn't move her neck, it was very painful, she was breaking out in sweats, still cold/ freezing cold, loosing her hair/ clumps of hair falling out, sinus headache and had issues with her thyroid on an unspecified date with outcome of unknown. The clinical course reported as follows: Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 26Mar2021 and scheduled to get the 2nd dose on 16Apr2021. Patient experienced headache, sinusitis like when she had COVID, nausea, feeling achy like you have a flu, fever chills, cramps ,aches and pain, palpitation. Patient had tested positive for COVID last 28Dec2020 that lasted for 6 weeks. Asking if 2nd dose will be more intense when it comes to reactions and if she can safely have the 2nd dose. She will see her cardiologist due to chest palpitations. She worked and had her first Pfizer Covid-19 vaccine 26Mar2021. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache on Friday immediately after her injection. Then was okay. On Saturday morning after waking up, she felt achy, nauseous, had a fever, chills, and a headache. On Sunday she was not feeling great. Even into Monday, she had fever and chills and felt the same as when she had Covid. Caller added she is not supposed to get sick. Caller states weighs 160 pounds, which she shouldn't be. After the shot she felt a sinus headache. Funny sensation in her sinus's just like it was when she had COVID. Once she had the shot, the original headache went away along with her stiff neck. She couldn't move her neck, it was very painful, it still happens. And she had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. Caller had lasting effects from Covid, but didn't know if these symptoms were related to the shot. She was breaking out in sweats. She was still cold. There was something going on. She was having her Vitamin D level and thyroid checked. She was loosing her hair, clumps of hair falling out. She had issues with her thyroid. Caller wondering if the vaccine was the cause. She was freezing cold. She hadheart palpitations and was seeing her Cardiologist next Thursday. Caller received the vaccine because she had Covid and didn't want to get it again. She was pretty sick. She worked around people and didn't want to be in a situation because not everyone wants to get the vaccination. Treatment of events included: She had not been to the doctor for this, she just jumped into bed and took Tylenol. The events didn't require a visit to emergency room or physician office. No follow-up attempts are needed. No further information is expected.
67 2021-04-24 numbness face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinu... Read more
face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinus infection; Shortness Of Breath; pounding in my chest/throbbing in her chest; ringing in ears; flared up some digestive issues / digestive disturbances; flared up some digestive issues / digestive disturbances; red on left side/face redness; exhausted all the time; This is spontaneous report received from contactable female consumer (patient) reported herself. A 67 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199) on 10Mar2021 17:30 at age of 67 years old at single dose in right upper arm for COVID-19 immunisation. Medical history included: last year February, she was really sick with bad sinus infection not knowing about COVID at the time. Sometime later she got these horrible digestive attacks, ended up in her stomach and esophagus, horrible attacks where she couldn't breath, she has had acid reflux in the past. digestive problems stayed with her a really long time, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. She tested in April last year, it was negative (not detectable). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No adverse events (AE) following prior vaccinations. Patient had first Pfizer covid vaccine on 10MAR2021, approximately 10 days to 14 days after the vaccine her face swelled up, numbness and red on left side, went to see my doctor, he treated her with steroid and antibiotic for sinus infection, at the same time she had some shortness of breath and pounding in my chest, and had and still have ringing in ears since then, it kind of flared up some digestive issues she had last year. If she back up to last year February, she had a bad sinus infection, went to see allergist, family doctor and ENT, all treated her for sinus' before covid testing was even a thing, they didn't think of covid testing at the time. It ended up in her stomach and esophagus, horrible attacks where she couldn't breath, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. In March2020 her husband came home with covid, after that, talking to his doctor, she brought him meals outside of the door, it occurred to her that queried if this could have been covid. She tested in April last year, it was negative (not detectable), they were still not sure if it could have been covid. She was supposed to get the second vaccine, she postponed it, the numbness and swelling of face is gone, next shot was tomorrow. Since this was a delayed reaction, typically one to three days would be a reaction to the vaccine. she didn't associate it with the vaccine, asked if it could have been from the vaccine. She wanted to make sure that she was safe to get the second one. Response: Spoke from EUA factsheet for Recipients and Caregivers: LAB-1451-4.0 Revised: 06 April 2021: Sections: who should not get the PFIZER-BIONTECH COVID-19 VACCINE and what the risks of the PFIZER-BIONTECH COVID-19 VACCINE were. Spoke from attached VR Consumer- Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BioNTech Covid 19 vaccine). Your doctor/healthcare provider is in the best position to assess and advise you as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. Patient calling about the COVID vaccine. She states that she had the first vaccine 10MAR2021, and 10 days afterwards her face swelled up. She had numbness in it and redness. She went to the doctor and the doctor thought that maybe it was a sinus infection. So she was treated for that. She states that she did have a few other symptoms. To make a long story short, she was suppose to have the last vaccine last Friday. She postponed it for a week (postponed getting the second shot for a week). She wants to know what Pfizer thinks about her getting her second vaccine and her side effects. She says that somewhere between the 10th and 14th day, after receiving the vaccine the symptoms started and that was why she did not think she had a reaction to the vaccine. She has not had anything like that before, it was sort of a delayed reaction. She states she is better now. She had a few symptoms after the face things started and the only thing that she still has now is ringing in her ears. She states it all started around the same time as her face issues, or might have started a little after that. She confirms everything but ringing in her ears have completely resolved. She states that she did have some digestive disturbances, shortness of breath, and throbbing in her chest after receiving the vaccine. She asks if she can go back a little bit to explain. She states that last FEB2020 she was really sick with bad sinus infection not knowing about COVID at the time. She went to her allergist, then her family doctor, and then an ENT. She states that it was nothing like she has ever had, it was really bad. Sometime later she got these horrible digestive attacks, she has had acid reflux in the past but it was nothing like this. In March her husband had COVID and tested positive for COVID. She decided to get tested and she tested negative. She wonders if she had COVID earlier but at that time they were not testing for COVID. Her digestive problems stayed with her a really long time, and she was still on the medications her gastrointestinal doctor put her on. They are hypersensitive esophageal medication. She states that she has been exhausted all the time. The rest of the story she has told already. She states that after the face thing happened she started getting those digestive issues again. Her friend suggested that she call Pfizer, so she is doing that. She confirms that the vaccine card does not have an expiration date, NDC, or dosing information. She states it says 0.3 ml, but she cant see a point, so she doesn't know if its just 03. She states she got the vaccine to lessen her chances of getting a severe disease, in case she ends up in the hospital. Also, to keep herself safe from other people. She states she wants the second one because husbands works with the public and she wants to be protected when he comes home. She states that she has those gastrointestinal disturbances and is on amitriptyline 10 mgs for that. She states she also takes something for her thyroid but she has no major health issues. She states that she had a endoscopy and a colonoscopy as well as blood work done but she doesn't have any of the results because they are in her Beaumont chart where she actually got the vaccine. All of this was pre-vaccine so she doesn't know how relevant it is. The patient did not require a visit to Emergency Room, but visit to Physician Office. The only thing similar had a sister who reacted to a shingles vaccine, She has no information about her sisters reaction to the vaccine. Outcome of event ringing in ears was not recovered, for others was recovered. No follow-up attempts are needed. No further information is expected.
67 2021-04-24 weakness sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot,... Read more
sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; This is a spontaneous report from a contactable Nurse (patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 (Batch/Lot Number: ER8734) as SINGLE DOSE (at the age of 67 years) for covid-19 immunisation. The patient had the first dose of BNT162B2 for COVID-19 immunisation in the left arm lot number EP7534 and the patient experienced peripheral swelling in left leg and blood clot. Medical history included ongoing thalassaemia beta Caller stated she was diagnosed with this in her later 20s or early 30s. The patient's concomitant medications were not reported. The patient experienced fever (disability) on 06Apr2021 20:00 with outcome of recovered, real achy (disability) on 06Apr2021 with outcome of recovered, terrible headache (disability) on 06Apr2021 with outcome of recovered, weak (disability) on 07Apr2021 with outcome of recovering, really thirsty (medically significant) on 07Apr2021 with outcome of recovered, tired (disability) on 07Apr2021 with outcome of recovered, sleeping for 3 days on an unspecified date with outcome of unknown, left arm hot, red, and swollen at injection site on 06Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 102, body temperature: 101.9, body temperature: 106, body temperature: 101.6. Therapeutic measures were taken as a result of fever, real achy, terrible headache, weak. Treatment: Advil. The patient is not in a study or programme. No Additional vaccines administered within last 4 weeks. Events were considered related for real achy, terrible headache, weak, really thirsty, tired, and left arm hot, red, and swollen at injection site. Follow-up attempts completed: case closed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for fever and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-04-26 weakness, feeling of body temperature change, cold sweat hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pr... Read more
hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation . Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported. The patient experienced fall on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed on 17Mar2021 with outcome of recovering , dizziness on 16Mar2021 with outcome of not recovered , sleeping a lot on 17Mar2021 with outcome of not recovered , hot and cold on an unspecified date with outcome of unknown , very ill on an unspecified date with outcome of unknown , felt horrible on an unspecified date with outcome of unknown , clammy on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy on an unspecified date with outcome of unknown. The events fall and contusion were considered Important Medical Events. The remaining events were non serious. No follow-up attempts are possible. No further information is expected.
67 2021-04-27 feeling hot Nausea; Dizzy; Face Hot; Trouble breathing/chest tightness; Trouble breathing/chest tightness; 1hr p... Read more
Nausea; Dizzy; Face Hot; Trouble breathing/chest tightness; Trouble breathing/chest tightness; 1hr pain to shot; administered in right leg; This is a spontaneous report received from a contactable hcp (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right leg on 15Mar2021 09:30 (Batch/Lot Number: EN6204) as single dose for COVID-19 immunization. Medical history included known allergy, asthma, atrial fibrillation, urticaria. Concomitant medications included cetirizine hydrochloride (ZYRTEC) as pre treated; diphenhydramine hydrochloride (BENADRYL) as pre treated. The patient previously received the first dose of BNT162B2 (Batch/Lot number: EN6200) on 20Feb2021 13:00 in left leg by injection for COVID-19 immunization. The patient experienced nausea, dizzy, face hot, trouble breathing/chest tightness, pain to shot, all on 15Mar2021. Clinical course: Pre treated u/ 50mg Benadryl and 1 Zyrtec. 1hr pain to shot. u/in 15 minutes of shot: Nausea, dizzy, face hot, trouble breathing/chest tightness, given oxygen +2 more Benadryl laid down u/ feet up, discharged 1200HR Sx resolved by next day (24hours). The outcome of the events was recovered on 16Mar2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events nausea and vaccination site pain were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events "face hot, trouble breathing/chest tightness" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
67 2021-04-28 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Lot Number: ER2613) (age at vaccination: 67-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no, and no known allergies. The patient was not pregnant. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). On 23Mar2021 13:00, the patient was tired and slept, 25Mar2021 through 31Mar2021, had Low grade fever and fatigue. On 31Mar2021, thumbs turned purple and looked bruised Went to emergency room. All fingers were turning purple and swelling, could not bend fingers. Hurt to touch anything, couldn't open containers. Spent 2 nights (31Mar2021-01Apr2021) at hospital. Infectious disease doctors both agreed it was a reaction to the Pfizer Covid shot. Also CT scan at hospital showed a small nodule in the right lung. There was no nodule in the CT scan from 09Feb2021. Saw pulmonary Dr 14Mar2021 she and her colleague also believe the nodule was from the vaccine and she need to have another CT scan early May to see if it is gone. Skin peeling off thumbs and first fingers. On 02Apr2021 fingers less purple and moving some. Saw Dr 05Apr2021 wanted pulmonary appointment as soon as possible. 03Apr2021 through 12Apr2021 afternoon the patient had fatigue. The events resulted in: Emergency room/department or urgent care. No treatment received for events. Covid test (Nasal Swab) on 31Mar2021 showed Negative result. The outcome of the events was not recovered.
68 2020-12-31 pain in extremity on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amoun... Read more
on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amount swelling R hand --I iced and took acetaminophen. By Dec 25, hand very swollen and painful with decreased ROM all fingers
68 2021-01-02 hot flush After receiving vaccine, c/o burning throat, coughing, face itching, hot flashes.
68 2021-01-04 pain in extremity arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle... Read more
arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle and joint pain; chills; low grade fever 99.7; sore throat; congestion; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 3 ug/ml) Batch/lot number: EL1284, on 29Dec2020 12:33 single dose on left arm for COVID-19 immunization. Medical history included Blood pressure high which diagnosed a long time ago, probably when she was 45 years old, though it could have been when she was 42 or 43, probably earlier, 25 years ago, so put when she was 42; hemochromatosis diagnosed about 25 years ago; Arthritis; Cluster headaches; low thyroid and she didn't take medication for this, it wasn't low enough; COVID-19 in Mar2020. Concomitant medication was none. The patient received the Pfizer covid vaccine yesterday (29Dec2020) and she called the line to report the side effects today. She said she had covid around the Easter time and donated her plasma also for antibodies. She said after getting the vaccine yesterday she was feeling worse, have a really bad headache, teeth ache, arm was hurting woke up due to that in the night, really bad headache, muscle and joint pain, chills , low grade fever 99.7 , sore throat and congestion. The patient received the vaccine through work, and was not prescribed it from a provider. She had her shot at 12:33PM yesterday (29Dec2020), after lunch. Her vaccine was given to her at the hospital where she worked, which was not a military hospital. Her side effects were that she developed a headache, also her teeth were aching, and then last night around 04:00AM in the morning she woke up with a very sore arm and worse headache. She said she also had muscle and joint pains, chills, and fever. She said now she still had a headache, and still didn't feel good. Treatment received for the events included Ibuprofen and Tylenol. Ibuprofen was clarified to being generic Ibuprofen prescription in a pharmacy bottle with EXP 3 09Mar2021 and NDC: 67877032005. She said that the strength of this medication is 600mg, and she just took one last night by mouth at about four in the morning. She says she also took Tylenol before bed, 500mg, this is the name brand product. UPC/LOT/EXP: unknown, she didn't have it with her she said it was in date and was brand new, in to go packs. She said that her teeth aching was gone, she still had her headache, muscle pain, fever, and her arm hurt. She said she did take another Tylenol a half hour ago or 45 minutes ago. Her low grade fever temperature was 99.7 degrees Fahrenheit. She had COVID-19 before, she tested positive for COVID at Easter time, this was in March, they did a PCR nasal swab. She had two positive tests and then a negative test because they had to retest her to get plasma, she had to be negative before she could get plasma. She also had an antibody test a couple months after she had COVID, that showed she had 27 antibodies. She had COVID, then a couple of weeks later she gave plasma, and then a few weeks later had the antibody test that showed she had the 27 antibodies. The outcome of teeth ache was resolved. The outcome of headache, muscle pain, fever, and her arm hurt was not resolved. The outcome of other events was unknown.
68 2021-01-07 tremor 1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight he... Read more
1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness, shakes, overall malise, chest tightness. Later that day, mild diarrhea, mikd nausea. Day 3- woke with wheezing. Symptoms all continued for next 10 days off and on. The lip, tongue seemed to get shorter and shorter in duration. Also has mouth watering. Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec. Back to urge t care day 6, Ed day 8. Day 14 abd 15 awful chills, muscke ache and shaking.
68 2021-01-07 pain in extremity Immediately sore right arm lasting approximately 1 day. Then after initial dose on the second day af... Read more
Immediately sore right arm lasting approximately 1 day. Then after initial dose on the second day after first injection, I began with chills, headache, fatigue, body aches. By the second day after initial dose, I began with mucus cough and same symptoms with chills, headache, fatigue and body aches. I took Tylenol, cold and cough medication. It is the third day after injection, symptoms same, but slightly better, still extreme fatigue and body aches and chills and I took an Proventyl inhaler as needed. Note, I do not take Proventyl inhaler on a regular basis, I just felt the need as I was beginning to have a lot of bronchial mucus. The inhaler seems to help. I am waiting it out and did not contact my family physicians. I am hoping I will feel better soon. Still taking OTC medications and Tylenol, fluids and rest.
68 2021-01-07 pain in extremity In the evening on the day of the vaccine and the following day my arm was sore and then my entire bo... Read more
In the evening on the day of the vaccine and the following day my arm was sore and then my entire body. Body was so sore that I had to take med to sleep. It is early Friday morning now and I have been so tired and hurting that I have slept most of the week (4 days). I don't often take immunizations as they kick in my rheumatic/psoriatic arthritis so badly and I hurt so badly and can't do anything. I was hoping that this immunization would be different as it's action is supposed to be different. I am still planning on getting the second shot as it is so important:especially due to my age and other conditions.
68 2021-01-07 pain in extremity Initial right arm soreness. Second day after initial dose. chills, headache, fatigue, stuffy nose, c... Read more
Initial right arm soreness. Second day after initial dose. chills, headache, fatigue, stuffy nose, cough, with lots of mucus and cough. Taking Tylenol, OTC cold medication and inhaler as needed. Waiting it out with rest, fluids, medication.
68 2021-01-08 tingling, numbness Daughter called 30 Min after patient left facility (about 1 hr after vaccine) reporting Left side of... Read more
Daughter called 30 Min after patient left facility (about 1 hr after vaccine) reporting Left side of her face was numb and tingling but was easing. MD previously approved vaccination. Patient's daughter was instructed to monitor patient and call MD if symptoms worse.
68 2021-01-09 feeling hot Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), ab... Read more
Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), abdominal cramping, loose stool x 5 over 48 hours. Extreme fatigue (over 5 days)
68 2021-01-11 pain in extremity Sore arm Low grade fever between 101-102 F Really bad body aches Nausea and vomiting that lasted 24 ... Read more
Sore arm Low grade fever between 101-102 F Really bad body aches Nausea and vomiting that lasted 24 hours Fever has continued in the afternoons
68 2021-01-12 tremor Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stom... Read more
Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stomach pain, diarrhea Still experiencing fever and diarrhea.
68 2021-01-12 muscle spasms Lower extremity muscle cramping (not near the site of injection) approximately 18 hours post-vaccina... Read more
Lower extremity muscle cramping (not near the site of injection) approximately 18 hours post-vaccination.
68 2021-01-12 breast pain Pain in the breast/all of a sudden it was just like a shot stinging pain because it's on the same si... Read more
Pain in the breast/all of a sudden it was just like a shot stinging pain because it's on the same side that I had the injection; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142, exp. date: 31Mar2021), via an unspecified route of administration on the arm on unknown date at SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer from 2015 (reported as about 6 years ago and that doesn't have anything) and thyroid disorder (reported as thyroid). Concomitant medication included levothyroxine (LEVOTHYROXINE) for thyroid. On an unknown date, the patient had a side effect of pain in the breast and all of a sudden it was just like a shot stinging pain because it's on the same side of the injection. The patient mentioned that it didn't happen that day of injection, it happened the next night and also then the night after but not as bad. The patient was going to her gynecologist next Tuesday (in 2021) and will check her. Outcome of the event was unknown.
68 2021-01-13 cold extremities 1) Ice cold toes & feet, sweat in toe area of socks 2) confusion, 3) chills
68 2021-01-13 pain in extremity I just had a sore in the left arm the next day; This is a spontaneous report from a contactable Nur... Read more
I just had a sore in the left arm the next day; This is a spontaneous report from a contactable Nurse (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date not reported), intramuscular on the left arm on 28Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included allergies to PCN/Sulfa. Concomitant medications included calcium and an unspecified allergy pill. The patient reported that she just had a sore in the left arm the next day on 29Dec2020 and there were no other problems. No treatment was given for the event. The event was reported as non-serious. The patient had no prior COVID vaccination and did not test positive for COVID post vaccination. The patient recovered from the event on an unspecified date.
68 2021-01-13 pain in extremity Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the fi... Read more
Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the first day after injection and once on the second day after injection. Other S.C. were fatigue, muscle aches, chills, indigestion and sore arm. No fever noted.
68 2021-01-13 pain in extremity Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metal... Read more
Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metallic-type taste and felt tingling around my mouth. I had been sitting in the post-vaccine observation area during this time looking at my telephone. I approached the nurse's desk and reported what I was experiencing and was taken to another room where I was put in a wheelchair and vital signs were taken. By now I think I became very anxious and fearful and my heart felt like it was pounding at 104. My BP went to 188/79 which is high for me and I felt SOB. I truly think the VS symptoms were related to anxiety, but I continued to have the taste in my mouth and my tongue felt like sandpaper. I was given 50 mg BENADRYL and observed for 30 minutes. After that amount of time, I felt better and safe to leave the hospital. Today, 1/14/2021, I have felt excessive tiredness and mentally dazed with diarrhea. No temperature, slight nausea this morning, and no vomiting. My left arm is only moderately sore. Now, at 7:30 pm I am feeling better and feel that I can work tomorrow. Honestly do not know if it was an adverse reaction or excessive anxiety. I do not have anxiety disorder.
68 2021-01-17 migraine Migraine headache on waking days 1, 2 and 3. Joint pain, nausea, lack of appetite, dizziness on day ... Read more
Migraine headache on waking days 1, 2 and 3. Joint pain, nausea, lack of appetite, dizziness on day 2. Same symptoms to a lesser extent Day 3. Day 4 no symptoms.
68 2021-01-18 pain in extremity Approx. 10 hrs after injection I developer soreness at the injection site and upper Left arm. The in... Read more
Approx. 10 hrs after injection I developer soreness at the injection site and upper Left arm. The injection site was tender to touch and a dull ache went down my left arm to the fingers. The symptoms persist into the day after the vaccination.
68 2021-01-18 pain in extremity Approx. 10 hrs. after injection I developed soreness at the injection site and upper arm. Injection ... Read more
Approx. 10 hrs. after injection I developed soreness at the injection site and upper arm. Injection site is tender to touch. I was unable to lay on this arm as I went to sleep. I also developed a dull ache down my left arm to my fingers. These symptoms remain in the day following the injection
68 2021-01-18 weakness Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , h... Read more
Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , headache joint pains , muscle pains , chest pains and nausea as well as Fatigue . I started taking Tylenol 500mg po q 6 hrs and that improve the sxs. The site of the injection was extremely red and swollen as well as lymphadenopathy underneath the left arm ( site of injection). The next day ( sunday) I noticed a swelling underneath the axilla going on top of the bra with blood exudate and looked as if I had bumped an object. The weakness continued during the next week and slowly the tiredness got better ( TOOK AT LEAST 7-10 DAYS).
68 2021-01-19 numbness, tremor 20 minutes after injection , middle finger right hand started jumping for approximately 10 minutes,... Read more
20 minutes after injection , middle finger right hand started jumping for approximately 10 minutes, getting less vigorous with time. 1-10-21 stared having tremors every 2-3 minutes in both hands, left leg and occasionally in right leg. Left leg and bottom of left foot numb feeling off and on.
68 2021-01-19 numbness MINOR NUMBNESS IN RIGHT PALM. RESOLVED WITHIN THE 15 MINUTES
68 2021-01-19 tingling, numbness, pain in extremity Severe L arm pain, L face tingling, numbness, and warm to touch including eye area and eye swelling
68 2021-01-20 pain in extremity, burning sensation 3:18 sitting in general observation and c/o left side arm pain, radiating up neck. Describes pain as... Read more
3:18 sitting in general observation and c/o left side arm pain, radiating up neck. Describes pain as throbbing 5/10. Also c/o nausea. O2 97% on room air, HR 86; EMT on site in attendance. 3:24 BP 206/118 on Lt upper arm taken per EMT 3:30 BP 182/118; HR 118 per radial pulse. States pain now 2/10 is is a dull pain to a burning warm sensation. 3:35 O2 98% r/a, HR 68 3:40 BP 132/80 HR 66, O2 97% r/a. Patient states she is feeling better. Patient decided to go home accompanied by husband to private vehicle. EMT recommended to patient the she f/u with doctor is she feels worse. Ambulated with husband.
68 2021-01-21 pain in extremity Facial swelling within 20 minutes after inoculation. Pain in left arm radiating into wrist and hand ... Read more
Facial swelling within 20 minutes after inoculation. Pain in left arm radiating into wrist and hand - unable to open our close hand. Lasted until next morning.
68 2021-01-22 tremor, weakness 30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudde... Read more
30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudden felt weak, lightheaded, trembly, with chest tightness and a need to lay down. The biggest problem was that my eyes became strangely affected, like there were shutters being opened and closed in rhythmic waves inside my eyes. They were also very photosensitive and blurry. My whole head felt wrong. drove me home, (I could not have driven). This lasted several hours. I had chills and stayed laying down with my eyes closed. By the end of the day I felt mostly recovered. This series of events recurred 6 days later, on Jan. 20th. This time it also lasted most of the day, but I continued feeling moderately unwell the next day, and today it continues. I feel weak and unsteady. My eyes are better but not entirely. They ache and feel insecure. I am not currently feeling up to any activities besides resting.
68 2021-01-23 cold extremities Patient received her vaccination around 730 am on her left deltoid. Patient approached the observer ... Read more
Patient received her vaccination around 730 am on her left deltoid. Patient approached the observer around 735 am about concern of dizziness. Patient also states that she has cancer. Patient was then escorted to the bed stretcher. Patient vital signs were taken in which her BP was 181/91, O2 sat 79%, HR: 104. Patient was also noted to be anxious and states that she does not take any oxygen at home. Patient was encouraged to relax and lay down comfortably on the bed stretcher. Patient was cold upon touch. There was an attempt to warm the patient but the patient was still cold upon touch. Vital signs were taken again in which her BP was 179/84, O2 sat fluctuating between 80-90's. The decision was then made to take the patient to the emergency department.
68 2021-01-23 flushing, feeling hot at 545 PM patient reported feeling warm and flushed vitals at 550 PM 192/88 O2 97 HR 72 given IM B... Read more
at 545 PM patient reported feeling warm and flushed vitals at 550 PM 192/88 O2 97 HR 72 given IM Benadryl 50mg left deltoid at 552 PM repeat VS @ 6 PM manual BP 164/82 and rest of VS WNL monitoring for 10 mins by nurse and paramedic VS @ 610 PM 97%O2 68 HR 150/86 BP on D/C stable and will monitor, to go to ED if SOB, or any signs of distress develop
68 2021-01-24 flushing "Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual was given vaccine at 3:30 pm. 20 minutes after rec... Read more
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual was given vaccine at 3:30 pm. 20 minutes after receiving the vaccine individual developed itchy flushed on face cheeks, chest, and back. She was given Benadryl 50 mg IM in Right arm at 3:55 pm. 4:12 pm the itchy skin was less intensified and vitals were stable. Individual went home with family
68 2021-01-24 numbness, tingling, pain in extremity My reaction did not require medical attention, but I happened to have an appt. with my doctor and me... Read more
My reaction did not require medical attention, but I happened to have an appt. with my doctor and mentioned it to her. She thought I should mention it to you in case it is part of a larger pattern. I had normal reactions of arm pain and headache (not serious) since I had the shot. I have also been experiencing sporadic numbness and tingling in my arm down to my fingers. It does not last long but it comes and goes. It has been three days since the shot and all symptoms have decreased.
68 2021-01-24 weakness, pain in extremity Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aph... Read more
Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards. In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse. With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission. On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
68 2021-01-25 pain in extremity About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hur... Read more
About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hurt to lift my arm. Also had some slight nausea and headache. Took Ibuprofen helped some. Next day still felt off, arm still extremely sore, body aches, headache, fatigue. I continued with the Ibuprofen alternating with Tylenol. Finally felt better by Sunday and was able to return to work on Monday.
68 2021-01-25 flushing, tingling PATIENT BECAME FLUSHED AND HAD ITCHING TO CHIN: AIRWAY PATENT: NO SIGNS OR SYMPTOMS OF RESPIRTATORY ... Read more
PATIENT BECAME FLUSHED AND HAD ITCHING TO CHIN: AIRWAY PATENT: NO SIGNS OR SYMPTOMS OF RESPIRTATORY DISTRESS, SHORTNESS OF BREATH OR CHEST PAIN: HEART RATE 62: 02 99% ON ROOM AIR: RESPIRATIONS 18: LUNGS CLEAR AND NO STRIDOR NOTED: PATIENT PROVIDED WITH WATER: PATIENT STATES SHE "SHE FEELS PRICKLEY ON THE FACE AND HEAD."
68 2021-01-25 weakness Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vac... Read more
Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21 @ 0630, at 2030 developed generalized aching, chills, weakness and sleepiness. Woke up at 0300, went to bathroom and passed out returning to bed. Awakened soaked in perspiration. Had dry heaves and 1 loose stool. Felt weak and sleepy until 0700, then felt mostly normal. Symptoms relieved by 1000. No other symptoms after that".
68 2021-01-26 flushing .On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No ... Read more
.On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No outward sign. Symptoms continued throughout the rest of the day. Mild headache, some nausea. No difficulty breathing, no fever, no hives or rash. General uneasy feeling. Next morning awoke with "fullness "in ears, with some ringing. Facial symptoms would come and go. On Sunday, two days after vaccine, I felt much better, facial symptoms better, ears still felt plugged. Could ear fine. On Monday , symptoms pretty much gone. I was in contact with primary physician through email/phone message. No treatment was necessary.
68 2021-01-26 nerve pain, muscle spasms, weakness 1/18/21 begin muscle cramp starting at lower rib on rt side 1/19/21 next was deep, severe, debilita... Read more
1/18/21 begin muscle cramp starting at lower rib on rt side 1/19/21 next was deep, severe, debilitating pain from mid front center to center back at level of last rib on rt Diagnosed w Shingles, no rash or blisters -severe debilitating nerve pain . Valacyclovir 2 grams a day for seven days 1/27/21 no rash or redness ever developed but nerve pain continues, skin still sensitive to touch, less stabbing sharp debilitating pain to now an aching nagging pain from mid center in a semi circle to mid back.
68 2021-01-26 feeling hot, flushing Hot, red flush on face (particularly cheeks and forehead), slightly puffy, mild tingling in lips I w... Read more
Hot, red flush on face (particularly cheeks and forehead), slightly puffy, mild tingling in lips I was observed for an extra 20-30 minutes. Vital signs were taken. Blood pressure up slightly, heart rate slightly elevated Sent home without treatment but recommended I should take antihistamine at home. I took a 12-hour allegra about 12pm and a single 25 mg benadryl tablet at bedtime. The symptoms lasted about 3-4 hours before resolving. They did not get worse from the immediate reaction. Recommended contacting my family physician for advice of what to do before 2nd shot which is scheduled for Feb. 15, 2021
68 2021-01-27 muscle twitching, tingling, tremor Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injectio... Read more
Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injection; couldn't lift her arm at all; left eye twitching; Chills; Nausea; no appetite; whole body ache; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 11Jan2021 5:15 PM at a single dose on arm for COVID-19 immunization. Medical history included ongoing shellfish allergy from 1975 (she carries epi pen), ongoing iodine allergy from 1975 (she carries epi pen), ongoing Mitral valve prolapse (for 20 years), blood pressure high, and cholesterol. The patient had mitral valve prolapse for about 20 years now. They are just watching it now. She just saw the cardiologist, and had an echo done. If the symptoms worsen, they will proceed. Concomitant medications included diltiazem for blood pressure high and atorvastatin for cholesterol, both from an unspecified date and ongoing; she has been on these medications for 30 years now. On 11Jan2021, the patient experienced facial tingling, immediate pain in arm from injection, couldn't lift her arm at all, left eye twitching, chills, nausea, no appetite, whole body ache, tired, whole body trembled, nervous. On 12Jan2021, the patient experienced back pain. The patient explained that on 11Jan2021, evening at 5:15pm, she received her first COVID 19 vaccine. The Pfizer vaccine was being given out at that time. She has shellfish and iodine allergies. So, they made her sit and wait 30 minutes after being injected. One of her daughters took her. On the drive home, a few minutes after leaving she developed facial tingling. At first, she thought nothing of it. She did have immediate pain in her arm from the injection. By the time she got home, she couldn't lift her arm at all. It was that painful. The next morning, she couldn't lift arm, and if she tried, she would be in pain. Also, her left eye started twitching right away also. That night she really noticed it. It was not a constant twitching. She thought at first it was because she was tired or from the pain in her body. But then she noticed the next day it was still doing that. It was still twitching. It is not constant, but it was here and there. She still had it on 13Jan2021, but so far nothing at the day of report (14Jan2021). She also had chills. She had on double clothes, and coverings on her feet and hands. The chills wouldn't go away. Her whole body trembled. On 13Jan2021, Wednesday morning, they went away. She experienced nausea and no appetite. Her whole body ached. It was so brutal. The problem was with her left eye. It didn't twitch constantly, but it got her nervous. She is pretty sure she is going to refuse the second dose. She has heard that the 2nd part is when most people have the worst side effects. So, she is not comfortable getting it. She also got back pain. It wasn't severe, but it was there. She is against getting the second shot. She stated that she is a medical assistant at a pediatric office. She doesn't have a prescribing doctor. She got it (vaccine) because of her age. She was advised to get it as she was around patients. Work gave them the option. The inability to move her arm ended in the middle of night at 4 am 14Jan 2021. She noticed she could move her arm. Her second dose is scheduled for 01Feb2021 at 8:45 am. She does work in a pediatric office. If the second part of side effects are worse, then she doesn't want to take the chance. The eye has her concerned. Outcome of the events were as follows: facial tingling recovered on 11Jan2021, immediate pain in arm from injection recovered on 13Jan2021, chills recovered on 13Jan2021, nausea recovered on 13Jan2021, no appetite recovered on 13Jan2021, whole body ache recovered on 13Jan2021, couldn't lift her arm at all recovered on 14Jan2021, back pain was recovering, while outcome for events left eye twitching, tired, whole body trembled, and nervous, was unknown. Information about lot/batch number has been requested.
68 2021-01-28 tingling 2 days after vaccine woke up at 1:30 am scalp was burning and face was tingling. Next day same thing... Read more
2 days after vaccine woke up at 1:30 am scalp was burning and face was tingling. Next day same thing and my pressure started going up. After 3-4 days, my hairline started receding slightly on the sides of my scalp in the front. This continued each day and I had to increase my blood pressure medicine and double the dose because it was getting so high. I was anxious and upset and am afraid to take the second dose because I feel that I will get a worse reaction, and am frightened.
68 2021-01-28 pain in extremity On the two hour ride home, my arm would ache then be fine. I was cranky, not myself, going to bed, ... Read more
On the two hour ride home, my arm would ache then be fine. I was cranky, not myself, going to bed, I woke several times as I rolled over onto my right arm. When I awoke early, I was swollen from Head to Toes, my eyes were slits, my bracelets and rings were swollen into my skin, and my toes and ankles were large. AND I was grouchy about everything. As the day went on I was just mad about everything, I began to drink lots of water and tried to exercise to get the swelling down. About noon, my eyes and face began to ease, but my body didn't ease till about 2pm, as my rings and bracelets were movable then. I am still swollen and still angry and it is Friday.
68 2021-01-28 tremor Shakes, tongue and lip sweeping, pain in stomach and headache
68 2021-01-28 pain in extremity shore arm, fever chills body aches nausea and vomiting
68 2021-01-31 pain in extremity PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT L... Read more
PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT LIFT OR USE A SPATULA TO EVEN TURN EGGS OVER IN FRYING PAN. STARTED ON SUNDAY 1/24/21 3 DAYS AFTER RECEIVING FIRST DOSE OF VACCINE. PAIN MINIMAL AT INJECTION SITE, BUT PAIN ALSO OCCURS IN SHOULDER. UNABLE TO RAISE ARM ABOVE HEAD OR EVEN STRAIGHT OUT. WAS SEEN IN URGENT CARE. PROVIDER REPORTS NO SIGNS OF PROBLEMS AT INJECTION SITE. NO REDNESS, NO SWELLING, NO NECROTIC TISSUE.
68 2021-02-03 migraine 2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later devel... Read more
2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later developed headache which increased in intensity and eventually triggered a migraine, severe dizziness making it impossible to sit/stand, muscle aches,nausea. no temperature or chills. The headache lasted all day lasted all day Friday and decreased in intensity by Saturday. With rest, the dizziness resolved by Friday evening. The muscle aches remained mildly for a few days.
68 2021-02-03 weakness Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimm... Read more
Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
68 2021-02-03 pain in extremity Hives arm soreness and a headache
68 2021-02-03 pain in extremity Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate he... Read more
Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate headache, chills, aching (muscles), fatigue, low-grade fever (100.2), mild nausea, sore upper arm Jan. 31: mild headache, mild muscle/joint ache, chills, fatigue, pain at injection site, loss of appetite Feb. 1: mild pain at injection site Feb. 2: all symptoms resolved
68 2021-02-04 pain in extremity, tenderness Patient reported that she received her 2nd COVID vaccine. She reports no symptoms after her first va... Read more
Patient reported that she received her 2nd COVID vaccine. She reports no symptoms after her first vaccine injection. Both injections were in her left deltoid. On the evening of 2/2/2021, she started having some aching in the left arm. She noticed that her left axillary lymph node is swollen and painful. She states the swelling is very significant and it hurts, not just tender to touch. Doesn't look red or feel warm. No fever. She took ibuprofen 400 mg. Patient advised to follow-up with her PCP.
68 2021-02-04 weakness The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ... Read more
The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
68 2021-02-05 feeling cold Early morning after vaccine started with headache then nausea and chilling. Chilling all day and ev... Read more
Early morning after vaccine started with headache then nausea and chilling. Chilling all day and evening Fever must have broke about 24 hours or so after with breaking out in a sweat. Symptoms just keep getting worse as the day progressed . Almost 24 hours after the bones just hurt. Today, 2/6/21, two days after vaccination still have nagging headache
68 2021-02-05 pain in extremity Headache beginning 5 hours after time of vaccination continuing until 16 hours after vaccination Arm... Read more
Headache beginning 5 hours after time of vaccination continuing until 16 hours after vaccination Arm soreness from 5 hours after vaccination until 36 hours after time of vaccination
68 2021-02-05 weakness Low grade temp. 100.2 All over body aches tired/no energy I took 1250mg. Tylenol, 2x's on 2/5/2021 a... Read more
Low grade temp. 100.2 All over body aches tired/no energy I took 1250mg. Tylenol, 2x's on 2/5/2021 and slept most of the day. Today, 2/6/2021 I feel fine. No further symptoms and no further need for Tylenol.
68 2021-02-07 migraine Approx 5-10 min after receiving the injection patient c/o not feeling well, lightheaded, visual migr... Read more
Approx 5-10 min after receiving the injection patient c/o not feeling well, lightheaded, visual migraine (has history of. Assisted to private location and removed some of her winter garments to cool her. She also took in water as she had not drank much that day she stated. Ice pack to the back of neck also applied. Vitals taken and wnl. Affter approx 10 min patient states headache resolved and was feeling slightly better. Observed till symptoms resolved. Denies any resp symptoms during entire process. No swelling anywhere on person.
68 2021-02-07 cold sweat, weakness, numbness Felt week and clammy, reported trouble swallowing then numbness in face; rapid response called, tran... Read more
Felt week and clammy, reported trouble swallowing then numbness in face; rapid response called, transferred to ED. 1:43: HR: 74, RR: 16, O2: 97%, BP: 112/66 END Other daily meds: Protonix, Simbicort, Eliquis(Unable to type on 2nd page)
68 2021-02-07 weakness Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ... Read more
Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ashy/pale complexion. Felt extremely weak in the evening.
68 2021-02-07 unresponsive to stimuli Patient was found unresponsive on 2/5/2021. Brought immediately to Emergency department due to respi... Read more
Patient was found unresponsive on 2/5/2021. Brought immediately to Emergency department due to respiratory depression/distress. At this time it is unclear etiology of presentation. However patient is slowly becoming more alert/awake.
68 2021-02-07 weakness Pfizer-BioNTech Covid 19 Vaccine EUA Rash Elevated blood pressure Elevated heart beat ... Read more
Pfizer-BioNTech Covid 19 Vaccine EUA Rash Elevated blood pressure Elevated heart beat Dizziness and weakness Observed on site by EMS and nurses for approximately 1 hour
68 2021-02-07 numbness her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in pa... Read more
her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in parts of the ear and is now able to feel parts of the ear, but she is not sure if the numbness will go away; Caller mentioned that she can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 68-year-old female patient received her 1st bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/lot number: EK9231) single dose on 22Jan2021 10:45 AM at right arm for COVID-19 immunization. Medical history included COVID on 05Nov2020 but was mild only and she was not hospitalized; No medications aside from over-the-counter drugs. The patient was given a Z-pack and vitamin C and immune stuff like Zinc. Concomitant drugs included high blood pressure medication. Around 6:00 PM on 22Jan2021, the patient can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear - the same side of her arm she received the vaccine. The patient stated it was better on 25Jan2021 but still not 100 percent. The patient tried calling the emergency room and has read up and no one can give her any answers. She made an appointment this morning with her doctor to see what was going on, states not being able to hear messes with her equilibrium. The patient was supposed to have another dose on 12Feb2021 and wanted to know if she should. The patient currently still had partial hearing loss and was prescribed a Prednisone that she took for 5 days. Her arm did not hurt Friday through Sunday, however, on Monday, her arm was red, swollen, and growing. She was able to get partial hearing back after taking Prednisone. She had numbness in parts of the ear and was now able to feel parts of the ear, but she was not sure if the numbness will go away. The outcome of hearing loss was resolving, of other events was unknown.
68 2021-02-07 pain in extremity pain down left arm to wrist and hand (still there); pain down left arm to wrist and hand (still ther... Read more
pain down left arm to wrist and hand (still there); pain down left arm to wrist and hand (still there); unable to open & close left hand until next morning; Headache; occasional chills; fever; fatigue; Mild facial swelling; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263; expiry date: unknown) via an unspecified route of administration in the left arm, on 21Jan2021 at 14:00, at a single dose, for COVID-19 immunization. Medical history included allergies to Sulfa. The patient did not have other chronic health conditions. Concomitant medications included turmeric [curcuma longa rhizome], and ashwagandha. The patient previously took doxycycline and experienced allergies. On 21Jan2021, the patient had mild facial swelling 20 minutes after inoculation, at 14:30 the patient had pain down left arm to wrist and hand (still there), unable to open and close left hand until next morning, headache, occasional chills, fever and fatigue. The patient did not receive treatment for the events. The events were considered non-serious. The patient was recovering from the events.
68 2021-02-08 difficulty speaking Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain... Read more
Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain and headache. Early evening I developed hoarseness and trouble breathing. Went to Emergency room. They administered IVwith Benedryl; Prednisone; and Pepcid. After an hour my breathing was better and some of the redness on arm was better. I went to physician on 2/5/2021 because of neck pain and was prescribed MethylPrednisolone Tablets, 4 MG. 6 day pack and was on day 3 when the symptoms started.
68 2021-02-08 pain in extremity, weakness suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support her... Read more
suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support herself to walk around in her home; pain in her upper and lower extremities/ this bilateral upper and lower extremity pain; stiffness and weakness beginning at the shoulders and hips; dull headache; This is a spontaneous report from a contactable healthcare professional. A 68-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 14Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), COPD (chronic obstructive pulmonary disease), previous TIA (Transient ischemic attack) with some residual right sided weakness, CHF (congestive heart failure), osteoarthritis. Had a childhood vaccination history. No Known allergies. Concomitant medications included albuterol, aspirin, atorvastatin, fluticasone, furosemide, hydralazine, ibuprofen, lisinopril, metoprolol, multivitamin, all above were in two weeks (as of 25Jan2021). The patient previously received influenza vaccine yearly, and received her pneumonia vaccines over the last several years, both for immunization and never had a reaction to a vaccine. The patient was not pregnant at time of vaccination. No other vaccine received in four weeks. The patient developed a dull headache on 15Jan2021, one date after the vaccine, but that it resolved after 24 hours on 16Jan2021. On 16Jan2021 at 8:00 AM, the patient developed bilateral proximal muscle stiffness, weakness, and pain in her upper and lower extremities over the course of 1 week. The patient started experiencing this bilateral upper and lower extremity pain, stiffness and weakness beginning at the shoulders and hips and extending distally over several days. Her symptoms started out relatively mild and progressively got worse over the course of 7 days. She presented to the reporting healthcare professional 8 days after her vaccination and she was extremely weak and could not support herself to walk around in her home, the reporting healthcare professional suspect polymyalgia rheumatica. All the events (except dull headache) resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalization due to all the above events for 3 days. The patient had a remarkable response to the treatment of prednisone during her hospitalization. It was unknown if covid prior vaccination. The patient underwent lab tests and procedures, which included COVID tested (COVID test type: Nasal Swab, SARS-COVID19 PCR) post vaccination on 23Jan2021: Negative. Outcome of event headache was recovered on 16Jan2021 and all the events was recovered on an unspecified date. Information about lot/batch number was requested; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded, considering the temporal relationship. However, it is worth noting that the 68-year-old female patient had pre-existing osteoarthritis, which could be one of the causes of joint symptoms. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-02-09 weakness, pain in extremity Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 P... Read more
Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 PMon the 6 Feb. 2021. body aches. On 7th the same. Nausea went away on 8th. arm sore. went away on 9th. the nasty taste still have it on 10th. No headche stopped on 9th. Just feel week. going away on 9th of Feb.
68 2021-02-09 numbness, tingling Pin prickly feeling in different areas of her body; Headache; Funny feeling on the top of her head a... Read more
Pin prickly feeling in different areas of her body; Headache; Funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation; Stinging feeling in sinus cavity; This is a spontaneous report from contactable consumer (patient) A 68-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot#292673 on left deltoid (reported as left shoulder) on 25Jan2021 11:21 at SINGLE DOSE for covid-19 immunisation . Medical history included diabetes from 11Sep2001 and ongoing , ongoing cardiac pacemaker insertion Put in about 7 years ago , ongoing blood cholesterol increased Diagnosed about 24 years ago , ongoing blood triglycerides increased. She is allergic to statins. Concomitant medication included alirocumab (PRALUENT) 1 mL at 1ml injection every 14 days for High cholesterol (Injection on side or top of her leg. She has been taking for about 4 year).The patient experienced headache on 25Jan2021 with outcome of recovered , funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation on 25Jan2021 with outcome of unknown , stinging feeling in sinus cavity on 25Jan2021 with outcome of recovered , pin prickly feeling in different areas of her body on an unspecified date with outcome of unknown. Clincial course reported as follows:She got the first dose of the vaccine today and while she was sitting in the observation area, she started getting a headache. It was close to noon and she just blew the headache off since she was a diabetic. She started getting a funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation. When the feeling hit her sinus cavity, it was like a stinging. She started drinking water and she had lunch. Within an hour it started getting better and within 3 hours it was a lot better. She has a pin prickly feeling in different areas of her body but did not have the numbness sensation. She tried to report this online. She only had one virtual visit with her doctor. Treatment: declines any, she was drinking plenty of water to try and flush some it out of her system.
68 2021-02-09 tingling, muscle spasms, pain in extremity, discomfort, burning sensation, feeling hot The heat from the elbow (not clarified further), besides the knees and the ankle and the toes.; pain... Read more
The heat from the elbow (not clarified further), besides the knees and the ankle and the toes.; pain in knees, ankles and feet and lower leg with the cramping and tingling, mostly tingling and burning like a radiating pain; discomfort with burning , tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine; discomfort with burning , tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine; I experienced discomfort with burning , tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine; Also occasionally pain in hips, elbows and other joints/Pricking pain in my left hip/mild burning radiating from around the joints; cramping in my left footmy knees, my ankles and my feet, the lower leg felt cramp; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose bnt162b2 (BNT162B2, lot number: EL1283), via an unspecified route of administration, at arm left, on 12Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included blood cholesterol increased, chronic productive cough, known allergies to sulfa, sinus disorder. Is pregnant: No. Concomitant medication included mometasone furoate (FLONASE) for sinus, ascorbic acid (VITAMIN C). No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. 4 days after receiving vaccine, on 16Jan2021 12:00 AM the patient experienced discomfort with burning, tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine and have continued for more than 30 hours now , Also occasionally pain in hips, elbows and other joints. As of 23Jan2021, it was reported the patient experienced burning, tingling sensations around ankles, knees and lower leg. Yesterday started feeling same thing, the feet, toes, around ankles, up legs and around knees. Sometime it feels like it's a mild burning radiating from around the joints and in the lower leg too. It is mainly her feet up to above the knees, burning, tingling, radiating. Sometimes have occasional pain little bit in some of the other joints, this is a little bit more than joint pain. Consumer stated, that she received the first dose of this Pfizer Vaccine on 12Jan2021. And about four days after during the night she was feeling some kind of burning, tingling sensations around ankles and knees and lower leg. It went away it lasted maybe about 4 hours, but then yesterday which is on the 22nd started in early afternoon started feeling the same thing, the feet and the toes, around ankles, up the legs and around the knees. Sometime it feels like it's a mild burning radiating from you know around the joints and in the lower leg too. It is mainly feet up to above the knees, burning, tingling, radiating. And sometimes I have occasional pain in just a little bit in some of the other joints you know that's been going on after the vaccine occasionally. The heat from the elbow (not clarified further), besides the knees and the ankle and the toes. The patient called this number because that is the number that was on the page to say if there was anything to report and then you know she was wondering if this is, she saw that some of the side effects could be joint pain but this is a little bit more than joint pain. So, she was wondering if there is anything. She mean she was going to see doctor on Monday, this has been going on for more than 30 hours now, but she was wondering if there is any advice in this. Pricking pain in her left hip started on 12Jan2021, Little bit of cramping in left foot started on 12Jan2021, Knees, ankles and feet, the lower leg felt cramp, like a radiating pain started on 16Jan2021. Consumer stated, initially, when she just got the vaccine, she felt a little prick in her left hip, like a little pain but it did not stay, pricking pain in her left hip. A little bit of cramping in her left foot, but it went away. So she did not think anything of it. 4 days later, on the 16Jan2021 (later confirmed), during the night her knees, her ankles and feet, the lower leg felt cramp, like a radiating pain. It was not very severe, like a mild pain in the knees and the lower legs and feet, a type of tingling but it went away. Pain was like a radiating, sort of burning but it was mild burn. Date when started experiencing pain is on the same day, 12Jan2021. Lab work was no. Treatment was no, because it was transient but afterwards what concerned her is on Friday which is the 22nd, she started experiencing a pain in knees, ankles and feet and lower leg with the cramping and tingling, mostly tingling and burning like a radiating pain. The whole, above her knees, down the lower leg, ankles, feet and toes and it continued up till last night and so more than for 30 hours that is what concerned her. That is why she called last night. The outcome of the event feeling hot , pain in extremity, muscle spasm was unknown, of the other events was not recovered.
68 2021-02-10 pain in extremity, weakness arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; f... Read more
arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; fatigue; Muscle aches and pains; she became ill; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 06Jan2021 at single dose on right deltoid for covid-19 immunisation. Medical history included blood pressure high and seasonal allergies. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 16Dec2020 for COVID-19 immunization. The patient experienced community acquired pneumonia, shortness of breath, chest congestion, weakness, fatigue, COPD, muscle aches and pains, she became ill, all on12Jan2021; arm soreness on an unspecified date. Events required Emergency Room visit. Clinical course reported as: she got the second dose of the pfizer covid vaccine on 06Jan2021 and on 12Jan2021 she experienced shortness of breath, chest congestion, weakness and fatigue. Nurse stated ER doctor thought she had COPD or community acquired pneumonia. Nurse further stated she had the second COVID-19 vaccine on 06Jan2021. A week later on 12Jan2021, she became ill. She had all the symptoms of COVID. She was short of breath, very fatigued. She couldn't get any air, she was at work. She had muscle aches and pains. The shortness of breath, fatigue and weakness lasted several days. She also had severe chest congestion. She confirmed she got better. It actually took 4 or 5 days. By that Sunday (17Jan2021) she was better. She wanted it noted she had no reaction right after the shot. She stated she only had arm soreness, it was just a little sore, not even worth mentioning. It was only when she moved her arm a certain way. This was with either vaccine (first or second vaccine). She went to the doctor and somebody thought it might be a reaction, but the nurse thought it was too late for a reaction. The ER doctor thought it was COPD and community acquired pneumonia. Her primary doctor thought it was COPD. The patient underwent lab tests and procedures which included COVID-19 test: negative on 12Jan2021. Outcome of arm soreness was unknown, others was recovering.; Sender's Comments: Based on the drug-event time interval and the vaccine's safety profile, the community acquired pneumonia is possibly intercurrent condition, unrelated to vaccine BNT162B2 administration, which is not the disease that the vaccine BNT162B2 can prevent from. While the COPD is more likely underlying condition, unrelated to vaccine BNT162 injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-02-14 facial paralysis right side of face drooping, diagnosis Bells Palsy; This is a spontaneous report from a contactable ... Read more
right side of face drooping, diagnosis Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: El8982), via an unspecified route of administration on 29Jan2021 09:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot: El3246) received on 08Jan2021 at 03:00 pm on left arm for COVID-19 immunization. The patient experienced right side of face drooping, diagnosis as bell's palsy on 31Jan2021 06:00 with outcome of not recovered. Treatment received for the event included prescriptions. This event resulted in emergency room/department or urgent care. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination.
68 2021-02-15 pain in extremity 68-year-old female evaluated for painful movement of her extremities. Patient reports that her sympt... Read more
68-year-old female evaluated for painful movement of her extremities. Patient reports that her symptoms started the day after receiving the Pfizer COVID-19 vaccine at pharmacy. Patient was admitted. Patient has been evaluated by Neurology, Rheumatology and the Ortho-Spine Service. Symptoms improved with prednisone. Although unclear, a diagnosis of polymyalgia rheumatica was being considered due to elevated CRP (inflammatory marker). Relationship to vaccine administration is also unclear. Pt with Hx of arthritis, COPD, CAD, CHF, and HTN received first dose of Pfizer COVID-19 Vaccine. Within 24 hours of vaccine administration, pt went to hospital c/o of painful movement of extremities. Pt was treated with prednisone and symptoms improved. She was evaluated by multiple specialties including neurology, rheumatology and orthopedics without a clear diagnosis. Her CRP was elevated to 17.2 mg/dL and Sed Rate to greater than 130 mm/hr and reactive ANA titer. Total CK was normal at 23 IU/L. Rheumatology wrote this is highly suggestive of COVID-19 vaccine induced polymyalgia rheumatica which has been reported with other vaccines but not with COVID-19 vaccines.
68 2021-02-15 numbness tip of nose was numb, top lip, chin, forehead cheeks were also numb, eyes felt different
68 2021-02-16 nerve pain lower back pain; nerve pain; excruciating pain/getting pain; muscle pain; couldn't sleep with the pa... Read more
lower back pain; nerve pain; excruciating pain/getting pain; muscle pain; couldn't sleep with the pain; Her husband had to pull her out of the bed because she felt she had no muscle activity; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EL8982), via an unspecified route of administration in the left arm on 17Jan2021 at 15:00 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included benign spinal cord tumor from 1987 and unspecified if ongoing (a lot of bone had to get cut), lot of scar tissue (wonders if it is a weak spot) from an unspecified date and unspecified if ongoing, thyroid removed in 2015, neurosurgery (to remove the benign spinal cord tumor) on an unspecified date, thyroid on an unspecified date and unspecified if ongoing and cholesterol from an unspecified date and unspecified if ongoing. Concomitant medications included ongoing levothyroxine (strength: 125 ug) taken for an unspecified indication at 125 ug, 1x/day, ongoing pravastatin (strength: 40mg) taken for cholesterol from an unspecified date at 40mg, 1x/day and ongoing multivitamin. The patient did not receive any other vaccinations within four weeks prior to the first administration of the COVID-19 vaccine. The patient experienced lower back pain, nerve pain, excruciating pain/getting pain, muscle pain, couldn't sleep with the pain and her husband had to pull her out of the bed because she felt she had no muscle activity, all on 17Jan2021. The patient called and stated "she had a very extreme reaction from the first dose of the vaccine, which she had last Sunday the 17th. It began with lower back pain, which did not alarm her too much but then it went in to nerve pain. By the end of the evening, by about midnight, she was in what she considered to be excruciating pain. She changed positions and it was hitting the nerve and she was getting pain and having muscle pain. She was up all night because she could not sleep with the pain. Monday and Tuesday were very excruciating, and she took Tramadol Monday after consulting with her doctor. She did not get any relief until Wednesday, 3 days after the shot. Even today she had some lower back pain, but it is way better than it was. It was improving from Wednesday to today but Sunday to Wednesday was excruciating since it was giving her nerve pain. Her husband had to pull her out of the bed because she felt she had no muscle activity. In 1987 she had a spinal cord tumor and a lot of bone had to get cut and she stated she was sure she had a lot of scar tissue and wondered if it was a weak spot. She stated this could be an isolated incident, but she really thought she had another tumor at first until it started dissipating on its own. She stated she did not know anyone who has had this reaction and asked if it was safe/advisable to get the second shot? She stated she was afraid of the permanent nerve damage but as long as it cannot do anything permanent, she wanted to get it. Was this a reported symptom? Has anyone ever gotten paralyzed? After verbal response she stated she will talk with her doctor and maybe see a neurologist." Upon follow-up the patient called and stated "I had two questions actually. I received the Pfizer Vaccine yesterday and last night I started with the excruciating back pain, my lower back. I do not know if it was coincidence or not because I have back trouble before. I did not do anything to throw my back out. However, I was told it would be okay to take Extra Strength Tylenol. I took 4 Tylenol within like 3 hours period because it was not working. I took another two this morning. Tylenol was not doing anything at all for the pain relief. My question was, I have a prescription of Tramadol which I took for pain for different reason, but I have it. First of all, I hope by taking the Tylenol yesterday that it did not interfere with the efficiency of the vaccine. My other question is can I take the Tramadol now? Since the vaccine was 24 hours ago would it interfere with efficiency?" Upon follow-up the patient called to report that "she went to her chiropractor late Wednesday afternoon, and he did some stretching, but her spine was not out of alignment, so he felt her pain was due to the vaccine. Stated that it was not until her back started getting better on Wednesday without treatment that she first started to attribute it to the vaccine, because her back just did not get better on its own. Stated that the first day she did not take anything for the pain because she was worried that it might interact with the vaccine or its effectiveness, but the next day she began taking Tramadol pain meds that she already had in the house for her knee. Stated that the pain in her back was so bad, that even a strong medication like the Tramadol did not take away the pain. It did not help all that much, she had to take a 2nd 50mg tablet 3 hours later. Should she get the second dose of the vaccine? Could it possibly do more nerve damage; could she be jeopardizing her nervous system? Have there been any other reports about this? Stated that other people had minor things like, one person reported being tired for a couple days, and another person reported body aches like with the flu, but after 3 days they both were fine. Her husband was 74 and had the vaccine and he had no side effects." The events prompted a visit to her physician. The patient stated that "this was the first day since Sunday that she was feeling almost 100%. She had the pain from Sunday evening all the way until noon on Wednesday; at that point it improved about 50% and she had some mobility." The outcomes of the events lower back pain, nerve pain, excruciating pain/getting pain, muscle pain, couldn't sleep with the pain and her husband had to pull her out of the bed because she felt she had no muscle activity were all recovering/resolving.
68 2021-02-16 numbness out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck ... Read more
out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck was numb/Numbness in leg/jaws are numb; I'm feeling my teeth are still and my jaws are numb; felt very odd sensation as she was swallowing; was closing up but much wasn't closing up/it was not full open; swelling on her throat; Muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side; it hurts my neck area across my back; it hurts my neck area across my back; Stumbling; face was swollen; eyes looks like little switch; thirsty; felt very sluggish; nose started to running; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 29Jan2021 15:00 for COVID-19 immunization. Medical history included insomnia and asthma. The patient's concomitant medications were not reported. Patient stated, "I got the vaccine yesterday about 3 pm and I came home and I had dinner and sat down to watch TV at 9 O' clock, I turn the program on and I was out like a 'light' and this stuff knock me out (onset date: 29Jan2021). My dog has to wake me up licking my face at 3:15 this morning. I normally don't sleep long 4 hours and that's it. I'm 68 years old and I have insomnia (History) but when I woke up I was stumbling around, still have to sleep (onset date Jan2021), I took the dog out to walk and came back and saw myself in mirror, my face was swollen and my eyes looks like little switch. I noticed, I was thirsty and I went to get and drank, some coke because I felt very sluggish and I drank some coke and when I was swallowing the coke I felt very odd sensation as I was swallowing, I noticed that after swallowing. I have asthma (History) to begin with so I'm anticipated on having some of the symptoms it start showing up a bit, my nose started to running and I noticed that my whole entire face my head, down my back my neck was numb along with swelling on my throat, I felt okay but I felt it wasn't being, it was closing up but much wasn't closing up you know what I mean it was not full open. I also had muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side. I also noticed I went to a lovely person and when I went to bathroom I pull my pants down I felt numbness on my legs. So, my whole body was kind of having that not tingling sensation but numb and when I ran my fingers across my leg you know how you feel numbness when you run your fingers across a part of your body when it's numb that's exactly how I felt and that was about 3:30 this morning that happened I woke up by but I also want to ask question because I got to go back to my second shot. I'm wondering if I go back to my second dose am I going to have even more intense reaction to the stuff that I get this time." Patient further added "I was still trying to eat something but I'm feeling my teeth are still and my jaws are numb and this I got since yesterday (29Jan2021)." The outcome of events was unknown. Information on the lot/batch number has been requested.
68 2021-02-17 feeling hot fluttering heart; Started light headed; sharp chest pain; hard to take a breath; Face turned hot and... Read more
fluttering heart; Started light headed; sharp chest pain; hard to take a breath; Face turned hot and bright red/Felt like my head was on fire; Body ache all night; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265, expiry date: unknown), via an unspecified route of administration on 02Feb2021 at single dose (Right arm) for COVID-19 immunization. Medical history included Mild Asthma and Known allergies: Penicillin, Sulfa, Levoquin. Patient is not pregnant. Concomitant medication included prednisone (short course). The patient previously took bnt162b2 for COVID-19 immunization {product=COVID 19, brand=Pfizer,lot number=EJ1686, lot unknown=False, administration date=12Jan2021, vaccine location=Right arm, dose number=1}. It was reported that the patient started light headed, then sharp chest pain, fluttering heart, hard to take a breath. Face turned hot and bright red. Felt like my head was on fire. Body ache all night. Started happening about 3 hours after vaccine dose. Events started on 02Feb2021 13:00. Did not go to ER, no treatment. Stayed home and rested. The outcome of the events was recovering.
68 2021-02-19 pain in extremity 2 days after the vaccine, I started having severe pain in my knees down my legs. I'm on day 17 and i... Read more
2 days after the vaccine, I started having severe pain in my knees down my legs. I'm on day 17 and it is at times unbearable. My knees don't want to bend. I can't take an anti-inflammatory because I'm on a blood thinner. So far just taking Tramadol and Tylenol Arthritis. Doesn't touch the pain. Still working with doctor to figure out what to do next.
68 2021-02-21 numbness, facial paralysis Bell's Palsy; Left sided droop of her mouth; Slight change in sensation all over her mouth; Unable t... Read more
Bell's Palsy; Left sided droop of her mouth; Slight change in sensation all over her mouth; Unable to tightly close left eye, or able to raise left eyebrow; Slight numbness left side of face; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EM9810) in the left arm, at single dose, on 04Feb2021 at 14:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included high cholesterol and lichen planopilaris of the scalp, both from an unspecified date. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included ergocalciferol (VIT D); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); doxycycline; rosuvastatin and minoxidil. On 04Feb2021, at 17:00, the patient experienced a slight change in sensation all over her mouth with left sided droop of her mouth, unable to tightly close left eye, or able to raise left eyebrow. Also slight numbness left side of face. Emergency room/department or urgent care required. The patient went to Urgency Care diagnosed with Bel's Palsy. Treatment was received: prednisone and valacyclovir. The patient did not recover from the events a time of this report. Post the vaccination, the patient has not been tested for COVID-19.
68 2021-02-21 pain in extremity, numbness Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat clo... Read more
Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.
68 2021-02-21 burning sensation Started getting some burning around the left eye & nose.Same area I had shingles 10 years ago. By M... Read more
Started getting some burning around the left eye & nose.Same area I had shingles 10 years ago. By Monday left eye swollen shut. Saw opthmologist prescribed Acyclovir. Over a couple days swelling dissapeared and burning, itching subsided. The thing is, I had my second COVID dose on 02/10/2021, 10:00AM Pitzer Lot #9581. On 02/18/2021 late evening, started to feel burning in left eye nose area again, next morning eye swollen shut. Saw Dr, said I was having an allergic reaction and put me on prednesone and Amoxicylin. No reduction of swelling and burning, blisters were forming. Went to Urgent Care on 2/20/2021 and was prescribed Acyclovir again. Swelling now gone and itching burning diminished.
68 2021-02-22 weakness Dizziness, weakness, sweating, confusion,stumbling when trying to walk.
68 2021-02-23 weakness Diarrhea for two days and some weakness from the diarrhea
68 2021-02-23 numbness Sudden Onset of Chest tightness and numbness in left arm. History of AFIB and Diabetes. PT Denies ... Read more
Sudden Onset of Chest tightness and numbness in left arm. History of AFIB and Diabetes. PT Denies SOB, Nausea, or Vomiting. Pt given 324 mg ASA prior to medic arrival. M48/L48 responded and evaluated patient including cardiac monitoring. Pt refused treatment or tx.
68 2021-02-23 weakness Swelling in throat, tongue, face and then eyes. fast heart rate. rash on face and dizziness and we... Read more
Swelling in throat, tongue, face and then eyes. fast heart rate. rash on face and dizziness and weakness Give prednisone and benydrl in IV and took 1 50mg prednisone at home. Weakness for 3 days and swelling has gone down
68 2021-02-24 burning sensation *On Saturday, February 20, 2021, I began feeling a slight burning sensation under my left side, unde... Read more
*On Saturday, February 20, 2021, I began feeling a slight burning sensation under my left side, under my armpit area. I also noticed small, red blotches. *By Sunday, February 21, 2021, there were more blotches that had spread across to my back and across my chest on the left side. There was severe burning, zinging pain that traveled across my chest, under my left arm, and across to my back. * Monday, February 22, 2021, I visited the Doctor who confirmed it was shingles. She prescribed 1 gram of Valacyclovir (Valtrex) 3x daily for 7 days. *The shingles have now covered my entire left breast, under my entire left arm area with a huge patch on my back. It has become extremely uncomfortable with much burning, stinging, and zinging that travels along the rash area and down my left arm.
68 2021-02-24 flushing Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10... Read more
Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10 minutes into observation she developed abdominal pain and felt like she needed to have a BM. She sat on the toilet and had an episode of diarrhea and started to feel flushed, diaphoretic and stood up to go to the sink. She then felt nausea, dizziness and lightheaded and placed her head down leaning over the sink. EMT arrived to bathroom and sat patient down in a wheelchair. I arrived on scene shortly thereafter and the patient was pale and diaphoretic stating she did not feel well. EMS was activated. She was placed on the cardiac monitor and her HR was NSR in the 80's. BP 114/61, 96% on RA. Denied CP, SOB, rash, mouth, lip or tongue swelling. She was brought back to the observation area and was assisted to the gurney. Cool compresses were placed on her forehead and behind her neck. Medics arrived to scene to assess the patient. She stated she was feeling improved and did not want to go to the ED. She signed the AMA form. She was given water and crackers. She was monitored for 1 hour and stated she felt improved. She denied dizziness, lightheadedness, nausea or abdominal pain. I assisted her to the bathroom and she had one more episode of diarrhea. She stated she felt improved after that. She was monitored for 15 more minutes and stated she would like to go home. She was able to get up off the gurney without assistance, stated she felt well. She was ambulatory with a Steady gait and assisted outside. Prior to discharge I recommended she follow up with her PCP. Advised that she rest for the remainder of the day and to activate 911 should she develop any new or worsening symptoms. Advised that if she does get the second dose of vaccine she should be laying down at the time of administration and for 30 minutes after the injection for observation.
68 2021-02-24 numbness Redness @ injection site moving down arm to wrist, intense itching of arm with mild numbness, follow... Read more
Redness @ injection site moving down arm to wrist, intense itching of arm with mild numbness, followed by mild itching, swelling and redness of lips and perimeter of eyes, spike in blood pressure and dizziness, alleviated with paramedic?s IM inflection of 50 mg benedryl and a steroid pill at ER
68 2021-02-25 feeling hot 15 mins after injection, head, face, neck and chest turned bright RED. Felt hot. Alerted staff . I... Read more
15 mins after injection, head, face, neck and chest turned bright RED. Felt hot. Alerted staff . I took 25mg ODT Benadryl. Observed by staff for 15 mins more. Skin returned to normal color. NO Swelling, No Breathing problems. Went home , no additional problems.(Slightly sore at injection site, expected).
68 2021-02-25 pain in extremity Sore arm, low grade fever, chills, headache
68 2021-02-25 pain in extremity Tues 2/23/2021: fever no greater than 101, chills, fatigue, body ache, headache all day, very sore a... Read more
Tues 2/23/2021: fever no greater than 101, chills, fatigue, body ache, headache all day, very sore arm. Fever treated with tylenol Wed 2/24/2021: No fever in morning, but headache, body ache, mild fatigue all day, sore arm, then fever of 102 in evening (about 5 pm). Treated with Tylenol successfully, fever abated pretty quickly. Thursday 2/25/2021: No fever or headache, but arm still pretty sore without tylenol. Friday 2/26/2021: feeling fine, arm is very slightly sore.
68 2021-02-25 weakness high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, w... Read more
high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, weakness, overall feeling not well.
68 2021-02-25 facial pain lumps in back of neck, they hurt; lumps in back of neck, they hurt; pain goes around into jaw, up in... Read more
lumps in back of neck, they hurt; lumps in back of neck, they hurt; pain goes around into jaw, up into the face; pain goes around into jaw, up into the face; ear hurts; felt dizzy; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 23Jan2021 at a single dose for covid-19 immunization. Medical history included high blood pressure (Diagnosed 3 to 4 years ago) and thyroid disorder. There were no concomitant medications. It was reported that the patient got the vaccine on Saturday and went home and fell asleep, woke up and had lumps in back of neck, they hurt, pain goes around into jaw, up into the face and ear hurts. The patient just tried a hot compress, a hot cloth on there, it seemed to help a little bit for a while. Took some Advil and that helped a little bit, but when it wears off it comes back. Adds she felt dizzy too, and still felt like that too, it started right after she got it, and it comes and goes. The outcome of the event dizzy was unknown while not recovered for the remaining events. Information about lot/batch number has been requested.
68 2021-02-26 feeling hot 11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:... Read more
11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:30 eggy taste, slight shot ache, 4:30 light headache, 02/13/2021 2:30am woke with a rush feeling of med, started coughing, burst (spread) of warmth in center of chest, slight perspiration; 3:30am heart racing, warmth in chest, modest itchiness(arm, face & torso), soreness at injection site. 02/14/2021 7am burning/ itching injection site, & chest/torso arm red and square blotch about 1 1/2 inch very itchy and burning for several days. 02/23/2021 itchinesss better. Brown square area at site of injection. There is still a slight itch at times as if healing.
68 2021-02-26 flushing FLUSHING AND DIZZINESS THAT IMPROVED WITH A FAN. FLUSHING WAS FIRST BUT NOT AS SEVER.
68 2021-02-26 pain in extremity KNUCKLES SWELLED UP WITHIN 48 HOURS, WHEN DRIVING IT WAS UNCOMFORTABLE TO HANDLE THE STEERING WHEEL.... Read more
KNUCKLES SWELLED UP WITHIN 48 HOURS, WHEN DRIVING IT WAS UNCOMFORTABLE TO HANDLE THE STEERING WHEEL. USED OTC PHARMACY BRAND MENTHOL BASED ROLL ON TO DEADEN THE PAIN. NOT EVER HAVING ARTHRITIS, I BELIEVE THIS DISCOMFORT WOULD BE SIMILAR AS MY KNUCKLES WERE THROBBING. PLEASE NOTE, THAT THIS SWELLING IS NOW SUBSIDING, DID NOT AFFECT ANY OTHER JOINTS.
68 2021-02-26 inability to speak Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itch... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itching. Shortly after, developed a dry cough and reported that her throat "felt funny." Patient began vomiting and having difficulty breathing, speaking in 1-2 word sentences. Pt received epi pen to left thigh, with some resolution of symptoms. Pt continued to have cough and nausea, chest pain. Gave 25 mg benadryl IM at 08:27 am. Patient received 2nd dose of Epi for increased SOB, difficulty breathing, and increasing cough, with some resolution of symptoms. Patient reported increased chest pressure. Began having seizure like activity at 08:30, lasting approx 20 seconds with no post ictal period noted. EMS arrived after 2nd dose of epi. Second "seizure like" activity after EMS arrival, lasting approx 20 seconds. During transport to ambulance, patient had 2 more episodes of seizure like activity with no post ictal phase. ED note states low suspicion for true seizure since patient was awake during episodes of tonic clonic movements, answering questions during, and did not have post ictal state.
68 2021-02-26 pain in extremity Very distinct large red blotches about 5 inches long by 1 inch wide above the injection site. Also, ... Read more
Very distinct large red blotches about 5 inches long by 1 inch wide above the injection site. Also, a large rash with white bumps on chest area by shoulder. Additionally, a large brown spot on opposite shoulder from injection. Very sore arm for 3 days unable to lift it .
68 2021-02-27 tremor Fever 99.9 and shaking, after that 102.7 fever and tiredness.
68 2021-02-27 night sweats Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom ... Read more
Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom the last 3 days on hands and knees. Lethargic . Tired. Fatigue. 4 days now. And I am getting worse. Heaviness on chest
68 2021-02-27 pain in extremity Several hours after injection my arm hurt down to almost the elbow. Not bad. Next day same until a... Read more
Several hours after injection my arm hurt down to almost the elbow. Not bad. Next day same until about 3:30 and I started to get chills, body aches and pains then nausea and headache. Shivering for 4-5 hours under the covers in bed with extra blankets and clothes. Can?t say I?m overly concerned as searching online I?ve seen reports of similar reactions but best to report. Today feeling a bit better, not shivering but still achy but not as bad and still a little nauseous.
68 2021-02-27 tremor chills, shakiness, shortness of breath, body aches
68 2021-02-28 weakness Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injecti... Read more
Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injection was on Friday and Saturday we woke up with the side effects. Sunday we were much better and Monday better.
68 2021-02-28 weakness Palpitations, weakness-cleared by EMS
68 2021-02-28 pain in extremity pronounced swelling under left arm - lymph node. achiness. some discoloration. slight swelling under... Read more
pronounced swelling under left arm - lymph node. achiness. some discoloration. slight swelling under right arm (site of 2010 lumpectomy, with sentinal lymph node removed, so less swelling). swelling and achiness reduced but still present 1 week later.
68 2021-02-28 tingling the lumpy, red area is not itchy, but it is tingling, and stings sometimes.; stings; lumpy, red area... Read more
the lumpy, red area is not itchy, but it is tingling, and stings sometimes.; stings; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the right upper arm on 25Jan2021 at 11:30 at a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included Influenza vaccine in Dec2020 and Balance of Nature Fruits as supplement since Jan2021 - she started taking Whole Foods brand Balance of Nature Fruits pills and has been taking them off and on for the last couple weeks. On 27Jan2021, the patient had a lumpy, red area on the opposite shoulder from where she received the COVID-19 vaccine. She said she discovered the lumpy, red raised up bumps area on her left shoulder that morning. She said the lumpy, red area is on the back of her left shoulder, neck and hairline area. She said her husband said the lumpy, red area is a couple square inches in size. She said the lumpy, red area is not itchy, but it is tingling, and stings sometimes. She also asked if what she is experiencing is a side effect of the vaccine. The patient declined any treatment for the events saying she didn't know what to do. The event "lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder" had not resolved while the outcome of the rest of the events was unknown. Information on the batch/lot number has been requested.
68 2021-03-02 numbness, tingling 3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face... Read more
3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face, and then some "rubbery" weakness in my arms and legs. Treated in an ambulance at vaccine site with IV Benadryl, had some skin tingling, also given IV solumedrol and observed for almost 2 hours with no other symptoms. I was also hypertensive, probably due to anxiety.
68 2021-03-02 weakness, discomfort Intense pain in lower back and right hip and pain down my legs (all weak and vulnerable areas where ... Read more
Intense pain in lower back and right hip and pain down my legs (all weak and vulnerable areas where I have issues now and then). It is bothersome to the point that I cannot find a comfortable position to relieve the pain. It feels like my lower body is being seized up, so to speak. The only way I can sleep is to take 2 Aleeve PM tablets. I take regular Aleeve throughout the day to take the edge off the pain. The reason I suspect it is a side effect is that a year ago I took the new Shingles 2-dose vaccination. I had this same reaction after taking the first dose - and it occurred about 2 weeks after that shot.
68 2021-03-02 cold sweat, weakness she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it... Read more
she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it was going to fall off it hurt so bad; she has ran a temperature and that finally broke but the highest was 102.4; She has been so weak she hasn't been out of bed hardly.; tired; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9265), via an unspecified route of administration from 29Jan2021 14:45 (2:45 PM) at single dose on right arm (as she was left handed) for COVID-19 immunization. Medical history included COVID (recovered) on an unspecified date. There were no concomitant medications. No additional vaccines administered on same date of Pfizer suspect. Patient previously got her flu and shingles shot at the end of "October". Patient took the vaccine last Friday (29Jan2021) at the age of 68 years old (reported as "68 and a half"). She does not know if that makes a "different" but her right arm felt like it was going to fall off it hurt so bad, on a scale of 1-10 it was about a 20. It was really tender she put a heating pad on it, she has been sleeping on the heating pad and it was mild now. It was only about a 3 now and it has come down, but it hurt like the dickens. Also she has ran a temperature and that finally broke but the highest was 102.4. Patient has slept around the clock and she has not been out of bed but like 30 minutes out of the last 24 hours (hrs) just to go the potty or drink something. Patient stated "almost gave up holding it was so long". She has been so weak she has not been out of bed hardly. Patient said that she has eaten since, "lets see Saturday night, Sunday, Monday". Patient has not eaten since Saturday night (30Jan2021) or gotten out of bed. She has not eaten anything. Patient has had COVID and recovered so she did not want to catch that again. She confirmed that she had COVID prior to received the vaccine. She called her primary care and she has a viral phone call tomorrow or visual phone call, whatever its called, she was trying to get over this mess, she feels warm, she was not registering a temperature right now but she had a cold sweat or something right now (01Feb2021). Patient has a call with him tomorrow so he will know about this incase Pfizer calls. Patient stated that she knows with a normal vaccine she might have an ache or something but this one hurt bad, maybe they pushed it in too hard or something she does not know. When asked for vaccination facility type, the patient answered that they had a vaccine clinic they had set up there in a conference room, they had an elaborate set up, go through certain places and there were several steps. Vaccine was not administered at facility (reported as "No hospital"). Patient further reported that her arm on 29Jan2021 (Friday evening) was tender. Patient lives by herself, she came home and does not know if she event ate. All she knows was she was real tired that Friday evening, it was tender and it got worse. Events did not require emergency room and physician room visit, reported as "Not to date but tomorrow she does not know if he will have her come in unless she spikes another fever or if he will do anything she may just ride it out". When asked for adverse events prior vaccinations, the patient answered "no none that she can remember. Sometimes she will have a sore arm that is why she gets it in the right arm because she is left handed thinkin her dominant hand will not have any problems but this one hurt really bad. Have they had many calls where this is really effecting arms really bad?". Patient also reported that her sister had the shot the same day and her arm was a little sore but that was all, she does not have NDC lot expiration for her sisters dose of the vaccine. She went to a different facility in a different location. Outcome of "her right arm felt like it was going to fall off it hurt so bad" was recovering, while for other events was unknown.
68 2021-03-02 tingling, numbness tingling on left side of face. Evaluated by EMS-Cleared
68 2021-03-03 bell's palsy Bell Palsy; This is a spontaneous report from a contactable consumer (patient) reported that a 68-ye... Read more
Bell Palsy; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration on the left arm on 17Feb2021 11:30 at a single dose for covid-19 immunization. The vaccine was administered at the hospital. Medical history included blood pressure, cholesterol, and gastrooesophageal reflux disease (GERD); all from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medications included benazepril, oxybutynin hydrochloride (OXYBUTININ ACCORD), ezetimibe, fenofibric acid, and esomeprazole; all were taken from an unspecified date for an unspecified indication. The patient experienced facial numbness then the patient went to the ER and was diagnosed with Bell's palsy on 17Feb2021 16:00. The patient underwent lab tests and procedures which included computerised tomogram: unknown result on an unspecified date. Therapeutic measures were taken as a result of bell palsy. The outcome of the event was not recovered.
68 2021-03-03 pain in extremity Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with... Read more
Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with Pioglitazone 15mg PO on 10/5/2018. Patient called study team stating that she received her second Pfizer COVID-19 vaccination on 02/19/21. Afterwards, she had a sore arm and slept most of the next day. On 02/21/21, she experienced severe right-sided leg weakness and fell while attempting to go to the bathroom. She was unable to ambulate and her son took her to the emergency room. She was hospitalized overnight for a serious adverse reaction to the second Pfizer COVID-19 vaccination. Multiple sclerosis exacerbation was ruled out after extensive testing. Then, she was transferred a Rehab facility on 02/22/21 for physical therapy and occupational therapy. She continues study medication without any missed doses. She will most likely be in Rehab for another week. She was able to walk 80 feet on 2/25/2021 with a walker and gait belt and ambulatory assistance. This is unrelated to study drug. We consider this to be a Non-UP SAE. As of 3/4/2021 the patient is still in rehab.
68 2021-03-03 pain in extremity chills; very fatigued; sore arm; This is a spontaneous report from a contactable consumer (patient).... Read more
chills; very fatigued; sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration on left arm on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient got her second shot of COVID vaccine yesterday, 01Feb2021, and was asking if she was infectious to anyone. She had some chills, was very fatigued and was a having sore arm. The sore arm started last night (01Feb2021) and when she woke up this morning (02Feb2021), she was with the chills and fatigue. The patient stated that they could be related to the fact that she got up at about 3:00 in the morning. The outcome of the events was not recovered.
68 2021-03-04 flushing, difficulty speaking 30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient w... Read more
30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient was coughing and clearing throat. Fluids were offered and patient was moved to a more private area, vitals were taken. Pulse ox 96% RA, blood pressure was elevated, HR was 86 bpm. Rapid response team was notified and took the patient to the hospital's emergency department.
68 2021-03-04 weakness, difficulty speaking 6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint ... Read more
6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint pain and stiffness., muscle soreness. Noticed voice hoarseness. Attempted to sleep after taking Advil with nightmares and restlessness. Felt this overall feeling of crying and uncontrolled sobbing. I had COVID in May of 2020 with hospitalization, Remdesivir IV. Pneumonia . July I was feeling better with noted Shortness of Breath not brought on by activity. I was able to resume my exercise activity. I walked but no longer able to walk 3-4 miles per day. I am walking 2 miles w strengthening exercise. The headache comes and goes with the addition of Advil and Tylenol alternating takes the edge off. I take a Zyrtec but it does not help
68 2021-03-04 weakness Dizziness and weakness started the morning after vaccination, and gone by that late afternoon Treate... Read more
Dizziness and weakness started the morning after vaccination, and gone by that late afternoon Treated with not moving and laying down
68 2021-03-04 tingling Guillain-Barre syndrome; achy arm; tingling sensation from head to toe/whole body was tingling/weird... Read more
Guillain-Barre syndrome; achy arm; tingling sensation from head to toe/whole body was tingling/weird and scary on and off sensation; This is a spontaneous report from two contactable consumers (patient's cousin and patient herself). A 68-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration in right arm on 10Feb2021 10:30 AM at a single dose for COVID-19 immunisation. Medical history included anxiety. It was reported that the patient was "physically fit. She was thin and was about 5 feet." Ongoing concomitant medications included escitalopram (reported as "generic Lexapro") for anxiety, calcium, and multivitamins. The patient previously received flu vaccine in Oct2020. She also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) via an unspecified route of administration in left arm on 20Jan2021 10:30 AM for COVID-19 immunization and felt a little soreness in arm and light headache the same day. Two nights later, her scalp felt on fire and had tingling sensation in her face for three weeks. A week after the first dose, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put her on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation and noticed some spikes in her blood pressure. Her physician told her to take another 2.5 mg amlodipine if needed. After her second dose, she went to sleep with achy arm. she woke up that night with a tingling sensation from head to toe. Her whole body was tingling. It was a weird and scary on and off sensation. She stated it had improved during the past two days. The patient confirmed that she had no heart rate problems. She actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. She mentioned her 97-year-old mother and husband both got the two doses with no complication or reactions. The patient's cousin was "pretty sure that it's Guillain-Barre." The patient stated the Guillain-Barre syndrome has not yet been confirmed. She had an appointment with a neurologist. The outcome of 'tingling sensation from head to toe/whole body was tingling/weird and scary on and off sensation' was recovering, of remaining events was unknown.
68 2021-03-04 numbness Numbness in lips and face on left side, same side as injection
68 2021-03-04 pain in extremity Right elbow became inflamed, red, warm and painful. Right upper arm was sore. Became dizzy at 11 A... Read more
Right elbow became inflamed, red, warm and painful. Right upper arm was sore. Became dizzy at 11 AM on 3/2 and slept for 3 hours. All expect the inflamed elbow were not a surprise. I treated my elbow with an ice pack during the day on 3/2 and by 3/4 it had improved. By 3/5 it was no longer inflamed, red or warm, but is still tender to lean on. I informed my doctor's office of this.
68 2021-03-04 tingling Right hand tingling and left hand itchiness/redness 20 minutes after vaccine. After vitals taken, le... Read more
Right hand tingling and left hand itchiness/redness 20 minutes after vaccine. After vitals taken, left hand tingling resolved. PO Benadryl 25 mg given. BP 147/80 (pulse 80), then 151/82 (pulse 78).
68 2021-03-04 cold sweat Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseo... Read more
Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseous. Didn't last long. Wiped my face and upper body with washcloth soaked in cool water for relief. Messaged my cardiologist and internist but haven't gotten response yet.
68 2021-03-04 pain in extremity pt stated that she had a sore arm and low grade fever the night after receiving the 2nd dose of the ... Read more
pt stated that she had a sore arm and low grade fever the night after receiving the 2nd dose of the covid vax. She started having vision problems about an hour after receiving the vaccination. She stated that her vision is blurry and she has to blink a lot so she can see anything. Today 3/5/2021 the only symptom she is having blurred vision. Pt will contact her PCP if her symptoms persist.
68 2021-03-04 tingling, pain in extremity week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pres... Read more
week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pressure; felt a weird sensation; Tingling in her head and her face; pain in the head and got increasing worse/scalp felt on fire/light headache; scalp felt on fire; she felt a little soreness in arm/12 hours my arm hurt; This is a spontaneous report from a contactable consumer (patient's cousin). A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/Lot number: EL9262), via an unspecified route of administration on the left arm, at age 68 years first dose on 20Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included ongoing anxiety from an unknown date. Ongoing concomitant medication included escitalopram 5 mg for anxiety, calcium and an unspecified multivitamins. The patient had flu vaccine in Oct2020. Patient's cousin called on behalf of cousin and reported that patient was very ill for having severe reaction to the COVID Vaccine. Patient was physically fit and thin received first dose of COVID vaccine on 20Jan2021, 10:30 AM. After her 1st dose, she felt a little soreness in arm, 12 hours her arm hurt and light headache the same day. Patient went to bed a little earlier than normal and slept a little longer since she was 69 years, its her body and it needed more sleep and woke up at noon and her arm was fine and very grateful to have the shot. Two nights later, on 22Jan2021, patient woke up in the middle of the night with tingling and pain in the head and got increasing worse, her scalp also felt on fire and had tingling sensation in her face for 3 weeks. Then, a week after the 1st dose on 27Jan2021, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation on an unspecified date and as she noticed some spikes in her blood pressure, her MD told her to take another 2.5 mg amlodipine if needed (once or twice a day as needed). She confirmed she had no heart rate problems but she actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. The outcome of the event 'eek after the 1st dose, her blood pressure went up to 210/101/noticed some spikes in her blood pressure' and 'tingling in her head and her face' was not recovered, for event 'she felt a little soreness in arm/12 hours my arm hurt' was recovered on 21Jan2021, while for the other events, it was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187054 same patient/drug, different event
68 2021-03-07 pain in extremity Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to proces... Read more
Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to process thoughts logically. Arm somewhat sore, but not horrible. This lasted until I went to bed Friday night at 11:00 PM
68 2021-03-09 pain in extremity Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of p... Read more
Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of pain in toes and tiredness; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318) via an unspecified route of administration on 02Feb2021 at 16:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included pancreatic cancer. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included levothyroxine; pancreatin (CREON); famotidine; latanaprost; and calcium carbonate, vitamin b12, vitamin D (CALCE) from unknown dates for unspecified indications. The patient did not have any known allergies. On 03Feb2021 at 18:00 around dinner time, the patient started with gastrointestinal issues and also had occasional "zaps" of pain in toes and tiredness. These lasted into Saturday night (06Feb2021). The patient did not receive any treatment for the events. The outcome of gastrointestinal issues, zaps of pain in toes, and tiredness was recovering. It was also reported that the patient had not been tested for COVID-19 after the vaccination. No follow-up attempts are needed. No further information is expected.
68 2021-03-11 feeling hot Client received the first dose of her Pfizer COVID-19 vaccine and during the post-vaccination wait p... Read more
Client received the first dose of her Pfizer COVID-19 vaccine and during the post-vaccination wait period, she complained of feeling warm, palpitations and tightness in the chest. ?911? was immediately called. She denied any itching or difficulty breathing and stated that she has a history of allergies as well as hypertension, for which she takes Lisinopril, 30mg and Lasix, 40mg. She also indicated that prior to coming in for the vaccine, she took some steroids and antihistamines at the suggestion of her primary care physician. Vital signs were as follows: BP=174/100, Pulse=111. A recheck of her BP was 200/110. The EMT ? responded to the call. They evaluated the client, treated her with an EpiPen and started an IV line. At 11:15, she was transported to the hospital.
68 2021-03-15 pain in extremity Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on m... Read more
Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Arm was sore; Had light headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken daily. The patient experienced light headedness and pressure in her chest that went to her left shoulder and jaw. Patient had light headache, pain in chest, and pain in jaw. She woke up this morning feeling better but still had slight pain in jaw. Wondering if side effects are from vaccine and will she be ok. Patient stated, "I have the first dose of the vaccine on 22Jan2021, I didn't have any side effect, my arm was sore but nothing big. But yesterday I feel light headed, like pressure in my chest, kind of pressure on my jaw and shoulder, my left shoulder, and my vitals were okay like my blood pressure, my heart rate and everything was normal. Further she explained this morning I felt better I didn't have pressure on my chest or anything but the pressure on my jaw that go up to my head. Is that related to the vaccine or is something that I have to worry about?" Consumer stated, "The second one is going to be on 12Feb2021, this Friday." Patient stated, "No, I was calling because today I feel better, I don't have the pressure on my chest. But I still have the pressure on my jaw and on my kind of my head. But no I have not called anybody. It's not like an emergency, I am calling because I was not sure about this is related to the vaccine." For treatment consumer stated, "No, today I took some Tylenol, that's all." No investigation assessment. The outcome of the event 'Light-headed' was recovering, the patient recovered from the event 'Pressure in my chest' on an unspecified date, was not recovered form Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head and was unknown for other events. No follow-up attempts needed. No further information expected.
68 2021-03-16 facial paralysis, bell's palsy Got COVID shot March 3, then had some alteration of taste around March 8 or so, then L facial paraly... Read more
Got COVID shot March 3, then had some alteration of taste around March 8 or so, then L facial paralysis consistent w Bell Palsy on March 11.
68 2021-03-16 tremor, burning sensation, flushing, tingling she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; bu... Read more
she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; burning and itching with bleeding; swelling in lips; Blood in stool/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Blood leaking around rectum/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Face and Neck Burning/hot face and neck was flushed; hot face and neck was flushed; Tingling in tongue, lips, face; Tingling in tongue, lips, face; throat felt tight; lips were puffy; thought she was starting to shake; anaphylactic event; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration in left arm (left shoulder area) on 06Mar2021 17:45 at SINGLE DOSE for COVID-19 immunisation. The patient had no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccination within 4 weeks. Medical history included upset stomach after eating banana's last year (2020). There were no concomitant medications. The patient had no family medical history relevant to events. The patient previously took bactrim and pneumonia vaccine and experienced anaphylactic reaction to both. On 06Mar2021, the patient experienced anaphylactic event, allergic reaction, face and neck burning, hot face and neck was flushed, tingling in tongue, lips, face, swelling lips, throat felt tight, and lips were puffy. On 07Mar2021, the patient experienced rash, blood in stool, blood leaking around rectum, burning and itching with bleeding. The patient further reported that she had a 'serious life threatening event' after first dose of the Pfizer Covid 19 vaccine on 06Mar2021. Hospital papers say 'anaphylactic event.' Tingling in lips tongue and face, hot face and neck after vaccine, swelling in lips, rash started yesterday evening (07Mar2021), bloody stools for a few hours yesterday evening (07Mar2021) but has resolved. The patient was seen in emergency room (ER) via ambulance. The patient asked if there was a chance the preservative in the vaccine caused her reaction and if the potassium in the vaccine causing her anaphylactic reaction. Additionally, the patient reported that she had a severe allergic reaction this past Saturday to the Covid Vaccine, stated the nurse sent her back to the pharmacist who told her she was having an allergic reaction to the vaccine. The patient reported having a hot face and neck was flushed, after the vaccine, she stated she had tingling in her tongue, lips, and face. And she stated her throat felt tight also, her lips were puffy, and a lot of heat of neck and face, thought she was starting to shake. The patient reported the pharmacist gave EpiPen in thigh and 20 mg tablet of Benadryl and called 911, and took her to the local hospital. Patient also reported that she has not seen this doctor yet she asked to see her and has an appointment with her. The patient also stated that her new PCP was not aware of the reaction to the vaccine at this time. The patient further mentioned that she was still having a rash that broke out. She reported that her tongue was tingling and she still has some swelling in her lips. Patient continues to clarify she still has swelling and some tingling on the tip of tongue and half back on her tongue. She stated that the swelling was persisting and that Benadryl or Prednisone does give some relief but it comes back. Patient mentioned being on a 4 day cycle of Prednisone, takes two in the morning with food. The patient clarified the location of the rash as a rash on both arms that was inside of both of the arms, like a pink rash, she states it was on face and on knees around the front and back of her knees like a red rash. She continues it was on the neck down to the collar bone around the back of her neck, like if she was a bust statue it would be all in that area from the collar bones at that point up and around the back of the shoulder blades. It goes all the way around face and neck. Patient also further reported that she had a scary reaction last night (07Mar2021), she said she had blood in her stool, leaking blood around rectum and it had like a burning itch, when she wiped it was blood, she continued to say when she wiped it was like 'giblets.' She stated was stool, blood, and giblets. Patient stated this lasted for about and hour and half or 2 hours until the stool stopped and it was about 1:30 am before she finally went to sleep, she was so tired on an unspecified date. She stated she took Benadryl right away. She continued to report the bleeding has resolved completely as of this point and reported a regular bowel movement today (08Mar2021). She has two Epi Pens from the drug store that was prescribed but she was afraid to use it, and she thought to see what happens if she uses the Benadryl. She received the Epi shot at the drug store, at (pharmacy), when her reaction broke out, on 06Mar2021, in her thigh, for the allergic reaction. This was her first time ever receiving EpiPen (Lot 029F20AA, expiration Mar2022, and NDC is 0093-5986-27). The ER doctor prescribed her 0.3 mg every 5-15 minutes as needed for anaphylaxis, and not to exceed 3 doses. She received the Benadryl at the drug store, 120mg tablet, first dose was given at drug store. Patient reported she was given prednisone IV in hand through IV at ER, she doesn't know how much that was, then was given Prednisone to go home with- 20mg tablets take 2 a day for 4 days, which she started Sunday morning, 07Mar2021. She was told she experienced a life threatening allergic reaction. Patient was taken to the ER in the ambulance, the paramedic who was with her said she was his first COVID reaction patient. ER doctor told her not to take the second dose of Pfizer vaccine, and to be cautious if taking the EpiPen, she states her heart was racing because of the EpiPen and was told it was because she was not younger that her body did not handle the Epi like younger people do and was told she could have a heart attack from the EpiPen. She was scared because she was not covered fully, since she can't get the second shot of Pfizer, and she was afraid of the Epi Pen, so she was really in a tough spot. ER doctor stated she may be able to take the Johnson and Johnson vaccine, as the second, but she needs to talk to her Primary care about that. The ER doctor continued to tell her it would have to be a special case where she was in a hospital setting in case she has another serious reaction, she was concerned for not receiving the second dose because that means she was not completely covered with one vaccine. She was afraid of the Epi-Pen since she can get a heart attack from it because of her age. The patient mentioned she was tested in Oct (clarified as 14Oct2020) for Covid due to having a viral infection at that time but was negative. Added the ER paper work says ED anaphylaxis. The patient wanted to ask about finding out the ingredients in Pfizer vaccine and the ingredients in the Johnson and Johnson vaccine. She saw the list on the fact sheet of Pfizer's ingredients and in a few places it says Potassium, 3 different ingredients, and several months ago, she quit eating bananas, bananas have potassium, and they were giving her stomach upset, diarrhea, she used to eat them all her life, she noticed that there was a lot of potassium in the medicine. Doctor wanted to know if she would be able to take the Johnson and Johnson vaccine. He said if she got the second shot, of the Johnson and Johnson, that it would have to be a special case, like in a hospital setting, and there would have to be medical people in a medical center, to take care of her was she has a reaction to it as well. He advised that she take the Johnson and Johnson than not taking it, because by not taking it, she was very vulnerable to catching COVID 19. And patient wanted to know was it a preservative that was causing the reaction. It was reported that rash began around 10PM, bloody stool began between 11 PM and 12:30 AM, all other symptoms within 15-20 minutes, it began around 6PM, maybe sooner 5:55 PM, she was in denial, it felt like tongue and lips tingling, she did have a reaction before to a different shot. The anaphylactic reaction required emergency room visit. Patient was not hospitalized and was in observation in ER. On 08Mar2021, the patient recovered from blood in stool, rectal bleeding, and burning and itching with bleeding. The patient had not yet recovered from severe allergic reaction, hot face and neck was flushed, tingling in tongue, lips, face; lips were puffy, and rash. The outcome of throat felt tight, thought she was starting to shake, she was so tired, and swelling in lips was unknown.
68 2021-03-17 weakness a significant headache this morning with pain focused at the front of her head; Weak feeling; feelin... Read more
a significant headache this morning with pain focused at the front of her head; Weak feeling; feelings of weakness in her legs when walking; sore throat; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) solution for injection, intramuscular on left deltoid on 26Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication was reported as none. The patient received the first dose of COVID vaccine on 26Jan2021 and reported a significant headache this morning with pain focused at the front of her head after she was up for a while, she also had a weak feeling, feelings of weakness in her legs when walking and a sore throat, all on 02Feb2021. Her headache was very bad, but after treating with 2 tablets of extra strength paracetamol (TYLENOL) 500 mg, her headache was not as bad as it was. This happened suddenly. Her sore throat started the same time as the headache which was currently gone. She wanted to know if these events could be from the vaccine, a week later; if she should get a COVID test; and how long will the headache last if it came back. The outcome of the headache was recovering and recovered on 02Feb2021 for all other events.
68 2021-03-18 pain in extremity Initial injection slight pain; I could not raise my left arm, very sore; I could not raise my left a... Read more
Initial injection slight pain; I could not raise my left arm, very sore; I could not raise my left arm, very sore; my hearing felt like I was in a bubble, continued to walk slow to my car still felt like head in a bubble; feel slightly dizzy; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 (Lot Number: EN6201) as single dose for covid-19 immunization. Medical history included sulfa allergy (reported as sulfa based) from an unknown date and unknown if ongoing. Concomitant medications reported as in two weeks included unspecified allergy nasal spray. The patient previously took codeine and experienced allergy. On 12Feb2021, at 13:00, the patient experienced initial injection slight pain; I could not raise my left arm, very sore; my hearing felt like I was in a bubble, continued to walk slow to my car still felt like head in a bubble; feel slightly dizzy. There were no treatments provided for the events, and no noted COVID testing post vaccination. The outcome of events was not recovered.
68 2021-03-18 inability to speak She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vacci... Read more
She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vaccine, got up from that and had dry heaves, lost her speech and had loose stools. The aide caught her as she was fainting as she would have fallen on the floor. She said it was weird, she looked at people and it looked like they were 2 dimensional and knew something was wrong, but couldn't figure out what as they attended to her. They asked her questions, but she was not able to speak to them. They apparently spent 2 hours with her, but she doesn't believe it was that long, and then they knew she wanted to go to one Hospital and not the other. She had been loosing words before this happened, but not as bad as this one. This was about the same reaction that she had when she got the COVID virus in January. She was then taken to the hospital where she was given fluids and hydrated her and checked her heart, saw a cardiologist and a neurologist to see if those things caused the fainting and had blood work done. They also did a CAT Scan of her head and neck. They told her that she was fine and was discharged back home after 5 days, which was 3/11/21. Since then she has been very tired, she does have GERD and her stomach has been hurting a lot as well.
68 2021-03-20 muscle spasms cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up... Read more
cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up; stayed in the bathroom, you know I was just dribbling sometimes; This is a spontaneous report from a contactable consumer for herself. A 68-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269, Expiration date: Unknown) on 08Feb2021 via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history included cholesterol and thyroid from an unknown date and unknown if ongoing. The patient's concomitant medications included vitamins. The patient stated she took medications for her thyroid and cholesterol, and vitamins. On 08Feb2021 at 19:30 the patient had cramping "real bad." The patient was sick all night, had chills, stayed in the bathroom, "you know I was just dribbling sometimes and hurting." The patient could not keep the Tylenol down, it came back up. There was no investigational assessment. The reporter stated she had her first dose of vaccine "yesterday" about 11. The patient was told that the second dose would probably make her sick, but "last night" at about 7:30 she started cramping "real bad," was sick all night, had chills, and just "now" really feeling quite normal. The patient asked if "this in anyway could have affected her kidneys." The patient stayed in the bathroom and "was just dribbling sometimes, was getting normal then she just dribbling and tried Tylenol (taken as treatment) but could not keep the Tylenol." The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
68 2021-03-20 nerve pain she developed shingles on the opposite arm of the vaccine arm; she is in a lot of nerve pain.; This ... Read more
she developed shingles on the opposite arm of the vaccine arm; she is in a lot of nerve pain.; This is a spontaneous report from a contactable consumer via medical information. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number : EK9231; expiry date : Apr2021) via an unspecified route of administration, in Arm Right on 05Jan2021 10:00 as single dose for protect against covid. The patient medical history and concomitant medications. The patient previously took mortin and had allergy ongoing, influenza vaccine (Flu shot) and had pain (She got a Flu shot 3 years ago in her left arm and the pain didn't go away for 9 months. States that for the next 2 years she got her flu shot in the right arm). Patient had the 1st dose on 05Jan2021, and was due next Friday for her 2nd dose, but she has come down with shingles on her opposite arm on 11Jan2021. She doesn't know if it has anything to do with the vaccine. Has it been reported before, and can she get the 2nd dose. Shingles was reported as worsened. She has shingles on the left arm, hand, wrist, and fingers; she was in a lot of nerve pain in Jan2021. The pain started 6 days after she got the vaccine; pain and tingling. Then 2-3 days later, she noticed some red marks by her elbow. She went to a clinic and was diagnosed with Shingles and was started on Valacyclovir 1gm tablet, 1 tablet 3 times daily for 7 days. The next day she called the doctor, and had a tele-visit and the doctor was able to see some lesions. She told the doctor how much pain she was in, so the doctor prescribed Gabapentin 100mg. She was told to start off with 1 daily at night to help with sleep because she wasn't sleeping because the pain was so bad, then after 5 days she can take 1 twice daily as needed. States that it hasn't been 5 days yet, so she was still only taking it once at night, and she was able to sleep over 4 hours at a time, which was great. She wishes she could jump ahead and start taking it twice a day already because she was in pain all day long, but she was following the directions. States that the pharmacist said she could take Tylenol in between, so that was what she is doing. States that she was getting more lesions, but they are faint and are mostly on the palms of her hands and in between her fingers. The outcome of the event Shingles was recovered 11Jan2021; for Nerve pain was unknown.
68 2021-03-21 pain in extremity Pain radiating from chest to left side of neck and left arm; Sore Swollen Lymph Nodes; Pain chest; A... Read more
Pain radiating from chest to left side of neck and left arm; Sore Swollen Lymph Nodes; Pain chest; Arm Pain, Left; Can't hardly use her left arm, it is so sore; This is a spontaneous report from a contactable nurse reported for herself. A 68-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9261, via unknown route on 12Feb2021 12:00 (at the age of 68-years-old) at left arm for COVID-19 immunization. The patient had not medical history. Concomitant medications were not reported. Vaccination Facility Type: Hospital. On 12Feb2021 the patient experienced left arm pain, pain chest, can't hardly use her left arm, it is so sore and on 14Feb2021 Pain radiating from chest to left side of neck and Swollen Lymph Nodes. Caller stated that she was thinking needs to go to the Emergency Room because it could be her lymph nodes, a blood clot, or her heart. She stated that she has been experiencing this since day one and nobody else has had side effects but her. She stated that this was out of the ordinary and according to the list she was given, it was not listed as a side effect. She was supposed to go tomorrow to get second shot, but she didn't think that she was going to be able to do it. No emergency room or physician office required. The outcome of the events at the time of last observation was reported as not recovered. Treatment was none. The events were assessed as serious, important medical events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-03-24 tingling Transverse myelitis acute rapid onset 3/22/21 with severe right lateral mid back pain, rapidly progr... Read more
Transverse myelitis acute rapid onset 3/22/21 with severe right lateral mid back pain, rapidly progressing lack of bilateral lower extremity sensation and rapidly progressing within hours to complete paralysis with fecal and urinary incontinence
68 2021-03-28 weakness body ache from head to toe; chills; sore throat worsening; sore throat worsening; fever of 101.8F; d... Read more
body ache from head to toe; chills; sore throat worsening; sore throat worsening; fever of 101.8F; dry cough; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number reported as "G or E N6202"), intramuscular in left arm on 27Feb2021 (age at vaccination 68-year-old) at 11.30 at single dose for COVID-19 immunization. She is due to take the second dose of the vaccine on 20Mar2021. Medical history included: she has history of AFIB but has been in regular rhythm and has not taken any medications since 3-4 years ago. Her blood pressure is so low and she was falling all the time, was dizzy and bumping into wall. The doctor said it was a good thing she is off. Her blood pressure is still 90's/60/s. She got shingles two shots and she got it last fall. Those were pretty awful. She had a lot of local tenderness, trouble lifting arm up and the next two days, she felt blah and had pain in clavicle and scapula on left side. That pain in the bone lasted about a week afterwards; diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, she has had low white cell all of her adult life (she has gone between 3.5 and 4.0). Family medical history: Cardiac history. Concomitant medication included: eye vitamins and that kind of stuff. She did not take Tylenol or aspirin two days prior. On 09Mar2021, 11 days after getting the first dose of the vaccine, she had symptoms namely sore throat, chills, body ache from head to toe, dry cough, fever and weakness. She said that it lasted for 36 hours. She felt so crappy on 09Mar she did not take her temperature. She did not take it until 10Mar2021 when it reached a maximum of 101.8 degrees. Patient said she now feels pretty good except she has no energy at times. She wondered if she had COVID, so she got a test on 10Mar2021 and it was negative. Patient reported that she actually had a sore throat for about a year. That may not have been started with the vaccine, but it may have been exacerbated. She thinks she may have Reflux. She made an appointment with her gastroenterologist. She said her throat was red when she went to Urgent care to get the COVID test. She has had a dry cough for about a year. That could be related as well to the reflux. That did not seem to increase since the vaccine. Reporter considered events fever, chills and ached from head to toe as medically significant. Outcome of events sore throat worsening, asthenia was not recovered, chills, ached from head to toe, fever was recovering, of event cough was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Fever, Ache, and Chills cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-03-29 tingling The tip of my tongue became numb and slightly tingly.; The tip of my tongue became numb and slightly... Read more
The tip of my tongue became numb and slightly tingly.; The tip of my tongue became numb and slightly tingly / around my mouth and on my cheeks became slightly tingly; around my mouth and on my cheeks became slightly tingly; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 (at the age of 68-years-old) as a single dose for COVID-19 immunization. Medical history included arthritis, anaphylactic reaction to shellfish (patient carried an epinephrine (EPIPEN). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included omeprazole and calcium carbonate/colecalciferol (VITAMIN D 2000). The patient did not receive any other vaccines within 4 weeks of the vaccination. The patient previously took ibuprofen and had an anaphylactic reaction (possibly) and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN9581) on 28Jan2021 at 09:00 (at the age of 68-years-old) in the left arm for COVID-19 immunization. On 24Feb2021 at 09:30, the tip of the patient's tongue became numb and sightly tingly. Also, around the patient's mouth and her cheeks became slightly tingly. This lasted about 45 minutes. The patient was not treated for the events. Since the vaccination, the patient was not diagnosed with COVID-19. The clinical outcome of "the tip of my tongue became numb and slightly tingly / around my mouth and on my cheeks became slightly tingly" was resolved on 24Feb2021 at 10:15.
68 2021-03-30 numbness, tingling Arms are weak, numb, tingly; Arms are weak, numb, tingly; Arms are weak, numb, tingly; Facial tingli... Read more
Arms are weak, numb, tingly; Arms are weak, numb, tingly; Arms are weak, numb, tingly; Facial tingling; Struggle to do anything with arms or hands; Struggle to walk; Exacerbation of MS following first dose of vaccine; Legs are weak, numb, tingly; Legs are weak, numb, tingly; Legs are weak, numb, tingly; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 04Mar2021 08:00 as single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history included multiple sclerosis from 1994 and ongoing Verbatim: MS. There were no concomitant medications. Historical vaccine included Tdap vaccine (DPT VACCINE) on 18Feb2016 for vaccination. The patient stated that she was looking for direction as well as reporting an exacerbation of MS following her first dose of the vaccine, clarified as the Pfizer Covid-19 vaccine, on 04Mar2021. Weight: Caller stated she would give her Covid weight. HCP: Caller reported that she is unsure of MD zip code. She reported that the phone number for her MD ends in DOCS but she did not know which numbers that corresponded to. Caller reported that she did not experience any of the common side effects from the first dose of the Covid-19 vaccine. She did not experience a sore arm, fever, muscle aches, none of that. She reported that she did not have any side effects until the afternoon of Saturday, 06Mar2021. Caller reported that she's had MS for many many years and that it has been in what she calls remission for a long time. She stated that the last exacerbation she experienced was following a Tdap vaccination five years before. Because of this experience, when the Covid vaccine came out, she went through her doctor to see what she should do, if she should get it. Her doctor recommended that she get the Covid-19 vaccine, but told the caller that she should make sure to go to a health care facility to receive it instead of drugstore or a clinic due to her experience following the Tdap vaccine in 2016. Caller reports that she is now having a similar exacerbation following the Covid-19 vaccine. Exacerbation of MS: Caller stated that it is an ongoing exacerbation that is not getting better. She stated that she's sure that it will get better, but she is not sure what she should do about the second dose. Legs weak, numb, tingly: Caller reported that the weakness, numbness, and tingling in her legs was progressive. She stated that the weakness, numbness, and tingling began on Saturday afternoon, 06Mar2021, in her feet and lower legs, and had then progressed to her thighs by Sunday 07Mar2021 or Monday 08Mar2021. Arms are weak, numb, tingly: Caller reported that she noticed on Sunday, 07Mar2021 that her hands were a little clumsy. She reported that throughout the day of Sunday, 07Mar2021 and Monday, 08Mar2021, the numbness and tingling progressed into her upper arm. Facial tingling: Caller originally stated that she has been experiencing a lot of nerve sensation, then clarified as facial tingling, in particular around the mouth, below the nose, and on both sides of her face. She stated that it began on Sunday, 07Mar2021 and was intermittently present on 08Mar2021 probably into 09Mar2021, then it just went away. She stated that it would come and go. Caller reported that while she is able to walk and has not had to use her wheelchair, that it is a struggle to walk. She also reported that it is a struggle to do things with her arms and hands. She stated that if she wanted to eat, in order to pick up the fork she would probably be using 2 hands to get the fork up but can use it once it's in her hands. She also reported that a pencil is difficult to pick up as well, stating that she would need to use both hands to pick it up but would be able to use the pencil once she had picked it up. Caller reported that the tingling comes and goes, and she experiences varying degrees of numbness. She reported that they are a little numb throughout the day and it may get worse depending on what she's doing. She stated that she isn't a sitter, she has to get up and move. Caller reported that she called her physician, about the side effects she was experiencing and they instructed her to go to the Emergency Room. She stated that their concern was what was going on and if it could be Guillain Barre disease, which she stated is extremely rare. Caller reported that when she went to the Emergency Room on 09Mar2021, they did not really do any tests. She stated that in order to see if there were any new lesions for the MS, they would have to do an MRI of her brain. Caller reported that they did not believe that there were any new lesions, that they thought it was old lesions. Caller reported that they told her to go home and make an appointment with the neurology resident clinic for that week, clarified as last week, week of 09Mar2021. Caller reported that she called the neurology clinic as she does not currently have a neurologist, and they informed her that they would not be able to get her in for an appointment until the end of Apr2021. She stated this was not doing her much good. Caller stated that they had wanted to admit her to the hospital, but told her that she could go home if she promised to follow up with the neurology resident clinic. Caller expressed some frustration, stating that she was really trying to reach out to see what she should do regarding the second dose. Her physician tells her to go to the Emergency Room, the Emergency Room tells her to go to neurology. She wants to know what will the second dose do. She stated that she called the (state) chapter of the national MS society this morning, where they informed her that they had not heard any reports of exacerbations from the Covid-19 vaccine. Caller states that getting additional doses of the Covid-19 vaccine is a lifelong decision. She stated that Covid may not always be a pandemic, but it could come back like a yearly flu. She stated that because additional doses of the Covid-19 vaccine could be required, she wanted guidance on how to proceed. Her second dose of the Covid-19 vaccine is scheduled for 25Mar2021. Clinical outcome of facial tingling was recovered on 09Mar2021, while for the rest of the events was not recovered. Information about Batch/Lot number has been requested.
68 2021-03-30 numbness, facial paralysis Her left arm and face were numb; mass/swelling on her face; The left side of her face is drooping; f... Read more
Her left arm and face were numb; mass/swelling on her face; The left side of her face is drooping; face became swollen; face became swollen and inflamed; face was still swollen and sore; This is a spontaneous report from a contactable consumer (patient) and a contactable nurse. This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208, expiration date: 30Jun2021) via intramuscular in the left arm on 12Mar2021 at 14:10 at single dose for COVID-19 immunisation. Medical history included hyperlipidemia, pneumonia and flu. The patient had family medical history of diabetes. Concomitant medications included estrogens conjugated (PREMARIN) ongoing. The patient was not pregnant. The patient no other vaccine in four weeks or other medications in two weeks. The left side of the patient's face became swollen and inflamed. Five days later the left side of her face was still swollen and sore. The left side of her face was drooping. Events started date was 12Mar2021 at 15:00 PM. No treatment for AE was received, except events "mass/swelling on her face" and "Her left arm and face were numb". The patient had no COVID prior vaccination, no COVID tested post vaccination. A nurse reported that the 2nd dose was scheduled for 05Apr2021. The patient had last blood work (reported as BW) on Sep2020 with comments: normal. The left side of patient's face was drooping on 14Mar2021. The nurse stated patient went to ER. Her left arm and face were numb. They noticed a mass/swelling on her face. Outcome of the events "mass/swelling on her face", "Her left arm and face were numb" was unknown, of the other events was not recovered.; Sender's Comments: A contributory role of BNT162B2 to event the left side of her face is drooping is considered possibly based on temporal association and known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-03-30 pain in extremity MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms... Read more
MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms left eye/decrease color discernment; poor vision left eye/vision from 20/30 to 20/60 corrected in left eye/decreased vision; This is a spontaneous report from a contactable physician. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198) intramuscularly administered in the right arm on 02Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included addison's disease, hypertension and optic neuritis from Aug2020 to Aug2020. Patient was not pregnant. Concomitant medications included hydrocortisone (HYDROCORTISONE), metoprolol (METOPROLOL), fludrocortisone (FLUDROCORTISONE), amlodipine (AMLODIPINE), estradiol (ESTRADIOL) and olmesartan (OLMESARTAN). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) intramuscularly administered in the right arm on 09Feb2021 02:00 PM as single dose for COVID-19 immunisation. On 03Mar2021 07:00, patient had multiple sclerosis (MS), optic neuritis, sore arm, overslept and fatigue. It was also reported that when the patient woke up on 03Mar2021 07:00, she had poor vision in the left eye and experienced color fading; further reported as washed out symptoms in the left eye. She went to the ophthalmologist and saw that she had decreased vision, further reported as from 20/30 to 20/60 corrected in left eye and decrease color discernment. Patient was treated with Methylprednisolone 250mg intravenous (IV) every 6 hours x 12 doses for the events multiple sclerosis (MS) and optic neuritis. The events resulted in physician office visit. The patient underwent lab tests and procedures which included CT angiogram: negative for arteritis on an unspecified date, fundoscopy: normal on an unspecified date, intraocular pressure (IOP): normal on an unspecified date, lumbar puncture: increased protein 79 ms panel pending on an unspecified date. Outcome of events was recovering.; Sender's Comments: The events most likely intercurrent conditions and unlikely related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198). This case will be reassessed when follow-up information is received.
68 2021-03-30 flushing, feeling hot blood pressure was checked and it had skyrocketed to 204/110; blood pressure had dropped to 95/58; s... Read more
blood pressure was checked and it had skyrocketed to 204/110; blood pressure had dropped to 95/58; she was lightheaded; feel chest pressure; facial flushing and warmth; facial flushing and warmth; redness on her neck and chest; This is a spontaneous report from a contactable retired registered nurse (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right deltoid on 06Mar2021 10:09 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for anaphylaxis prophylaxis; famotidine (PEPCID) taken for anaphylaxis prophylaxis; cetirizine hydrochloride (ZYRTEC) taken for anaphylaxis prophylaxis; methylprednisolone acetate (MEDROL) taken for anaphylaxis prophylaxis. The patient previously received H1N1 vaccine (Sanofi Pasteur, lot number: UP006AA, expiry date: 15Mar2011) on 27Oct2009 and experienced anaphylaxis. Patient had no other vaccines on the same day as the suspect product. The patient experienced blood pressure was checked and it had skyrocketed to 204/110 (hospitalization (from 06Mar2021 to 08Mar2021)) on 06Mar2021, felt chest pressure on 06Mar2021 10:29, facial flushing and warmth on 06Mar2021 10:29, redness on her neck and chest on 06Mar2021 10:29, she was lightheaded on 08Mar2021, blood pressure had dropped to 95/58 on 08Mar2021 21:43. Clinical course: Caller states that she received her first dose of the product on 06Mar at 10:09am. Caller states that to provide some history, in Oct2009, she had anaphylaxis from the H1N1 Vaccine and in 2017, she finally found an allergist who specialized in medication allergies. Caller states that since then, any time she takes the Flu Vaccine, she pre medicates with a combination of antihistamines and a proton pump inhibitor. Caller states that in preparation of the COVID vaccine, her allergist prescribed her a Medro Dose pack and antihistamines and a proton pump inhibitor for preparation, starting three days prior to the vaccine, in order to prevent anaphylaxis. Caller states that 20 minutes post receiving the vaccine, she started to feel chest pressure, she had facial flushing and warmth, and redness on her neck and chest. Caller states that her blood pressure was checked and it had skyrocketed to 204/110. Caller states that she did not have anaphylaxis though. Caller reports that with her blood pressure being so high, they had to call paramedics, and the caller went via ambulance to the ER at about 1130am on 06Mar2021. Caller states that she spent 6 hours in the ER, and then she was put in the hospital for the next two days. Caller reports she was admitted to the hospital for her blood pressure because the ER could not get it below 185 systolic. Caller states that all her labs were negative for everything, and they checked heart attack markers that were all negative. Caller had an EKG and a stress test and those were both negative as well. Caller had blood work done, EKG and stress test that were all normal. But caller states that it took a while to get her blood pressure down. Caller states that she was talking with her allergist and he said that if she gets the second dose of the vaccine, it would need to be in a hospital setting, with an IV already in place, and caller does not think insurance will cover all that. Caller states that she did speak with an Infectious Disease doctor, who told the caller that she needs to get the second dose of the product for COVID coverage, but how would the caller move forward with getting the second dose, following what happened to her? Caller is wondering how much protection the vaccine provides after just one dose? Caller is also wondering, the hospital gave her at least two or three doses of Solu-Medrol, and caller is wondering if having received steroids in the hospital would reduce the efficacy of the COVID vaccine, and if so, by how much? Event Details: Caller had the vaccine, and the reaction started on 06Mar2021, and she was admitted on the same day. Caller was discharged from the hospital on 08Mar2021 around 330pm. Caller reports that the morning of her discharge from the hospital, her blood pressure had gotten back to 135 systolic, but before it was time for her to go down for the stress test, it was back to 159, and down while she was in nuclear medicine, it got to 160 systolic. Caller reports that the day she was discharged, she went home and got settled in, and she took her blood pressure and it was down to 128/78, but then that evening, things got spinning around her, and lights were flickering in her head, and she was lightheaded, and her blood pressure was 110/63 at 9pm and by 9:43pm, her blood pressure had dropped to 95/58. Caller states that it has not been a fun trip. Caller reports that the next morning, her blood pressure was back up to 139/78, but then later in the day she was lightheaded again, and by 9am her blood pressure was 111/69. Caller states that since then, her systolic blood pressure has been between 110 and 126. Caller states that there is nothing else she can think of. Caller states that she felt fine the morning of getting the COVID vaccine, she was looking forward to getting it, and she got herself on the list and made sure to consult with her allergist so that she would have prophylactic medications ready to go. Caller states that she does have a history of hypertension, but her blood pressure was 128/72 the morning of getting the COVID vaccine. The outcome of the events Blood pressure high and Blood pressure dropped was recovering, of the other events was unknown. The reporter considered the event blood pressure had skyrocketed to 204/110 was related to the suspect vaccine.; Sender's Comments: Based on the temporal association and known drug safety profile, a possible contributory role of vaccination with BNT162B2 to the reported event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
68 2021-03-30 weakness sepsis; gallbladder attack; passed out from the gallbladder attack; Gets dizzy; Weakness; she was tr... Read more
sepsis; gallbladder attack; passed out from the gallbladder attack; Gets dizzy; Weakness; she was trying to gain her strength from being sick; her head hurt from the fall; her head hurt from the fall; she had to walk slower because she got dizzy; This is a spontaneous report from Pfizer. A 68-year-old female contactable consumer reporting for herself received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6200, expiry date Jun2021) on 16Feb2021 at 14:45, in left arm, for COVID-19 immunisation. The patient received the COVID-19 vaccine for age and several comorbidities. No other vaccines were administered within 4 weeks. Medical history included ongoing high blood pressure diagnosed 25 years ago, ongoing hypothyroidism diagnosed 25 years ago, liver resection in 2007 for a benign tumor (she had not been sick and it was found accidentally), liver bile duct stopped up from 2017 and ongoing (due to scar tissue from the liver resection surgery; she had an emergency stent placed in her bile duct), chronic Crohn's disease, ongoing thyroid disorder. The patient previously received flu vaccines on unspecified dates for immunization experiencing unspecified side effects some years ago, but this past year she didn't have a reaction. The patient previously received pneumonia shots on unspecified dates since few years. Family history included gallbladder problems in her sisters and mother. Concomitant medications included oral amlodipine (manufacturer: Lupin, expiry date: 23Feb2022) from an unspecified date (a few years ago) and ongoing, 5 mg at night, for blood pressure, oral telmisartan (MICARDIS; manufacturer: Alembic, expiry date: 02Mar2022) from an unspecified date (few years ago) and ongoing, 80 mg at night, for blood pressure, oral metoprolol (manufacturer: Mylan, expiry date: 09Feb2022), from an unspecified date (few years ago) and ongoing, 25 mg twice daily, morning and night, for blood pressure, oral levothyroxine sodium (SYNTHROID) from an unspecified date (20 years ago or more), 75 ug daily in morning, with water, hour before any eating or other medications, for thyroid disorder. The patient experienced sepsis on 25Feb2021 with outcome of recovered on 03Mar2021, gallbladder attack on 24Feb2021 with outcome of recovering, passed out from the gallbladder attack on an unspecified date in 2021 with outcome of unknown, got dizzy on an unspecified date in 2021 with outcome of not recovered, weakness from being hospitalized on an unspecified date in 2021 with outcome of not recovered, she was trying to gain her strength from being sick on an unspecified date in 2021 with outcome of unknown, her head hurt from the fall on an unspecified date with outcome of unknown. The patient was hospitalized for sepsis due to a gallbladder attack from 25Feb2021 to 03Mar2021. The events gallbladder attack and sepsis required also an ER visit. They did not require a physician office visit. Additional clinical course of the events included the following details. Gallbladder attack turned into infection/sepsis quickly. She previously had an emergency stent placed in her bile duct and now there was a stone in the bile duct and she was unsure if it was related; they will either remove her gallbladder or place a permanent stent. They removed stones and "goop" and placed a stent. Her gallbladder still needed to be operated on, but she was not sick with sepsis anymore. Regarding gallbladder attack the patient reported that it was controlled until further tests and surgery were performed. They couldn't do the surgery due to the infection which had cleared up but she did not want the surgery right now. A stent was placed in the duct until something was done and the stone will be crushed eventually. The patient passed out from the gallbladder attack. She never passed out, she had only ever passed out one other time in her 20's where she stood up too fast. The patient reported that she had to walk slower because she got dizzy and she was trying to adjust to getting home. She walked to the bathroom, used it, and her husband heard a thump while he was using the other bathroom. She was looking at the thermostat and fell in the den and she was surprised she didn't hit anything. Her head hurt from the fall. Sepsis: caller reported that as soon as she went to the ER, she was diagnosed with sepsis. Sepsis resolved the day she was discharged from hospital and when she was dismissed all tests were negative for sepsis. She went home on antibiotics for security for another week after discharge from hospital. Dizzy: it was just trying to get her strength up. She'll just be doing nothing and getting up too fast, it happened to any old person with blood pressure medicines. Dizziness began before she went into the hospital. She was experiencing weakness from being hospitalized and she was trying to gain her strength from being sick. Weakness began during her hospital admission and it was ongoing. On 03Mar2021 the patient underwent lab tests and procedures which included haematocrit: 30.4 %, haemoglobin: 10.4 g/dl (not in normal range yet), CMP: within normal limits (all results were within normal limits, including sodium and potassium), platelet count: 159, RBC count: 3.33 (supposed to be 3.9 or more but could have gotten better by now), WBC: 6.1 x10?/L, blood cultures: the results were not yet listed but sepsis was gone according to discharge blood work. She went to the doctor regularly. Her doctor knew how sensitive that was with her, but that her side effects were probably no more than anyone that experienced that. In some years she did not experience adverse events, specifically she did not with her flu vaccine in 2020. She has had side effects that had made her feel ill for 2-3 days and her niece was a nurse and thought she was making it up. The patient was advised to wait for the 2nd dose, she was unable to get it as scheduled on 08Mar2021. In meantime between receiving her first dose and her appointment for her second dose on 08Mar2021, she was hospitalized. The patient was just coming out of the hospital before 08Mar2021 and she still did not feel well so she cancelled the appointment. The hospital doctors, as well as the doctors approaching more tests with her gallbladder, recommended to not get the second dose as scheduled on 08Mar2021, but they could not recommend how or when to get it.
68 2021-04-06 tremor, migraine, feeling cold Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vo... Read more
Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vomitting fever severe trembling and chills. During the night nightmares and migraine woke me up. Tried to go to the bathroom but collapsed and knocked my head on the wall. Could not get up crawled to the bathroom and tried to pull myself up but fell headfirst and hit my nose and cheek on the toilet. Cut nose and hurt cheek bone. Felt terrible head spinning and unable to get up/ Crawled to bed; Live alone. Could not even find the telephone; Woke up and tried to get up. Freezing cold. Finally called Ambulance Their doctor refused to send an ambulance and said " go to your GP its not an emergency". I was disgusted barely could walk but somehow drove to the GP. he was closed so went to emergency. the Dr in charge of the vaccination center was there but did not accept it was the vaccine; Finally on the verge of collapse another lady took me to the entrance of emergency. I was finally seen:; Same thing. Dr there told me its not an emergency and to go and see my GP. I was so sick and told him th eGP was not there; His reply " There are plenty of others to see" It was the nurse who persisted and even thought may be I had covid and did the PCR test. I started uncontrollably shivering and was freezing. I had a fever. they did blood tests lung x ray and finally a urine test, Full of blood leucocytes and protein. The same wonderful nurse said its bad. I was by then vomitting again and thought I would die; Uncontrollable shivering ; taken to the lab or a pelvic cat scan;Couldnt even get to sip water. SEVEN hours later the same DR who told me I was not an emergency came in and said " You will have to be hospitalised as you have a serious kidney infection. Acute pyelonephritis. I vomitted on him! Taken to a ward 25 March until 29 March. Rocephin antibiotics. Allergy to that too with migraines and skin rash; They changed the antibiotics. After five horrible days I finally went home on antibiotics Ofloxacine
68 2021-04-07 weakness Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased... Read more
Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased level of care. Patient was admitted to outlying hospital with COVID-19 infection with shortness of breath, cough, fever, weakness, fatigue with decreased oral intake on 3/28/21. Patient required oxygen and was treated with remdesivir, steroids, and antibiotics. Patient was discharged to home with oxygen.
68 2021-04-08 nerve pain Was given 2nd shot March 22 and within 12 hours I had what I would call shooting nerve pain on t... Read more
Was given 2nd shot March 22 and within 12 hours I had what I would call shooting nerve pain on the level pain of shingles except it was everywhere. Next day I hurt all over. Wednesday some recovered, Thursday I went to work. Friday I would have said I was 100% till 3:30pm. I had adominal pain. Went to ER and was diagnoised with appendicitus. Had surgery next morning.
68 2021-04-12 weakness Patient presented with weakness and AMS. On admission, patient had severe hyponatremia and confusion... Read more
Patient presented with weakness and AMS. On admission, patient had severe hyponatremia and confusion continued as was also found to have supratherapeutic tacrolimus level. Patient started experiencing respiratory symptoms on day 2 of admission requiring O2 and treatment for COVID.
68 2021-04-21 pain in extremity Bitter, metal, tinny taste in mouth within one hour or less of vaccination. I am not sure of exact t... Read more
Bitter, metal, tinny taste in mouth within one hour or less of vaccination. I am not sure of exact time because we ate directly after the fifteen minute waiting period. I didn't notice the sensation until right after we ate. It lasted about three days and then was gone. It was strong enough for me to notice immediately and think how weird, and it was strong enough for me to notice it off and on the next three days-gradually lessening. I have also had a sore throat the whole week since the vaccination-it started the day after. It hasn't turned into a cold-maybe a little drippy nose occasionally so not sure if sinuses etc, but the sore throat is persistent. Occasionally I feel it up higher in the nasal-pharynx also. I didn't report to my doctor or treat in any way. And for statistics, my arm was sore for about two days. The worst was that evening and pretty mild after that.
68 2021-04-24 nerve pain appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain e... Read more
appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain except it didn't stay in one part of the body.; This is a spontaneous report from a contactable consumer (reported for herself). A 68-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199), administered in right arm via an unknown route of administration on 22Mar2021 at 09:00 am as SINGLE DOSE for covid-19 immunization. The patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6200), administered in right arm via an unknown route of administration on 27Feb2021 at 08:00 am. The patient medical history included blood pressure measurement. Concomitant medications in two weeks included Olanzapine 2.5mg, Olmesartan 20mg and Zetia 10mg. The patient had drug allergies for Codeine and Demerol. On 22Mar2021 within 12 hours, the patient started with nerve pain on the level of shingle pain except it didn't stay in one part of the body. The whole body was affected. Next day on 23Mar2021, the patient was sore and tired. On 26Mar2021 at 3:30 pm, the patient had abdominal pain and went to hospital at 09:00pm because of pain and was diagnosed with an appendicitis. The treatment for the events included appendectomy surgery to remove the next morning. There was no other vaccine in four weeks. On 26Mar2021, the patient was tested for covid with nasal swab post vaccination which was negative.The patient was hospitalized for 2 days for all the events. The outcome of the events was recovering.
68 2021-04-24 weakness chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any ... Read more
chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any Cardiac history; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; irregular heart rate and am going to have to more cardiac work up; extreme shortness of breath with minimal exertion; weakness; dizziness; very tired; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:15 (at 68 years old, not pregnant), single dose for covid-19 immunisation. Medical history included hypothyroidism, arthritis, all from an unknown date. The patient had her first dose of bnt162b2 for Covid-19 Immunization on Mar2021. The patient was taking unspecified concomitant medicines. The patient experienced within 5 minutes after receiving her second injection, she began having chest pain and palpitations. The paramedics ran a 4 lead EKG and she was experiencing consistent PVC's which is abnormal because she does not have any Cardiac history. She went to the emergency room and was noted to have a D-Dimer lab result of 758ng/ml as well as other abnormal labs. Still continue having PVC's and irregular heart rate and was going to have to more cardiac work up. Also have experienced other symptoms associated with actual COVID such as extreme shortness of breath with minimal exertion, weakness, dizziness, very tired. And muscle aches 2 days as of Friday 09Apr2021. All the events also reported as started 07Apr2021 14:15. The outcome of the events was not recovered. Treatment for the events was observation and medication. Patient was hospitalized due to the events for 1 day. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.
68 2021-04-24 one side paralysis, inability to speak stroke; R sided weakness; expressive aphagia; This is a spontaneous report from a contactable other ... Read more
stroke; R sided weakness; expressive aphagia; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 05Feb2021 (at age of 68 years old, no pregnant, Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included type 1 diabetes, hypertension (HTN). The patient not had COVID prior vaccination also not had COVID tested post vaccination. No known allergies. Concomitant medication included insulin, lisinopril and Multi vitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Jan2021 at 03:00 P.M. (at age of 68 years old, Batch/Lot number unknown) as single dose for covid-19 immunization. The patient received 2nd Covid shot on 05Feb2021. Had a stroke on 14Feb2021 at 08:00 AM with R sided weakness and expressive aphagia. Stroke noted on MRI in L hemisphere, speech area. The patient had no idea if this was related to the Pfizer Covid vaccine. AE resulted in: Emergency room/department or urgent care, Hospitalization (1 day), Life threatening illness (immediate risk of death from the event). Treatment received for events included observation, Lovenox. The outcome of the events was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Stroke, Weakness left or right side, and Expressive aphasia cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
68 2021-04-27 speech disorder, pain in extremity Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest;... Read more
Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest; nausea feeling in her chest; She gets this laryngitis; has trouble talking; She wants to make sure its not going into like a viral pneumonia; Flu-like symptoms; fever; achy; fatigue; Sore arm; Headache; This is a spontaneous report received from a contactable pharmacist (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: CER230) via an unspecified route of administration on 24Mar2021 at 11:30 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 immunisation. The medical history included flu and suspected COVID-19 both in Jan2020 to an unspecified date (she had a bad flu back in Jan2020, which could have been COVID because it was such a bad flu, over a year ago), ongoing asthma from an unspecified date (mild asthma) and chest nausea in Jan2020 to an unspecified date. The patient had no history of any adverse events following prior vaccinations. Medical history (including any illness at time of vaccination) was also reported as none. Family medical history relevant to the adverse event included an uncle that had asthma, but no one else had breathing issues. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR) and ipratropium bromide/salbutamol sulfate (DUONEB), both ongoing and taken for asthma on unspecified dates. Other products were also reported as "no". The patient did not receive any prior vaccinations within 4 weeks prior to the COVID-19 vaccine and did not receive any additional vaccines on the same date as the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: 3N6202) via an unspecified route of administration on 24Feb2021 at 11:30 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunisation. On 24Mar2021 the patient experienced sore arm and headache; on 25Mar2021 the patient experienced flu-like symptoms, fever, achy, fatigue; on 02Apr2021 the patient experienced asthma flare up, dry, hacky cough, pain and tightness in her chest, nausea feeling in her chest; on unspecified dates in Apr2021 the patient experienced she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia. The reporter classified the events headache and flu-like symptoms as non-serious. The patient called to report that she had an asthma flare up 10 days (as reported) after her second dose of COVID-19 vaccine on 24Mar2021. The patient stated that she did not get a flare up often, she had mild asthma. She usually got mild flare-ups since she did not have severe asthma. She stated it could be something else, but she had not had a flare-up like this since she had a bad flu back in Jan2020, which could have been COVID-19 because it was such a bad flu. That was over a year ago. She received her second vaccine on 24Mar2021, and the asthma flare up and hacking cough started on 02Apr2021. On the night of 24Mar2021, she started with a headache. She had the shot at 11 something and by that evening before she went to bed, she had a headache and a sore arm, but that was no big deal. Then on 25Mar2021, she started with flu like symptoms/fever. The headache persisted through that as well. At that point, she did not have tightness or the dry, hacky cough. By the middle of the day on 27Mar2021, her flu-like symptoms were gone. She would consider these to be "non-serious", it was what she expected, as it was seen from the paperwork of the vaccine. By 28Mar2021, all of her symptoms were gone prior to the flare-up. She had typical flu-like symptoms: fever, headache, achy, fatigue on the 2nd, 3rd, and into the 4th day but then they cleared up. By the evening of the 4th day, she started feeling fairly normal. She stated that they were mild flu symptoms. Her temperature was only 100 for about a day. She stated that that was expected. Then, she went into this flare-up about the 10th day after the vaccine. The first 3 or 4 days after the flare up began, the flare up was worsening. Then, she got it under a little bit of control, so she was not coughing all night and having to sit up as she was sleeping. Now, she was concerned about the pain and tightness in her chest and the hacky cough. She wanted to make sure it was not going into like a viral pneumonia or another thing. She did not know. She kept increasing her Advair use and was at the top of that. She was doing the duoneb which she did not usually have to do. She had not had to do that since Jan2020 when she had the 5-week flu, or it could have been COVID (they were calling it a hoax back then). She was using her duoneb 4 times a day and now she was using it to 2-3 times, but she was still getting chest tightness, hacky cough. It was kind of like nausea- it was hard to explain, it was kind of like a chest nausea, which she had also had back in Jan2020 when she had the bad flu. She also would get this laryngitis and had trouble talking. With her flare-up, her chest tightness/nausea feeling in the chest continued. Now, she was getting into laryngitis type of thing, but she could loosen that up with her duoneb but if she got to the point where she could not do that, she would definitely have to see someone right away. She clarified that when her chest got tight, the dry, hacky cough continued/increased. When she did the breathing treatment, it loosened it up for about 3-4 hours and some of the pain would go away in her chest. If she talked too much, she would begin to cough. She had had this flare up 3 times in her life, it was not very common. She was diagnosed with asthma in her 40s, and this was her 3rd time ever having anything like this. This was the first time she had experienced a flare up like this. She had had 3 episodes since she had had asthma in her 40's and all 3 bad episodes were about the same. All the episodes were related to illness, it did not just happen out of the blue. It happened with a viral respiratory thing or the flu. The adverse events did not require a visit to the emergency room or physician office. The patient stated that she would call her physician or the clinic "today or tomorrow". She had not been to a doctor since her asthma flared up. Her respiratory doctor/pulmonologist moved away, there was no respiratory doctor nearby right now. So, her general practitioner was following her because it was a mild case and she had mild asthma. If it was severe, her doctor would make her go to a specialist. Relevant tests were reported as no. The patient used to be followed with pulmonary function tests until her respiratory doctor moved away. The patient stated that she took care of her 94 year old mother several days a week and because of all of the variances coming out, she thought it was her civic duty to prevent it from spreading through the population and creating more variances which was why she received the vaccine. She stated her doses were scheduled a month apart because they expecting to get a shipment of Moderna and they did not. They had to run to Buffalo to get the Pfizer vaccine, but they left her doses scheduled a month apart because the appointments were so hard to get. Normally, it would be 3 weeks. Her card clearly said Pfizer and they told her Pfizer, and they told her the reason for it being scheduled at 4 weeks. The patient called to inquire whether asthma flare-ups had been seen in clinical trials. It was not a reported side effect from the paperwork she received. When she looked online, she could not really find anything. She was thinking of going to a clinic but was wondering if there were any reports of flare-ups with asthma with the vaccine. With regards to causality, the patient stated it was a concern because she usually did not get a flare-up unless she was sick. She stated that there were many variables, and that it was spring, and bugs were out, but she did not usually get a flare-up like this. She stated that maybe it was a challenge to her immune system, the antibodies, but she did not know. She suspected the flare-up was related to the vaccine, but she did not have any idea. She would say yes, but she had no way of knowing. The flare-up usually only appeared if she got ill or something weird happened to her. The clinical outcomes of the events flu-like symptoms, fever, achy and fatigue were recovered/resolved on 27Mar2021; sore arm and headache were recovered/resolved on 28Mar2021; asthma flare up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were not recovered/not resolved; she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia were unknown. The reporter believed there was a reasonable possibility that the events sore arm, flu-like symptoms, asthma flare-up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were related to BNT162B2. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information the events asthma flare-ups and viral pneumonia are attributed to intercurrent medical conditions, unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-01-01 feeling hot, numbness Metallic taste in mouth as it was being administered. I told them I could taste it. Eyes started h... Read more
Metallic taste in mouth as it was being administered. I told them I could taste it. Eyes started hurting with burning sensation, pressure in both ears and slight numbness across face from ear to ear and under nose. Uncomfortable tightness in chest and a lot of pressure on face feeling like it was hot. I felt a little better after 15 minutes while waiting but never told anyone about symptoms. I walked out and drove home but monitored my symptoms. The symptoms gradually became less and were gone after 1 hour and 45 minutes. I took a dose of benadryl at that time. I slept well that night and woke up with no symptoms and none since.
69 2021-01-03 pain in extremity On 12-21-2020, after the injection patient states she did not feet well and her right index finger b... Read more
On 12-21-2020, after the injection patient states she did not feet well and her right index finger began to hurt right after. She states the right index finger pain started to hurt also on 12-23-2020. She states she will be receiving her second dose on Thursday 01-07-2021.
69 2021-01-04 numbness Numbness from Neck to face to head on the left side. Lasted a few days. 12-30-2020 to January 3rd, ... Read more
Numbness from Neck to face to head on the left side. Lasted a few days. 12-30-2020 to January 3rd, 2021.
69 2021-01-05 pain in extremity Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the... Read more
Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the next morning (12-31-20)with severe chills, headache and dizziness. Felt as if I had covid all over again (was diagnosed with covid on October 12, 2020). My whole body ached and I was extremely fatigued. All I wanted to do was sleep and I also started a slight cough. Later on in the afternoon I started to sweat profusely. I had chills/sweats all through the afternoon and into the evening. I did not even get out out bed until the next afternoon (1-1-21). For 2 days afterwards I had chills/sweats and on 1-2-21 I had terrible stomach cramps and diarrhea.
69 2021-01-06 numbness Vaccine recipient complained of "some left-sided numbness in her ears and arms" almost immediately. ... Read more
Vaccine recipient complained of "some left-sided numbness in her ears and arms" almost immediately. Report received second-hand from the vaccine clinic director.
69 2021-01-11 weakness Light headed; weakness; body aches; This is a spontaneous report from a contactable consumer (patien... Read more
Light headed; weakness; body aches; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 10:00 at single dose in her left arm for covid-19 immunization. The patient medical history was not reported. The patient concomitant that the patient received within 2 weeks of vaccination included "blood pressure" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced light headed, weakness, body aches on 05Jan2021 10:00. No treatment received for the adverse event. The outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
69 2021-01-13 pain in extremity Sore arm; increase in temperature; This is a spontaneous report from a non-contactable other healthc... Read more
Sore arm; increase in temperature; This is a spontaneous report from a non-contactable other healthcare professional (reported for herself). This 69- year-old female patient (reported for herself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EK423), via an unspecified route of administration, on 05Jan2021 at 10:30 AM (at the age of 69-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. The patient does not have any medical history. The patient was not taking any concomitant medications. The patient did not receive any medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jan2021 at 04:00 AM, she experienced a sore arm and an increase in temperature. The patient did not receive treatment for the events. The clinical outcome of the events sore arm and an increase in temperature was recovered. Patient was not tested for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.
69 2021-01-14 pain in extremity experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pa... Read more
experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pains/aches and pains around her body; severe pain in injection arm; injection site very painful; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She reported that the evening of her first dose, she experienced severe pain in injection arm on 06Jan2021. She stated that night injection site very painful. She had to take Tylenol Extra Strength overnight. She stated that she woke up and she was fine. On 09Jan2021, she reported feeling fatigued, dry cough, extreme fatigue, diarrhea, aches/pains, and aches and pains around her body, but no fever. She woke up this morning on 11Jan2021, experiencing pain in her back where kidneys, still fatigued but no fever. She has taken the Covid test and does not have the results. She wanted to know if these are side effects of the vaccine or is this potentially the Covid virus. The events were assessed non-serious. The outcome of severe pain in injection arm, injection site very painful was recovered, of fatigued was not recovered, of other events were unknown. Information on the lot/batch number has been requested.
69 2021-01-15 tingling Patient had vaccination at approximately 12: 30 pm and remained for an initial observation of 20 min... Read more
Patient had vaccination at approximately 12: 30 pm and remained for an initial observation of 20 minutes. The patient returned to the observation area after 1:30 pm complaining of symptom onset at approximately 1:35 pm of "wooziness", faster heart beat, and legs tingling. She did not want medical help but stayed for an hour of observation in which her blood pressure was taken at least twice in the normal range, sat with her legs elevated for a few minutes but not most of that time. At 2:30pm she reported not feeling any better but now reported tingling in hand and leg of her right side only. BP/hr at 2:35pm were 121/96 and 112 from a seated position and both legs on floor. The patient said she would touch base with her physician who is unnamed. She was also given information and encouraged to fill a report herself with VAERS.
69 2021-01-16 numbness Facial numbing within 10 minutes; subsided and gone within 40 minutes. Had read that bell's palsy ... Read more
Facial numbing within 10 minutes; subsided and gone within 40 minutes. Had read that bell's palsy was possible side effect so was not worried.
69 2021-01-16 pain in extremity First day : Pain the arm and chills 2nd day : Nausea
69 2021-01-17 seizure I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sic... Read more
I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included R.A.D., osteopenia, migraine with aura, the patient had previously suffered episodes of vasal vagal syncopy when she got the flu or other severe illnesses, and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included atenolol, atorvastatin, azelastine, and fluticasone. The patient previously took gramicidin, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced allergies. The morning after receiving the vaccine, she felt quite sick, like she had the flu. When she got up from bed and went to the bathroom to urinate, she became very lightheaded and dizzy. She attempted to return to bed, but passed out on the bedroom floor before she could get to the bed, and seized while she was unconscious. Once she came to, she was helped to bed and, after about 90 minutes, felt much better, and got up, and ate food and had coffee. All events occurred at 07:30 AM on 09Jan2021. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021. Information on the lot/batch number has been requested.
69 2021-01-18 tenderness Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, p... Read more
Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, painful making legs feel like 2 cement blocks to walk. Both shoulders were inflamed and muscles locked causing difficulty in mobility. Both hip joints felt irritated, the left more aggravated and painful. Also the body experienced being tired and sluggishness needing more than usual sleep. This lasting about 8 days. Treatment: ActivIce/Biofreeze spray several times daily and elevation to release pressure and blood flow.
69 2021-01-19 pain in extremity At 1332, she called into the office to let us know that she was not feeling well after her vaccine. ... Read more
At 1332, she called into the office to let us know that she was not feeling well after her vaccine. 1331 2 RN's got to her vehicle to assess her. She stated she was feeling "not right", complained of her left arm hurting, a headache, and right ear pressure. Vital signs at 1339 showed a BP of 138/76 done by manual cuff, a pulse was taken radially and was 78 bpm, with a regular rate and rhythm by palpation, respirations were 26 breaths per minute, and her O2 saturation was 99%. 1342 she had episodes of emesis out the side of her vehicle multiple times. 1344 EMS was called. 1347 50mg of IM Benadryl was administered into her right deltoid. EMS arrived at 1349 and care was transferred over at that time. Her husband took her car keys and was driving separate to Emergency Department.
69 2021-01-19 burning sensation Noticed small area of burning sensation at right side of wrist and the vein there was very enlarged ... Read more
Noticed small area of burning sensation at right side of wrist and the vein there was very enlarged and sticking out.
69 2021-01-19 weakness Patient advises that she had developed injection site soreness on the night of her injection. The ne... Read more
Patient advises that she had developed injection site soreness on the night of her injection. The next day, she started with symptoms of generally feeling unwell and headache. She also reports that several days after the vaccine, she had some shortness of breath, dizziness, and weakness but did not seek medical care. Patient states she had fatigue, muscle pain, chills, sweating, and runny nose on 1/15/2021. On 1/18/2021, patient complains of headache. COVID test was ordered and patient was advised to go to Urgent Care for exam if she felt she needed to see a doctor. COVID test resulted negative.
69 2021-01-19 difficulty speaking Patient describes Soreness at injection site, later experienced body aches, headache, fever that is ... Read more
Patient describes Soreness at injection site, later experienced body aches, headache, fever that is rising and hoarseness in voice
69 2021-01-20 pain in extremity Injection into left arm hurt upon injection; The arm got very sore and felt like lead-I could barely... Read more
Injection into left arm hurt upon injection; The arm got very sore and felt like lead-I could barely raise my arm up without assistance of the other arm; The arm got very sore and felt like lead-I could barely raise my arm up without assistance of the other arm; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the left arm on 07Jan2021 at 14:00 at a single dose for COVID-19 immunisation. Medical history included HBP (hypertension). The patient was not pregnant at the time of vaccination, has not received any other vaccine within four weeks, and did not have COVID prior to the vaccination. Concomitant medication included losartan (also reported as other medication in two weeks). The patient previously took Aleve and experienced allergies. On 07Jan2021 at 02:00 PM, the patient experienced injection into left arm hurt upon injection and as the hours wore on, the arm got very sore and felt like lead-she could barely raise her arm up without assistance of the other arm. However, it dissipated within 24 hours and felt fine thereafter. The patient did not test positive for COVID post-vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
69 2021-01-20 pain in extremity Severe 9/10 Right and left Achilles and low foot pain and pain on palpating-left greater than righ... Read more
Severe 9/10 Right and left Achilles and low foot pain and pain on palpating-left greater than right-not relieved with Ibuprofen. This interferes with walking due to pain.Never had pain in that location before
69 2021-01-20 pain in extremity anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; musc... Read more
anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; muscle aches; Loss of taste; Loss of smell; Nausea; sore arm; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EJ1686, intramuscular in right deltoid on 03Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing essential tremor started in her 50's. The patient's concomitant medications were not reported. The patient did not receive other vaccine within four weeks. On 03Jan2021 the patient experienced sore arm and tiredness. On 07Jan2021 the patient experienced anterior cervical fusion and was hospitalized from 07Jan2021 to 09Jan2021. On 08Jan2021 the patient experienced nausea. On 09Jan2021 the patient experienced muscle aches, loss of taste and loss of smell. On unknown date the patient experienced headache. The patient was tested positive to COVID-19 on 11Jan2021. The patient did not visit Physician Office or Emergency Room. Laboratory data included COVID-19 Rapid Test positive on 11Jan2021. The outcome of the events tested positive for COVID-19, and anterior cervical fusion was unknown. The outcome of the events sore arm, tiredness, nausea, muscle aches, headache was resolving. The outcome of the events loss of taste, loss of smell was not resolved.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and COVID-19 test positive on 11Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. This 69-year-old female had medical history of ongoing essential tremor started in her 50's. The reported anterior cervical fusion was most likely due to concurrent disease, and unlikely causally related to the vaccine of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-01-21 feeling hot Patient at 1440 patient wasn't feeling right. feeling hot and shaky. BP 149/72. 96% spo2. HR 63 oth... Read more
Patient at 1440 patient wasn't feeling right. feeling hot and shaky. BP 149/72. 96% spo2. HR 63 other medical conditions was reported as no. but blood sugar was 63. Patient given grape juice and sandwich repeat bs was 102 patient recovered with no further treatment.
69 2021-01-22 weakness Extreme fatigue, headache, dizzy, backache, cold sore. General weakness especially in lower extrem... Read more
Extreme fatigue, headache, dizzy, backache, cold sore. General weakness especially in lower extremities - started 7-10 days after injection.
69 2021-01-23 weakness I became weak and thought I was going to faint. I called the medical professional over and they brou... Read more
I became weak and thought I was going to faint. I called the medical professional over and they brought me into a staged area for triage. My blood pressure was 171/ 104 or 114. I had chest pain. The EMT did and EKG, listened to my heart, and started an IV. The ambulance was called and I was transported by ambulance to the hospital. At the hospital another EKG was taken, blood pressure and blood work. Repeated blood work was taken. I was admitted to the hospital due to elevation of tyoponin level and chest pain. The following day 1/22/21 I saw my PCP and he thought it was related to the vaccine and recommended a cardiologist for the increased levels of tyoponin and chest pain. The cardiologist performed another EKG< more blood work and performed a cardiac catheterization and a ECO. Both were normal. Prior to that I was given a nitro pill as my chest pain was between a 7 and a 8; a few minutes later the nurse asked about my pain level and it was a 3-4. I was given another nitro pill and shortly after I felt extremely faint and my blood pressure was 56/32. I was immediately given a bolus of saline IV . The chest pain continued through the day. The following day, I had no further chest pain, my tyoponin levels returned to normal and I was released from the hospital.
69 2021-01-24 tremor Rapid heart beat in chest, neck and head, Elevated blood pressure Pounding head ache Chills with unc... Read more
Rapid heart beat in chest, neck and head, Elevated blood pressure Pounding head ache Chills with uncontrollable shaking
69 2021-01-25 weakness, night sweats 2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vom... Read more
2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vomiting 3:00-extreme headache (took aspirin for pain) -lower back hurt -pain in right shoulder, elbow, wrist -couldn?t lay on right side (bruising at site but no swell -couldn?t move without vomiting -woke up at midnight completely wet with sweat and sweating continuing even today Tuesday -weakness all over (felt like I had had the FLU) ? I knew there was potential for side effects before taking the vaccine...I was totally unprepared for so many symptoms and how intense they were and what little I could do to relieve any of them. Never had fever that I am aware of. Today I?m weak and sweating is unreal. ?? Should I prepare/expect my second dose around Feb. 14 to have the same effect on me.? Not looking forward to that. I was almost ready to go to the ER I was getting so dehydrated and weak.
69 2021-01-25 breast pain, pain in extremity Two days (Friday) after the injection (Wednesday) a pain arose in my shoulder muscle on my left side... Read more
Two days (Friday) after the injection (Wednesday) a pain arose in my shoulder muscle on my left side just behind the injection site. By Sunday afternoon the pain became debilitating and the pain spread to my underarm and the edge of the breast area. I applied heat and rested. The sharp pain interfered with sleep and regular life activities. On Tuesday morning I applied an ice pack, which relieved the pain. After applying ice for two more times, the pain subsided and the swelling under my arm disappeared. I was able to resume normal activities with slight discomfort.
69 2021-01-25 night sweats sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme f... Read more
sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme fatigue, swollen lymph nodes, increased blood pressure, night sweats
69 2021-01-26 night sweats Extreme night sweats to the point of wrenching bidding. Would occur they the nite waking me. Never h... Read more
Extreme night sweats to the point of wrenching bidding. Would occur they the nite waking me. Never had this before.
69 2021-01-26 pain in extremity Severe pain in right arm. Very little range of motion. Shoulder joint very painful.
69 2021-01-26 pain in extremity She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was s... Read more
She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was sent to ER for evaluation of leg weakness.
69 2021-01-26 pain in extremity first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headac... Read more
first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headache, felt under the weather. Third day more swelling, redness and headache. Today, forth day, swelling going down still red, no headache and feeling better in general. Took tylenol for headache and pain.
69 2021-01-27 pain in extremity 1st shot...none 2nd shot: 1st night-fever, headache, chills major all over stiffness ... Read more
1st shot...none 2nd shot: 1st night-fever, headache, chills major all over stiffness 2nd night- fever over 100 degrees, major chills and shivering, joint stiffness, no headache 3rd night- no fever but MAJOR sweating, sweating, sweating. No headache, stiffness much improved. 4th day - all symptoms almost gone, no headache, stiffness improved. Arm still sore
69 2021-01-27 pain in extremity Mild arm soreness.
69 2021-01-27 numbness blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizzin... Read more
blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizziness; extreme debilitating aches and pains; body felt numb; fever; chills; This is a spontaneous report received from a contactable nurse (who is also the patient). A 69-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: RH9899, expiry date: unknown), intramuscular in left arm, on 21Dec2020 09:30, at single dose, for COVID-19 immunization. Medical history included allergies to shellfish and bee stings. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and is not pregnant. On 23Dec2020 at 20:00, the patient experienced headache, blurred vision that lasted nearly two weeks, extreme debilitating aches and pains, body felt numb, bedridden due dizziness, fever and chills. Treatment for the events included ibuprofen (ADVIL). The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. The reporter assessed this case as non-serious.
69 2021-01-28 pain in extremity When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started i... Read more
When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started irritating a little bit. So then i left it alone because I didn't now if that was part of a reaction. When i got home i still had the odor in my mouth. i drank cold water and it went away. I waited. I felt sore on my arm but it wasn't that bad but as the hours went on it started getting more sore and painful. My arm was sore up to my shoulder and the back. After that the pain started traveling towards to my chest and i started getting pain in my chest. i took Tylenol (1 500 mg extra strength at 11:15 PM). So i waited 15 minutes to go to sleep. i got up the next day and everything was the same, i started putting ice on it and gave it time. I took another Tylenol but the pain was in my chest again a little bit. The third day the pain didn't come back in my chest and from then i was alright. I also started getting an itch.
69 2021-01-28 involuntary muscle movements, weakness temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off;... Read more
temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off; first it was up around 163/71 and then over time it was really low 118/58; HR was high; body was jerking; arm that she got the injection in was dropping; dehydrated; urine is darker; real thirsty; extremely weak; tired and exhausted; feeling horrible; couldn't stay awake, fell asleep; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included left hip replaced on 16Nov2020 and had her right hip replaced on 29Dec2020. There were no concomitant medications. Patient reported that she got the shot at 1:30 pm and on the way home she started getting tired and exhausted on 14Jan2021. She got home and went right to bed. She felt like she couldn't stay awake, fell asleep and woke up about 6 pm then with a temperature of 105.5 and stated it would fluctuate between 104-105. She was just feeling horrible. At 7:30 pm, patient had a temperature of 103.5 and at 7:45 pm, her temperature was 104. On 14Jan2021, patient stated that she couldn't see straight, had blurred vision, having trouble walking, her balance was off and falling into walls. Her body was jerking and the arm that she got the injection in was dropping. Patient called her cardiology office, and was advised to take Tylenol 3-4 times per day and alternate it with Motrin. She was also taking coated 325 mg aspirin. She can hold her head up and was not jerking as much as she was. She was doing noticeably better. Patient had put ice bags on her groin, stomach and throat to try to cool down through the night. This brought temperature down to 103. She woke up at 12 am she was 102. Her temperature at the time of report was around 101-102. She took her blood pressure it was going crazy, first it was up around 163/71 and then over time it was really low 118/58 and heart rate was 130 for a while and went to 103. The back of her neck still felt so weak and she still feels extremely weak and exhausted. She went on to report that her HR was high and B/P was up but since then it has come down. The night of 14Jan2021, her b/p was low.On 14Jan2021, patient was also real thirsty and her urine was darker and was probably dehydrated and thought that she was real jerky muscle-wise, like she is not in control of anything last night. That she has not taken BP or heart rate on 15Jan2021, but it was not pounding today though. She was doing better today at the time of report. Patient was recovering from the events of fever, blurred vision, and balance was off; not recovered from tired, jerking, and dehydration. Outcome of remaining events was unknown.
69 2021-01-29 discomfort 2 days after injection, I broke out in Shingles (confirmed by the Dr. on my scalp, left side of fore... Read more
2 days after injection, I broke out in Shingles (confirmed by the Dr. on my scalp, left side of forehead and radiating toward my left eye. MD stated it was too coincidental not to be related to vaccine. I had NO s/s of illness prior to injection. MD would not allow me to take 2nd dose.
69 2021-01-29 pain in extremity, tingling Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away withi... Read more
Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away within 30 minutes. But 2-3 hours later three fingers had peeling. Also wrinkly fingers. Increased water and added electrolytes. Notified doctor, who instructed to elevate and ice arm, and to start benadryl. Also take benadryl before next vaccine. Left arm may still be slightly swollen, but most swelling gone by 12 hours. Sore arm for a couple days, intermittent headache which took tylenol for. Fatigue, still.
69 2021-01-29 pain in extremity sore arm, headache that night, nausea the following day.
69 2021-01-30 weakness Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin,... Read more
Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin, Zofran, chicken broth for electolytes> Signs included hypotension, nausea, headache, weakness, I am a retired doctor married to an Endocrinologist and living to take care of my 2yo grandson for my daughter who is a resident in PEDS , I and my family are very familiar with managing my illness, which infrequently presents with crisis and I very rarely must be hospitalized .
69 2021-01-30 feeling cold Had chills all night - from ~ 5pm until 5am on the 30th. @ 5 am om the 30th - I had intermittent p... Read more
Had chills all night - from ~ 5pm until 5am on the 30th. @ 5 am om the 30th - I had intermittent periods of chills - but much less severe. Also had a temp of 100,2 w/ slight headache. Started taking tylenol about 3 am on the 30th.; then every 6 hours after. Did stay in bed - slept basically until 9am - this date 1/31/21. Although I think this was a "normal" reaction - just thought I should report it - to add to generally data about the vaccine.
69 2021-01-31 pain in extremity Got the flu like body aches; Got 100 temperature; Had a sore arm but it was mild; Started hurting a ... Read more
Got the flu like body aches; Got 100 temperature; Had a sore arm but it was mild; Started hurting a little bit more; This is a spontaneous report from a contactable nurse, the patient. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248; Expiration Date: Apr2021), intramuscular in the right upper arm on 15Jan2021 at 12:30 (at the age of 69-years-old) as a 0.3 ml single dose for COVID-19 immunization. Medical history included atrial septal defect, palpitations, and COVID-19 from Aug2020 to an unknown date. The patient had COVID antibody titers done in Aug2020 and Dec2020 and they were "270." Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), cyanocobalamin (B12-VITAMIIN), estrogens conjugated (PREMARIN), pravastatin (MANUFACTURER UNKNOWN), and escitalopram oxalate (LEXAPRO). On 15Jan2021 after getting the vaccine, the patient had a sore arm but it was mild. Then as the night went on, it started to hurt a little bit more. On 16Jan2021, the patient had flu like body aches, and had a temperature of 100. The patient did not receive any treatment for the events. The clinical outcome of the sore arm that hurt a little bit more was not recovered; while that of the flu like body aches and a temperature of 100, were unknown. The nurse thought the events were related to the vaccination.
69 2021-02-01 pain in extremity I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot ... Read more
I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot that high up. She said in a snide voice it?s still the deltoid and she shot my bursa. The evening of the shot I started having severe arm pain and nausea. The next morning I had right scapula rib pain it was hard to breathe my arm hurt very bad I can hardly lift it I went to work. When I got to work I couldn?t function I was so nauseated with the pain I went home that day and I?ve missed three days total from that event of wrong injection site. The pain has gotten worse I can?t lift my arm left right upper down without pain and it?s going into my neck and down to my elbow now I went to the occupational medical doctor. I told him what happened and he said she gave me the shot am I supraspinatus Bursa and I have an injury to my bursa. I came back for a second visit the next week and he said I have bursitis from that now I can?t raise and use my arm that well at all and I have severe pain 24 seven still and he sent me to a physical therapist starting today 2 to 21. It has gotten worse and my shoulder has locked up three times. I still have ongoing pain 24 seven and I want to report a complaint against the girl who gave my shot I thought she was an LPN but she is a MA. We both work at healthcare clinic. I am a 26 year RN and she did not listen to me and she stuck me anyway against my will.
69 2021-02-03 flushing, feeling hot Dizziness c/o feeling warm and flushed. Felt dizzy while getting into recliner. monitor 15 min. Reso... Read more
Dizziness c/o feeling warm and flushed. Felt dizzy while getting into recliner. monitor 15 min. Resolved. Narrative: 2nd dose given. C/o feeling warm and flushed. 183/73, 63, O2sat 100%. Felt "dizzy" when transferring to the recliner. no loc. VS monitored: 159/71, 60; After 15 min: 138/64, 60 and asymptomatic and no c/o
69 2021-02-03 pain in extremity Fast heartbeat, dizziness, sore arm, trouble lifting and pain, still have problem 2 weeks later
69 2021-02-03 difficulty speaking The patient was referred by her primary care provider's office to receive COVID-19 vaccination. She ... Read more
The patient was referred by her primary care provider's office to receive COVID-19 vaccination. She received her first dose of Pfizer-BioNTech COVID-19 vaccine at approximately 15:07 hrs. Due to her history of allergic reactions to multiple medications (including sulfa antibiotics and ceftriaxone), she was advised to extend her monitoring period to at least 30 minutes post-injection. At around 15:50 hrs I was notified that the patient was feeling a tingling sensation in her throat, itching, and a change in her voice. She was transferred to a stretcher for acute management of suspected anaphylaxis. Airway, breathing, circulation, and mentation were assessed immediately. EMS was called immediately via 911. Her vital signs were obtained, with a BP 168/90 mm/Hg, HR 105/min, RR 24/min. She reported shortness of breath at the time. There was no stridor or wheezing on exam. She appeared in mild respiratory distress. At 15:54 hrs she was given an intramuscular EpiPen injection (0.3 mg autoinjector) in her left thigh. At 15:58 she was given an intramuscular methylprednisolone injection (125 mg) in her right thigh. Immediately after that EMS team arrived and took over her care with plans to administer diphenhydramine intramuscularly, and will transfer to ED for further management. Throughout the event the patient remained awake, alert, and fully oriented.
69 2021-02-03 cold sweat Within 15-minutes of vaccination, the patient became nauseous, clammy, dizzy, and had a near syncopa... Read more
Within 15-minutes of vaccination, the patient became nauseous, clammy, dizzy, and had a near syncopal episode. EMS reported the patient's blood pressure being 70/40 mmHg. EMS administered IV saline and transported patient to emergency department. In the emergency department, patient stabilized and was discharged shortly after.
69 2021-02-04 tingling I had the sensations of facial tingling; eye swelling; lip swelling; This is a spontaneous report fr... Read more
I had the sensations of facial tingling; eye swelling; lip swelling; This is a spontaneous report from a contactable Nurse. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration on the right arm on 20Jan2021 08:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Sulfa and allergy to animal (cats) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 20Jan2021 08:45 AM, the patient stated, "I had no symptoms during the 15 minute observation after the vaccine. After leaving the site, about 30 minutes after the shot I had the sensations of facial tingling, eye swelling and lip swelling (nothing visible on a photograph). My pulse remained stable and I had no throat symptoms or trouble breathing. This all resolved spontaneously within an hour after the shot. I am allergic to cats and sulfa but have never had anaphylaxis. I plan to stay in observation for a little longer after the 2nd shot. Any other recommendations?" No treatment was received for the events. The outcome of the events was recovered on 20Jan2021.
69 2021-02-04 numbness Within 5 minutes there was extreme anxiety followed by swelling of finger, face and feet, , loss of ... Read more
Within 5 minutes there was extreme anxiety followed by swelling of finger, face and feet, , loss of voice, swelling of throat, Treated with Benadryl, oral steroids, with some improvement over 30 minutes Then worsened with increased throat swelling, numbness of feet. Taken to ER above, treated with Epi injection, Iv solumedrol and pepcid with improvement Sent home after 3-4 hours, Next morning 12 hours after leaving Er Voice better but began to worsen another dose of oral prednisone, benedryl andPepcid taken with improvement
69 2021-02-04 feeling cold slight headache, slight, nausea, chilling
69 2021-02-05 flushing I received my first COVID19 at around 5:00 p.m. at Walgreens. I was asked to remain in the store f... Read more
I received my first COVID19 at around 5:00 p.m. at Walgreens. I was asked to remain in the store for 15 minutes. By the time I got home, at around 5:25 p.m., I was feeling woozy, my neck was red (flushed), I had a strange metallic taste in my mouth, I was very thirsty, and I felt that my throat was somewhat constricted. I immediately took a Benadryl. (I knew to do this because I had done this when I had an allergic reaction to penicillin years ago. By about an hour later I felt alright and the redness on my neck had almost faded away.
69 2021-02-05 flushing after 30 mins, pt reports feeling "flushed"
69 2021-02-06 migraine, pain in extremity Severe migraine headache on morning following vaccine, affecting vision for about 30 minutes, took 2... Read more
Severe migraine headache on morning following vaccine, affecting vision for about 30 minutes, took 2 Tylenol 500mg each, had bad headache for rest of the day. Left arm pain that radiated into left shoulder and neck area, applied heat. Was awakened very early 2nd morning with headache, causing me to get up as hurt to lay head on pillow. Took 2 Tylenol, so far only slight decrease in pain.
69 2021-02-06 pain in extremity Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to... Read more
Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to my shoulder. By the next day, it was really painful in my shoulder and across my back almost to my backbone. It was painful to move my arm up or down or to reach for things. This lasted 3 to 4 days. Then my neck on the same side as the shot (left) began to hurt so badly I couldn't move my neck up or down or sideways. It was strange the way the pain slowly moved across by arm to my shoulder to my back and up my neck. I've never experienced anything like this before. Today my pain in my neck is bearable but I have soreness and a headache. I hope I am at the end of the cycle to this event as I am scheduled for my next shot soon.
69 2021-02-09 pain in extremity Pain through back across both arms and neck.; A headache that feels like my heads going to explode.;... Read more
Pain through back across both arms and neck.; A headache that feels like my heads going to explode.; swell up like a balloon; Nauseated; Chills; fever; Pain on both my legs cannot walk; Pain through back across both arms and neck. Cannot lift my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the right arm on 20Jan2021 16:00 at single dose for covid-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing , hypersensitivity (Known allergies: Yes) from an unknown date and unknown if ongoing, covid-19 (if covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Concomitant medications included unspecified medications. The patient experienced pain through back across both arms and neck, the patient cannot lift their arms. The patient also experienced pain on both their legs cannot walk, a headache that feels like their heads going to explode, nauseated all the time, swell up like a balloon, chills and fever. It was reported that the events occurred on 21Jan2021. Therapeutic measures were taken as a result of pain through back across both arms and neck. The patient did not recover from the events. Information on the lot/batch number has been requested.
69 2021-02-09 migraine Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (... Read more
Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 14:30 at a single dose, for COVID-19 immunization. Relevant medical history included allergies to sulfa drugs. Concomitant medications included escitalopram, alprazolam, paracetamol (TYLENOL), simethicone (GAS X), and vitamin D. The patient previously took aspirin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Facility. On 12Jan2021, at 14:30, the patient experienced soreness at shot site, fatigue, and migraine. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination. Information on the lot/batch number has been requested.
69 2021-02-10 feeling cold Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; co... Read more
Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.
69 2021-02-10 weakness deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache... Read more
deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache; body aches; fatigue; dizziness; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; will fall asleep through the day for 3-4 hours at a time and she does not even nap usually; Muscle pain; Neck ache; Backache; Problems with walking; problems with balance; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3246), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a single dose for covid-19 immunization. Vaccine was not administered in a military facility. Medical history included ongoing ulcerative colitis, ongoing high cholesterol, ongoing high blood pressure, celiac disease from 2005 (this has been tested too many times to count and it has been negative since after initial diagnosis 2005), arthritis (all her life) ongoing, hip replacement surgeries first done in 2005; repair of same hip in 2015; other hip in 2017. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines include Pneumonia Vaccine, Shingles Vaccine and Flu vaccines; all on an unspecified date for immunization. She never had adverse events with those. Ongoing concomitant medications included rosuvastatin (5 mg tablet) for high cholesterol, mesalamine (400 mg capsule) for ulcerative colitis and lisinopril from 2018 for high blood pressure. According to the patient, she knows that mesalamine is an immunosuppressant and anti-inflammatory to keep inflammation in the colon down. This consumer was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021 14:30 with immunosuppressant mesalamine. The night of 14Jan2021 patient had headache, chills, body aches, diarrhea, fatigue, fever and dizziness like Covid 19 symptoms. She went to the ER during the past 11 days for IV fluids due to deyhydration from the diarrhea. Today, 25Jan2021 is the first day she has been out of the house, except to go to the ER, since she received her 1st vaccine dose. On Jan2021 muscle pain, neck ache, backache, problems with balance and problems with walking. Events probably started with intense diarrhea starting 14Jan2021; then Fever over 102 degrees Fahrenheit and chills 14Jan2021; Specific onset dates and onset times unknown otherwise other than between 14Jan2021 and 16Jan2021 onset dates. It was a rolling week of agony after that with one adverse event after another until she ended up in the emergency room on 16Jan2021 because she was so dehydrated and was really sick. She was not admitted to the hospital related to any of these events; but while in the emergency room she was given intravenous fluids; a chest x-ray; blood work; after maybe 5-6 hours she was sent home; she was also given a COVID test which was negative; and then 2 days later took another COVID test which was also negative. Both COVID tests were Rapid Tests: on 16Jan2021 and 18Jan2021. On the Chest xray they suggested she had some sinus tachycardia which is just a rapid heartbeat and not surprising; nothing else showed up on Chest x-ray; as far as anything else testing/results wise there was only some facetious blood work which they just said to follow-up with her PCP regarding but nothing really out of the ordinary. She can finally out of bed on a regular basis for a couple of hours daily; she is still very fatigued; she has no muscle pain, neck aches or body aches at this time; she does not have the strength she should have; is no longer experiencing headaches or fever; but is extremely tired. She will fall asleep through the day for 3-4 hours at a time and she does not even nap usually (Jan2021). She has not driven yet but assumes probably once she is a little stronger she will be able to drive again. She did not have upper respiratory, chest or cough issues. The outcome of the events fever, headache, body ache, muscle pain, neck ache was recovered on Jan2021; fatigue was not recovered. The outcome for the other events was unknown.
69 2021-02-11 cold sweat Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over he... Read more
Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over her chest, light headed, patient said she feels like she was going to pass out immediately after vaccine administration. VS 100/60 mmHg, pulse 64, RR 22. Patient complaints of headache, nausea and skin clamy and warm. Site manager made aware, o2 @ 2 L via nasal cannula administered. EMS transport to hospital. Daughter was made aware via VM, unable to reach 3x attempts.
69 2021-02-16 weakness, nerve pain Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funn... Read more
Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funny; Head spinning; Weakness; nerve pain; stomach nausea; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration, in the right arm, on 16Jan2021 14:15 at a single dose for covid-19 immunization. Medical history included left-sided breast cancer from 2005 and lymph nodes removed on her left side. Concomitant medications included pravastatin and a lot of vitamins. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccine administered on same date of the Pfizer suspect. It was reported that the patient took first shot and got anxious on 16Jan2021. The patient also experienced a lot of fatigue on 16Jan2021, went home and got worse then was hospitalized. The patient had a virtual visit with her doctor and wanted some advice, and her doctor didn't give her any prescriptions. The patient also felt something in her chest area on 16Jan2021, after receiving the COVID-19 vaccine. Events anxious and fatigue required emergency room visit. The patient was hospitalized from 25Jan2021 to 27Jan2021 for the events anxious and fatigue. The patient also experienced head spinning, chest feeling funny, weakness and stomach nausea on unspecified date in Jan2021. Reported she was given all kinds of medicine in the hospital. She said as long as she was laying down, she was good. She said once she got up, and moved around, she felt the weakness again. She said she was put on depression medicine (Jan2021) while in the hospital, and was given 4 different prescriptions at discharge. She said the only thing that helps her go to sleep at night is a 1/2 tablet of generic alprazolam for anxiety. She said she knows she can't stay on the generic alprazolam forever, clarifying that is why the doctor put her on the depression medicine. Reported she was given the following medications in the hospital, as well as, prescriptions to continue the medications at home after her hospital discharge: escitalopram 10mg for depression. She said she is to take one escitalopram 10mg every evening for 30 days. She said she was given escitalopram 10mg for the two days she was in the hospital. Generic gabapentin 100mg for nerve pain (Jan2021) and she is to take 1 capsule nightly for 30 days. She said she started the gabapentin 100mg while she was in the hospital. Pantoprazole 40mg, she was given a one-time small IV bag of pantoprazole 40mg for her stomach while she was in the hospital (clarified she was given on 27Jan2021 at 05:26). She said she was having some stomach nausea (Jan2021), and the pantoprazole 40mg was to protect her stomach. She said she told the doctor she didn't want to take the pantoprazole 40mg any longer because she thought she was being given too many different medicines. Reported her fatigue is not the same as it was when she went to the hospital, but the fatigue is still there. Reported her lab work (Jan2021) was good, and her test results were fine when she was in the hospital. She said she was told she was 30% from being on the verge of having heart disease. She said her doctor told her the heart disease was preventable if she eats right, and makes some other changes. She said her cholesterol has gone done. She said she just has the fatigue, and that was why she was put on medicine. Therapeutic measures were taken as a result of the event anxious, fatigue, nerve pain and stomach nausea. Outcome of the event fatigue was recovering while it was unknown for all the other events.
69 2021-02-17 pain in extremity Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache;... Read more
Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9263 and expiry date unknown) on 26Jan2021 18:00 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included Lupus, Lyme disease, hypothyroid, Meniere's, and sulfa allergies. The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included levothyroxine (LEVOTHYROXINE), acyclovir (ACYCLOVIR), ezetimibe (EZETIMIBE), hydroxychloroquine (HYDROXYCHLOROQUINE). No other vaccine received in four weeks. The patient experienced adverse events from 20:00 on 26Jan2021. She experienced sore arm, radiated to shoulder, then to back toward backbone, then up back and side of neck. It's very painful. On 07Feb2021 ("today"), her neck pain was better but she had a headache. These events took place ongoing for several days after and since she had the vaccine. It was reported that the events resulted in Disability or permanent damage. The patient did not receive treatment for the events. The outcome of the events was provided as recovering.
69 2021-02-17 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration at Right Arm on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced right arm pain on 28Jan2021. The date of her second schedule dose on 17Feb2021. The outcome was recovered on 28Jan2021.
69 2021-02-21 pain in extremity A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was... Read more
A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was extremely achy. It was still happening as of Saturday, I also felt lightheaded. I felt like a was on a merry-go-round, it felt like it kept getting faster and faster. I felt dizzy all day Saturday. I had to rest all day. I lost my appetite. Anytime I got up to go to the bathroom, I had to hold something to walk. I also had a mild headache. I felt better on Sunday. My arm was still a little sore as of yesterday but it is better today.
69 2021-02-21 burning sensation After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this ... Read more
After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this past two weeks. I experienced nausea, dizziness, felt like my brain was on fire. Last week I could not comprehend what people were saying, I did not understand. Extreme irritation, anxiety, depression. Fatigue and tiredness, my legs are weak. My blood pressure went skyrocketed: 169/80.
69 2021-02-21 pain in extremity Chills, body aches, fever, sore arm
69 2021-02-21 hot flush I'm 69 and never really had but a few random minor hot flashes when I experienced menopause at age 5... Read more
I'm 69 and never really had but a few random minor hot flashes when I experienced menopause at age 50. However, it isn't on the list of side effects but I've had hot flashes every few hours since about and 2 hours after my first dose injection. For the most part they are mild but come on every 1 to 4 hours while I'm awake. I had a terrible one like I'd never had before where I was soaked through my clothes almost exactly 24 hours after the shot the following day. They are still occurring now 72 hours after the shot. they are mostly bothersome and will hopefully subside in the next few days. Other than that I only had the normal local tenderness on my arm.
69 2021-02-21 unresponsive to stimuli Patient received first dose of Pfizer Covid vaccine at 13:00 at vaccination clinic on 2/21/2021. Pa... Read more
Patient received first dose of Pfizer Covid vaccine at 13:00 at vaccination clinic on 2/21/2021. Patient began to complain about feeling tired and wanted to take a nap later in the afternoon. Patient's husband found patient at 16:30 almost unresponsive and checked a BG reading which resulted at 25. Husband gave patient oral forms of sugar and transported to ER where he BG slowly normalized. Husband reports patient has been a well controlled diabetic and has never has an incident like this happen previously.
69 2021-02-22 pain in extremity Sore arm, slight fever (100.6), fatigue, slight intestinal distress
69 2021-02-23 flushing Client states she experienced flushed face after received her vaccine. Vital signs obtained by EMS ... Read more
Client states she experienced flushed face after received her vaccine. Vital signs obtained by EMS BP 169/98, HR 62, O2 sat 97%. Client states she feels better. Client advised to be transported to the hosp. Client denied. Client discharged home by EMS.
69 2021-02-23 muscle spasms, feeling hot Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontane... Read more
Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), via an unspecified route of administration in right arm, on 26Jan2021 at 13:15 (01:15 PM), at a single dose, for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a doctor's office or urgent care facility. On 26Jan2021 (reported as 12:15 AM; pending clarification), the patient woke up lightheaded or dizzy, with dry heaves, very warm, and with Charley (reported as Charlie) horses in both legs, then she got the chills. This morning (27Jan2021), the patient felt fine. No treatment was administered for the adverse events. The patient was not tested for COVID-19 post vaccination. The patient recovered from the events on 27Jan2021.
69 2021-02-23 tingling Pt in tent f1 at the observation lane felt tingling chest, paramedics assessed pt. Once symptoms s... Read more
Pt in tent f1 at the observation lane felt tingling chest, paramedics assessed pt. Once symptoms subsided paramedics released the pt. to leave.
69 2021-02-23 tenderness She got the vaccine which was fine, at the end of the 20 minute waiting period had a spot the size o... Read more
She got the vaccine which was fine, at the end of the 20 minute waiting period had a spot the size of a dime, really sore and pink. On her way home she started having bowel issues, got home and an hour to hour and half later got explosive diarrhea, which lasted 24 hours. The spot on her arm got larger, more tender and felt warm to touch. It got to be the size of a half softball size, no swelling. Then she started having trouble breathing, could not walk as far or fast without breathing problems. She then took it easy, and the breathing issues got worse for 36 hours. On Sunday her arm was better, less sore and the diarrhea had stopped. She then stopped improving and on Tuesday 2/16/21, she was told to go to the minute clinic on 2/18/21 and when she got there her pulse rate was 40, her oxygen level was 93, and her BP was elevated. The NP there she got her oxygen level up to 94, was real raspy in her lungs. She was sent to the UC and they sent her to the ER. She was seen in the ER and isolated her, did an EKG, had a chest x-ray, gave her breathing treatments, and waited on her results, which all came back fine. They gave her 150 mg of Prednisone, another breathing treatment and within 1 1/2 hours her oxygen level was up to 97 and all of her tests were negative and they sent her home. She has now been home since last Thursday with nebulizer treatments Ipratropium bromide and Albuteral sulfate 3 times a day, rescue inhaler 4 puffs every 6 hours, Advair twice a day as well. She does have a FU with her doctor tomorrow for recheck. She feels that she is almost back to normal.
69 2021-02-23 feeling hot The itching was located just below the injection site at a spot where the skin was a little red; The... Read more
The itching was located just below the injection site at a spot where the skin was a little red; The itching was located just below the injection site at a spot where the skin was a little red; terrible itching in her left arm; out of balance, her balance was messed up; nervous; Sweaty; Feeling hot; felt like her heart was racing fast; felt dizzy/terrible lightheadedness; Feeling anxious; trouble sleeping; sharp pain in her muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health care professional reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot EL9263) via an unspecified route of administration at arm left on 24Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included drug allergies, IV contrast reaction. The concomitant medication was not reported. It was reported patient got the Pfizer COVID 19 vaccine Sunday 24Jan2021 at 13: 00PM in the left arm. She was scheduled for the second dose of the vaccine 16Feb2021. she got the vaccine and was perfectly fine; she started the wait time of 45 minutes and about 10 minutes into it she got really hot and felt like her heart was racing fast; felt dizzy on 24Jan2021. A nurse practitioner and a doctor came over and sat with her; she got some water and she was okay. They thought it was anxiety related to coming into a crowd, but for the next 36 hours she continued to feel anxious and on edge; she felt like she had too much caffeine. That night she had trouble sleeping; she had sharp pain in her muscles on 24Jan2021, it would be in one of her thighs then the other one. This was about 12 hours after the vaccine. States she took some tylenol and it did help. Adds she just continued to feel anxious and she was sweaty. States she has never has anything like this before. Today she felt perfectly fine; all of her symptoms had resolved. Then today, when she was driving to a routine GYN exam and she experienced a terrible itching on her left arm on 24Jan2021. It was sudden and startled her. The itching was located just below the injection site at a spot where the skin was a little red, feathery red, just below the injection site. Now the itching has stopped but it is still red. she couldn't hardly feel it being injected, she doesn't usually have reactions to vaccines, she never had anything, but she has a few drug allergies, and she was separated out, she was flagged to wait 45 minutes after, instead of the 15. She does have an IV contrast reaction, and some other things, nothing she knew was in the vaccine, she was fine and wasn't worried that she was aware of. She thinks she got too hot, she had on a coat, she was sitting and panning through stuff, reading on her phone, and all of a sudden she had terrible lightheadedness, she never fainted in her life, she is pretty sturdy, she didn't know what to think, she was lightheaded, and it was not vertigo, not like the room was flying, but she was like out of balance, her balance was messed up, and she sat there a minute, she was too hot, she got out of her coat, and it got worse, she could feel her heart racing, and she was talking to herself, she thinks she nervous, she could feel her heart pounding, and was instructed to raise her hand if she had issues, so she raised her hand, a nurse practitioner came over, she raised her hand, and the doctor making rounds came over and he said take off your mask off, she did, that helped somewhat, it was that blasted mask, she couldn't get enough air, he gave her water, she thinks she got too hot and perhaps got nervous and didn't think she was she said she's not been around people, and was suddenly in a huge crowd, everyone was appropriately distanced, it was an extreme presentation, after 5-6 minutes, she was good, it went away, but for 36 hours she didn't feel right, she could feel sometimes her balance wasn't right, she was just not herself, she could do her usual, she lives on a farm, she did usual farm stuff, but was not herself, and in the night, she woke several times, her heart was beating too fast, too much, but she went back to sleep, and she told her son, she said it felt like she had had 4-5 cups of really strong coffee. So the next day she was ok. Absolutely her normal, and then she didn't think anything about it, and was driving to a routine GYN exam, which was canceled last moment due to an emergency, she was driving and suddenly her arm started itching, this was Tuesday, so 48 hours after, not the site, it was distal, underneath it, maybe 2-3 inches under injection site. The site did nothing, she looked that night, no redness, lump, no raised area, no warmth, nothing, but then she had itching, intense itching like poison ivy, and she scratched and thought wait a minute, at her appointment she looked at her arm, this area was 3-4inches under the site, that was red, feathery looking and flat, macular, not raised, no induration, no warmth, no lump, no pain, it was feathery dusty red and the next day it was gone, she did nothing to it, she thought to put hydrocortisone, and looked at it, but it was so faint and wasn't itching. The seriousness was reported as non-serious. The outcome of the events was Feeling hot was recovered on 24Jan2021; Heart rate increased; felt dizzy; Muscle pain; Sweaty was recovered on 25Jan2021; Feeling anxious was recovered on 26Jan2021; Vaccination site rash; Vaccination site erythema recovered in 2021. Vaccination site pruritus was recovering; Difficulty sleeping; Loss of balance, Nervous was unknown.
69 2021-02-23 weakness Violent chills Headache Profuse Sweating Nausea Diarrhea Light-headedness Weakness
69 2021-02-24 discomfort 2 hours after injection left leg from the knee down started to swell and the muscle turned rock hard... Read more
2 hours after injection left leg from the knee down started to swell and the muscle turned rock hard Severe pain made it impossible to walk The swelling is not going down and is causing great discomfort went to the doctor yesterday and it was determined there is a blot clot
69 2021-02-24 tingling Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their ... Read more
Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their arms, and chest pressure. EMS evaluated patient on-site. Patient was hypertensive (184/96). 12-lead EKG was NSR, rate of 79 bpm, no ST elevation. FSBG was 137 mg/dL. ETCO2 was 40mmHg with normal square waveform. EMS initiated transport to Hospital Emergency Department. En route, patient became more hypertensive (200/106). In ED, she remained hypertensive and was admitted to inpatient telemetry unit. Patient had 1-night stay to rule out cardiac-related events. Anaphylaxis was ruled out. Discharged with diagnosis of vaccine reaction and chest tightness.
69 2021-02-25 weakness, pain in extremity After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, sl... Read more
After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, slept all day, very weak, couldn?t remember what happen rest of day after booster (2-24) or then next day during sever reaction.(2-25) Day of shot arm hurt for several hours then went away. Day 3 still listless, tired, headache, foggy.
69 2021-02-25 weakness Awaken at 7 a.m. feeling sick and had to get to bathroom, sweating profusely, vomited, feeling very... Read more
Awaken at 7 a.m. feeling sick and had to get to bathroom, sweating profusely, vomited, feeling very faint, extreme diarrhea, lasyed almost 2 hrs before being able to get up and shower off and go to bed, chills for 2 days and extremely weak. Afraid to get the 2nd shot!
69 2021-02-25 tremor, feeling hot, weakness Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep th... Read more
Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021). Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes. Debilitating and confusing. Glad to have received the vaccine in any case (small price to pay).
69 2021-02-25 flushing Client c/o dryness of mouth, flushness to face, proceed by hyper salivation (spittle). Client verba... Read more
Client c/o dryness of mouth, flushness to face, proceed by hyper salivation (spittle). Client verbalized that she felt anxious and nervous about taking vaccine but started to feel decrease in sensation. Client seen by EMS and vitals are BP-168/89, Heart Rate76, O2-97. Client then cleared by EMS to go home.
69 2021-02-25 tremor Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appe... Read more
Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appetite, which persisted for about 24 hours. Low grade fever present Day 2 after vaccine administered.
69 2021-02-25 feeling hot February 21, 2021 around 4 pm, a woman on the passenger seat of a car, driven by her husband began ... Read more
February 21, 2021 around 4 pm, a woman on the passenger seat of a car, driven by her husband began feeling ? dizzy?. I was approached by our CIO to see her immediately. Another Nurse came to the rescue and we both assessed the patient. She was awake, alert, oriented but anxious and stating she's dizzy. The back of the seat was lowered down for her comfort and blood pressure was taken. It was 172 /100 mmhg. PR = 72 , Temp = 97.5. RR = 18. Two other RNs came to help. The patient was conversant, her husband was upbeat and being funny. Pt started to play with her dog from the backseat reaching for it. The patient was talking but I decided to tell patient to relax since vital signs will be taken again. BP repeated after 6 minutes and its now 155/100, PR= 75, RR=19, TEMP= 97.3, 02 Sat @89 % . Pt?s hands were cold now. O2 Sat was also hard to get a good reading on all of her fingers. Called Dr. Cat Forest and she came to the scene comforting patient while vitsal signs were repeated again after 5 minutes after they were taken Now getting BP= 55/110 mmhg, PR: 80, Temp 97.2 and O2 Sat still at 89% Pt was adviced to go the ER after the Patient?s O2 Sat stayed at 89% and also after finding out that patient haven?t had any physical for two years and that patient doesnt check her blood pressure. Pt and her husband were counselled on the importance of getting regular check up especially at her age of 69 years old. Husband drove patient to the ER per order. Called patient on Monday, 2/23 and Tuesday, 2/24 with no answer. emailed patient and patient answered back and she said that she went to the ER with her husband that day and was discharged and feeling better and wanting to thank the staff for the way she was taken cared of and hoping they will be there for her second dose when she comes back.
69 2021-02-25 pain in extremity Moderate soreness in left arm. I am a physician and I have heard from many friends who are elderly t... Read more
Moderate soreness in left arm. I am a physician and I have heard from many friends who are elderly that they had some significant arm pain for 3-4 days after the injection. I wonder if it is because we have had 2 injections in the same place 3 weeks apart. All of them say that the first shot did not hurt. Maybe the 2 shots should be given in different locations to alleviate the pain problem. Just a suggestion. It may be beneficial to study this as well as it would decrease adverse reports.
69 2021-02-25 pain in extremity Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sor... Read more
Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sore, body aches and backache all night. I took Bismuth 525mg at 9am, acetaminophen 1000mg at 11am, felt better for a few hours, took acetaminophen 500mg at 6pm.
69 2021-02-25 pain in extremity Woke up in middle of night with body aches, especially in my legs. Kept me awake for hours. I was ... Read more
Woke up in middle of night with body aches, especially in my legs. Kept me awake for hours. I was exhausted the next day. Aches and exhaustion subsided over 48 hours. After 2nd injection I experienced the same but milder reaction on the tenth day after the injection. However, I have been tired for a longer period of time. About 3 days.
69 2021-02-26 pain in extremity ACHY ARM; JOINT PAIN; HEADACHE; FATIGUE; DIARRHEA
69 2021-02-27 weakness MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the ... Read more
MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the first five minutes. I felt totally incapacitated, nauseous, lightheaded, "wiped out", generally drugged and ill. This lasted for about 45 minutes and then subsided. For the rest of the day I had periods off and on of feeling exhausted and tired.
69 2021-02-27 pain in extremity Soar arm, fatigue, low grade fever, chills
69 2021-02-27 weakness Within 10 seconds I began to feel that something was wrong. A full body response of a swirling con... Read more
Within 10 seconds I began to feel that something was wrong. A full body response of a swirling congestion, extreme weakness. very blurry vision and couldn't think straight. I had trouble walking to recovery room, felt nauseous and weak and had a very fast heartrate. I had to stay in private recovery room for 45 min. I was still very ill and nervous at this point. I left with a family member and asked to be driven to the nearby hospital emergency room. For a precaution . We parked across from ER entrance for another 1 hour till I slowly regained strength to 50% normalcy. I went home afterwards and had to go to bed. I was unable to drive my own vehicle home. Day 2, still feel weak, shaky and not normal. I consider this a serious adverse reaction that did not receive medical intervention but will prevent me from getting the second Pfizer shot. After 5 hours post injection I felt 60% normal . Day 2, 70 per cent normal. The vaccination facility was not able to do blood pressure monitoring ( which is a problem for anyone experiencing reactions.) They said their protocol was to call 911/ambulance. My blood pressure was checked by a certified PA with professional equipment at the 3 hour post injection time and the diastolic pressure was still below 50. And heart rate above normal. Still weak and nauseous.
69 2021-02-28 weakness Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nau... Read more
Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nausea, lack of appetite. That evening, awoke out of sleep at 3 am with extreme abdominal pain, walked to bathroom and almost passed out, had to lay on the floor for 15 minutes.. After a half our it happened again. No diarrrhea but had 2 soft formed stools (very unusual for me). A lot of nausea, weakness and abdominal pain. Chills for 2 days.
69 2021-02-28 numbness, tingling Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Feel... Read more
Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Difficulty swallowing; Throat started to feel like it was closing up; Tongue got thick; Little blurred vision; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 26Jan2021 at 15:46 PM, (at the age of 69-year) as a single dose for COVID-19 immunization. Medical history included hypertension, pacemaker insertion. Concomitant medication was not reported, however, the patient reported that she takes medicines for hypertension, and is on blood thinners. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on 26Jan2021, after receiving the vaccination she did wait a half hour and the only symptoms she thought at the vaccination visit was a little blurred vision, which was temporary and went away. At 16:30, about 45 minutes to 1 hour after she left the vaccination center, as she was driving home, she informed that she was feeling numbness in her face around her cheeks and mouth/face was really tingling and numb, and she had difficulty swallowing; her throat started to feel like it was closing up and her tongue was really thick. She stated she tried to stay calm and forced herself to drink a bottle of water. She had no idea where there was any emergency area since she was not familiar with the area and tried to calm herself down and took sips of water and made sure she was breathing okay and it all went away. The reaction lasted 10-15 minutes and seem to resolve when she was able to calm herself down. She stated it was scary, and once she calmed down it all went away. She was concerned about receiving the second dose. She did not go to a physician or emergency room, but says she probably should have. The clinical outcome of little blurred vision, feeling numbness in her face around her cheeks and mouth/her face was really tingling and numb, difficulty swallowing, throat started to feel like it was closing up, and tongue got thick was recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
69 2021-02-28 feeling hot Patient presents with vaccine reaction Had first dose Pfizer COVID vaccine and walked into waiting... Read more
Patient presents with vaccine reaction Had first dose Pfizer COVID vaccine and walked into waiting room for observation and started to feel like drank sometimes warm and then became dizzy shortly after that. Waited a couple minutes in waiting room and then told observer up front what she was feeling. Was asked if wanted a wheelchair to come back to examination room and patient declined and able to walk back down the hall accompanied by her husband. Denies nausea, abdominal pain, no SOB, no syncope, no recent illness, denies fevers cough, ill contacts Working wood burning project and was up till 3am and then unable to go sleep yet today. Also has stress with only child with being treated for stage 4 breast cancer Did eat breakfast around 9am- granola and cup of tea this am. Nothing since then. Current B/P 164/110 and then 10 minutes later was 150/86. Patient verbalized has history hypertension even with medication. Denies visual changes, denies headaches Vaccine reaction Symptoms resolved. Told patient if start to feel bad again let someone know (husband, COVID hotline, PCP). Increase fluids, discussed sleep hygiene.Patient and/or guardian verbalized understanding
69 2021-02-28 numbness, tingling She reported feeling like her throat was closing and was also experiencing lightheadedness, apprehen... Read more
She reported feeling like her throat was closing and was also experiencing lightheadedness, apprehension, and numbness/tingling in her left hand. Her vital signs were monitored every 5 minutes for 20 minutes, and she was given 20 mL (50 mg) of liquid Diphenhydramine. Her signs and symptoms subsided, and she was ambulatory and stable with no distress at dismissal from clinic.
69 2021-02-28 muscle spasms muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; pa... Read more
muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; headaches/The headache is above her ear and the pain is "past 10"; She recalled experiencing "swelling around her eyes" and "had some swelling" after the 1st dose of the Pfizer-Biontech COVID19 vaccine/left eye swelling; had some swelling; Dizziness/Lightheadedness; Vomiting; Blurry vision; She said the left arm pain started immediately after receiving the COVID-19; Injection site swelling; she is sweating something fierce under her arms; peeing on herself (running to bathroom more); lady asked her to call her when she got home, and she forgot, saying her mind wasn't there; acid reflux taste in mouth/she tasted the COVID-19 Vaccine shot when it was administered; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at the age vaccination of 69-year-old via an unspecified route of administration in the upper left arm on 19Jan2021 08:00 (also reported as 11Dec2020) at a single dose for covid-19 immunization. Medical history included was hit by a truck a GM and the truck busted her legs up, ongoing RSD (Reflex Sympathetic Dystrophy) pain since 1991 and was prescribed with oxycodone/acetaminophen (PERCOCET), rheumatoid arthritis from 1991 to an unknown date, spinal cord implant is in her spine, and goes from her spine to her waist, and from her waist to both legs, and down to her ankles from 1991 to an unknown date and migraine when she was 12 or 13 years old. There were no concomitant medications. She received the vaccine in a hospital. The patient previously had a flu shot for immunization but was allergic to the flu shot. It was reported that a patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine on 19Jan2021 08:00. On 19Jan2021, the patient reported that she said she had a slight headache, left eye swelling, dizziness, vomiting, blurry eyes, sweating up under her arms, and peeing on herself (running to bathroom more) after receiving the COVID-19 Vaccine. It was reported that the patient had injection site swelling on 19Jan2021. She said she has never had any side effects like what she is experiencing now after getting the COVID-19 Vaccine. She reported that her mild headache turned severe over the weekend, and she had to wrap a towel around the back of her head, so she could lay down. She said the headache pain was a sharp pain at the bottom of the back of her head and neck. She clarified she had migraines when she was 12 or 13 years old, but the headache pain she had now is nothing like the migraines she had then. She further clarified that her severe headache feels like a knife in the back of her head and neck. She said the pain is more severe on the right side of her head than the left. She said right now she has pressure in the front of her head with a slight headache. She additionally clarified that the swelling in her left eye comes and goes and is persisting. She said her left eye didn't swell close, but her granddaughter told her it looks like something is wrong with her left eye. She added that she had dizziness this morning when she was going to work. She said she stumbled when she was walking this morning but drove to work anyway. She said when she got to work, she wasn't feeling well on an unspecified date, so she decided to go back home. She said when she was walking to her car, she stumbled again, and fell against her car. She reported when she first got the COVID-19 Vaccine (19Jan2021), she was driving in a bad way. She said after she got her COVID-19 Vaccine, she picked up an elderly lady she sits with, and the elderly lady told her she wasn't normal. She said the elderly lady told her she was too relaxed while she was driving, like she was in a daze. She said the elderly lady said she was scared for her and herself when she was driving. She said the elderly lady asked her to call her when she got home, and she forgot, saying her mind wasn't there. She mentioned that she had to wait 15 minutes after receiving her COVID-19 Vaccine (19Jan2021), and when she was driving home, she had to pull over and get out of her car to vomit. She said she had an acid reflux taste in mouth before she threw up. She said she threw up a little bit last night when she had a severe headache. Clarified her eyes are constantly blurry now. She said she has to put her glasses on to see but has to turn her head sideways in order to see anything past her blurriness. She said her burry eyes are worse at night. She stated that she was sweating something fierce under her arms, she said she has to take 3 showers a day now to get rid of the sweating and smell under her arms. She said she has never sweated like that before. She reported her left arm is sore too. She said the left arm pain started immediately after receiving the COVID-19 Vaccine (19Jan2021). She said she has swelling too, and has been rubbing her left arm with alcohol, but the left arm soreness is still there. She reported that she tasted the COVID-19 Vaccine shot when it was administered. She has blown off calling her doctor when she first experienced her side effects, but then her headache got worse. She said she so spoke to doctor 30 minutes before calling Pfizer. She said she told her doctor if her headache comes back, she is going to the emergency room when she gets off work after tonight. She stated that she has been experiencing headaches/muscle spasms that have been getting worse. She says they last 15-20 minutes and then it stops. The headache is above her ear and the pain is "past 10". Yesterday night (unspecified date), the headache was so severe that she wanted to go to the ER but was too tired. The patient reported that she was taking ibuprofen (ADVIL) for her slight headache. She said she took the Advil for a couple days and nights, and her headache eased up some with the Advil. She reported that 2 days ago she bought aspirin, caffeine, acetaminophen (EXCEDRIN MIGRAINE). She also reported that she started taking Ibuprofen when her headaches became severe. She said the Ibuprofen eased the headache, but the headache comes back. Reported she took pain medicine prescribed from a doctor way back, and the prescription pain medication doesn't ease her headache pain. She clarified that the medication was dispensed in a pharmacy was oxycodone, acetaminophen (PERCOCET). She called her doctor when she returned home from work this morning, and her doctor told her to call Pfizer to report her side effects. She reported when she went to work this morning, she got lightheaded. She took Percocet and other medications, but it hasn't relieved it. She says it's not a migraine. She recalled experiencing "swelling around her eyes" and "had some swelling" after the first dose of the Pfizer-Biontech COVID19 vaccine on 19Jan2021. She reported on 02Feb2021 that she was calling back today to report that her headaches were worse. She said her headaches are not a migraine, but more like a muscle spasm in the right side of her head, above her ear. She said the pain is between her neck and ear on the right side of her head. She said the headache pain feels like it is as big as a golf ball. She said her headache pain is so severe, the headache pain wakes her up in a cry. She said the headache pain lasts 15-20 minutes, and then eases up slightly. She said the headaches have been happening twice at night, and twice during the daytime. She said the headache pain doesn't last long. She mentioned that she has been doing self-remedies. She said she ate a spoonful of mustard to ease the headache, and the spoonful of mustard did ease her headache. The patient inquired if she should get the second COVID-19 Vaccine if she is continuing to experience headaches after receiving the first COVID-19 Vaccine. The outcome of the events headache, eye swelling, blurry vision, frequency urinary were not recovered, as for the events dizziness, vomiting, vaccination site pain and vaccination site swelling were recovering, while the outcome of the other events was unknown.
69 2021-02-28 pain in extremity temp 100.4 HR 105 pulse ox 96 severe upper arm pain (both arms) Hallucinations !! se... Read more
temp 100.4 HR 105 pulse ox 96 severe upper arm pain (both arms) Hallucinations !! severe Headache neuropathy SEVERE Hands were like frozen
69 2021-03-02 burning sensation 9 pm noticed red puffy area on face with burning sensation Woke up 3/03 with headache
69 2021-03-02 facial pain, nerve pain At 2:00am, I had severe pain on the right side of my head...very severe headache, face pain, ear pai... Read more
At 2:00am, I had severe pain on the right side of my head...very severe headache, face pain, ear pain, jaw pain that included my teeth being very sensitive. Tylenol helped ease the pain. It lasted 13 hours. The following night, I had the same exact pains on the left side of my head that lasted 12 hours. For 2 days after, I had a few twinges of pain on the left side of face, mostly below the ear, didn't last more than a couple minutes.
69 2021-03-02 weakness Headache on only the left side of the head - treated with Advil 200 mg 4X daily. Lasted 11 days and... Read more
Headache on only the left side of the head - treated with Advil 200 mg 4X daily. Lasted 11 days and was worse late in the day. Fatigue and weakness for 48 hours.
69 2021-03-02 pain in extremity Pt developed a reddened rash over the left antecubital fossa approx. 10-15 min after she received he... Read more
Pt developed a reddened rash over the left antecubital fossa approx. 10-15 min after she received her vaccination. It was her first dose in the PFIZER series. Pt received her vaccination in the L arm and started noticing an itchy sensation to the left antecubital fossa. Realized it was reddened and alerted staff. This RN noted reddened rash, approx. 6 inches in length, with one raised hive to area. Pt denied any difficulty breathing or trouble swallowing/speaking. Pt was speaking in full sentences throughout whole event. Pt's vital signs were obtained with HR 70, 97% on room air for oxygenation, and BP 152/88. Pt was given 25mg of Benadryl PO by this RN. Pt was reassessed at approx. 0804 and noted that the itchiness was going away as well as the rash. She continued to hold conversation and denied any further symptoms. Redness within rash was fading and pt states she just had a slight burning sensation to the area. Repeat BP was 160/90. Pt was released home at 0815 with her husband. Rash improved and pt denied any further concerns or symptoms. recommended to get Benadryl to have at home in case needed.
69 2021-03-02 unresponsive to stimuli became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was ... Read more
became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient (reporter's wife) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 12Feb2021 on right arm at a single dose for COVID-19 immunisation. Medical history included diabetes diagnosed about 30 years prior. Concomitant medications were none. Patient got the 1st dose of bnt162b2 and 4 hours after getting it, her blood sugar went down to 25 (12Feb2021) and she became almost non-responsive. She took a lot of carbohydrates after the shot before she plummeted. Reporter asked if there had been any reports of this and should she take the 2nd shot. Reporter said that he is reporting the side effect of that approximately 4 hours after receiving the shot, which his wife is diabetic, she was tired and then her sugar dropped to 25 before he realized she had an issue. He says she was nearly totally nonresponsive (12Feb2021). He said this was very abnormal and her sugar has never been that low. He said after he realized her sugar dropped to 25, he got some ice cream into her and then some (brand name withheld), then he got her blood sugar which the next reading was 47, then the third reading was mid 90s, so then he took her to the emergency room and they ran tests. He says by then her blood sugar was 250-280, which they thought was good after it had been that low. He says that they did blood tests and did not find anything abnormal, and her blood sugar has been good since then. He said she was not admitted to the hospital, and they went home that night. He said that this had never occurred before, period. Reporter said that everything seems to be normal at this point, though it scared them. He said his wife has not gotten the second dose yet, and they have questioned if she should take the second dose since this happened, and he was wondering if Pfizer may have advice to provide them on getting the second dose for her. The outcome of events was recovered on an unspecified date.
69 2021-03-02 feeling hot felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to... Read more
felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to the floor and tried to take deep breaths, ...never lost consciousness"; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm, on 15Feb2021 at 04:45 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included trazodone (MANUFACTURER UNKNOWN) and letrozole (MANUFACTURER UNKNOWN). The patient previously took codeine (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, tetracycline (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, doxycycline (MANUFACTURER UNKNOWN for an unspecified indication and experienced allergies, and cyclobenzaprine hydrochloride (FLEXERIL) for an unspecified indication and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Feb2021 at 01:15, the patient felt hot, nauseous, and lost control of bowels. The events were reported as non-serious. The clinical course was reported as follows: About 8.5 hours (as reported) after the vaccination, the patient briefly felt hot and nauseous. She knew she would pass out soon, so she lowered her head to the floor and tried to take deep breaths. The patient lost control of her bowels but never lost consciousness. The episode was reported to be over in about 20 minutes. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered on 16Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
69 2021-03-02 tremor shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contact... Read more
shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contactable pharmacist. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 vaccination. Medical history included she was previously positive for Covid in Oct2020 to an unspecified date and she received monoclonal antibody treatment (Remdesivir) 3 months prior to her first dose of the vaccine; patient had COPD, oxygen dependent and diabetes from 2016 to an unknown date; and obesity in 2014 to an unknown date. There were no concomitant medications which was reported as patient had not had any other recent vaccinations or started any new medications. Patient received monoclonal antibody treatment 3 months prior to her first dose of the vaccine. Patient probably tested positive and was treated probably the same day she had the positive test (in Oct2020), reporter was sure all of this happened at the hospital, but he doesn't have that information, and the COVID test type was unknown. Reporter's question was related to information about this specific type of patient, having received the monoclonal antibody treatment on 12Oct2020, to an unknown date, which was Remdesivir and also having had COVID then, then having reactions to the dose, would the second dose be necessary, effective, or safe to give to this patient. The patient had her first dose of the Pfizer Covid vaccine 3 weeks ago (estimated as 27Jan2021 by standing order and not prescribed). The patient had general same symptoms listed for side effects of the vaccine that were more severe than others. The patient experienced effects after the first dose of the vaccine as shaking and chills for two days, and headache, diarrhea, and overall body aches (Jan2021). Reporter wanted to know of any studies or research on patients who have been positive for Covid 19 prior to getting the vaccine and treated with monoclonal antibodies and if they do have similar titers to those who have been vaccinated. The reporting pharmacist that the events were serious, and he thought these were medically significant. The patient's symptoms resolved after 72 hours, and reporter did not believe that they did any treatment other than to sleep. The events recovered on an unspecified date in 2021. Information about Lot/ Batch number requested; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tremor, chills, headache, diarrhoea and pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
69 2021-03-02 weakness, hot flush she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing... Read more
she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing in the ears; Hot flashes; Blood pressure went up; Was so dizzy if she moved her eyes she would nearly pass out; Was so dizzy if she moved her eyes she would nearly pass out; Very weak and tired; Very weak and tired; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3247; expiration date: unknown) at vaccination age of 69-year-old via an unspecified route of administration left arm on 28Jan2021 10:00 at a single dose for To keep from getting COVID (covid-19 immunization). The patient medical history was none. The patient's concomitant medications were not reported. The patient stated that she got the first vaccine the other day and within 12 hours (28Jan2021 22:00), she was not feeling well. At 8:30 the next morning (29Jan2021), she was sick for about 8 hours. She was throwing up, had a headache, chills, ringing in the ears, hot flashes, her blood pressure went up, she was unable to get anything down, not even medication [pending clarification]. She was so dizzy if she moved her eyes, she would nearly pass out. She could not move out of the chair for about 6-8 hours. The dizziness was severe and awful. She added only one ear is ringing really bad, the right ear. It is off and on and persisting. Her very weak and tired which was persistent. One hour it may be bad and the next she will be drained. The patient inquired if it is true since she heard the second dose is worse. She also wants to know if she should get the second dose or not. The received treatment for the adverse events was reported as none [pending clarification]. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement) was reported that her blood pressure went up and recovered on 29Jan2021, and weight was 175-180 pounds on an unspecified date. The outcome of the event feeling unwell was unknown, as for the events weakness, tiredness and ringing in ears were not recovered, while the outcome of the other events was recovered on 29Jan2021. Information about Lot/Batch number has been requested.
69 2021-03-02 pain in extremity sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness a... Read more
sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness and tingling of lips and tongue; Back began to itch; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 01Feb2021 14:30 at a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, IBS, indigestion, heart burn, colon polys removed, Morton neuroma, torn meniscus left and right, total hyst with bilat oophorectomy and tonsils removed, Shellfish allergy and many medication allergies. Concomitant medication included metoprolol, hydrochlorothiazide, colecalciferol (VIT D3), zinc and pyridoxine hydrochloride (B6). The patient previously took epipen for shellfish allergy. Sat in waiting area 15 minutes as directed. After leaving in car about 10 min. Into ride home she experienced numbness and tingling of lips and tongue on 01Feb2021 15:00. Eventually subsided by 5 pm. Back began to itch, no rash nor hives subsided in about 10 min. Sore arm started about 17:00. Slight headache during night and sore arm continued esp. to lay on left arm impossible. At 8:18 a.m. still sore arm. Cannot raise above my head. No swelling in arm at injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events numbness and tingling of lips and tongue and Back began to itch was recovered on 01Feb2021 while outcome of the other events was not recovered.
69 2021-03-02 pain in extremity tired; very sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 69-y... Read more
tired; very sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Feb2021 at 14:30 at a single dose, for COVID 19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility where vaccine was administered was reported as "other". On 12Feb2021, the patient had a very sore arm. The patient was tired the next day (13Feb2021). The patient did not receive treatment for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.
69 2021-03-04 feeling cold Jittery a few minutes after the injection that went away Tiredness that lasted about 3 days Cold for... Read more
Jittery a few minutes after the injection that went away Tiredness that lasted about 3 days Cold for about 4 days but no fever Headaches that were nagging for about 4 days Diarrhea the first that did not last long Nausea that lasted for about 2 eqyw
69 2021-03-04 flushing, feeling hot Pt reported rapid heart rate to EMT at 1410. EMT assessed pt. HR: 82 and no SOB. Pt reported hx of h... Read more
Pt reported rapid heart rate to EMT at 1410. EMT assessed pt. HR: 82 and no SOB. Pt reported hx of hypertension, allergies to PCN, and severe allergic reaction to flue vaccine 2 years ago. Pt offered adult dose of diphenhydramine. Pt refused diphenhydramine. Pt offered EMS. Pt denied EMS. Pt advised to wait 15 extra minutes. At 1417 pt reported dry throat and feeling hot. Flushing was observed by RN. Pt was moved outside. Pt was offered EMS for a second time. Pt agreed to EMS. EMS was activated at 1420. EMS arrived at 1430 and assumed care. Pt left vaccination site at 1435 and transported to ER.
69 2021-03-04 tremor TACHYCARDIA, NAUSEA STARTING APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF THE 2ND DOSE. ALSO EXP... Read more
TACHYCARDIA, NAUSEA STARTING APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF THE 2ND DOSE. ALSO EXPERIENCED TREMORS GENERALIZED BUT WORSE IN HER HANDS WHICH STARTED APPROXIMATELY 25 MINUTES AFTER INJECTION OF COVID-19 (PFIZER) VACCINE.
69 2021-03-07 migraine Experienced severe chest pain Severe migraine Pain in neck and back. Took ambulance to hospital B... Read more
Experienced severe chest pain Severe migraine Pain in neck and back. Took ambulance to hospital Blood pressure was extremely high
69 2021-03-07 tingling, numbness, discomfort, pain in extremity My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting o... Read more
My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting on Saturday, the day following the vaccination} in a sore right wrist and a much more painful right arm that steadily grew in intensity and spread rather rapidly into my upper torso. By the following day (Sunday, 2/21) my breasts became very sensitive and I had severe pains across my back. This may or may not have been the beginning of a banding type MS exacerbation, but by Monday, 2/22, it was clear that I was experiencing a full-blown and seriously disabling exacerbation. Both legs experienced the tingling and numbness I have had in a prior exacerbation, and by the time I was able to talk to Dr. (my neurologist) on Monday afternoon (2/22), the numbness had progressed upward into my lower abdomen and I was no longer able to stand at all. It appears highly likely that the MS attack was triggered by the response of my immune system's reacting to the discomfort and severe body pains that occurred following the vaccination. I told Dr. of the total loss of feeling and use of both legs and was experiencing a increasing numbness from toes up to abdomen. Before ordering the high doses of corticosteroids used to stop my exacerbation, Dr. sent me to the Emergency Room for testing to make sure I did not have an infection that could be covered up by the steroids. When this testing did not show any such infection, the ER administered an IV infusion of 1 gram of solumedrol, followed by gradually decreasing high oral doses of prednisone. As of this date, numbness has started decreasing and some limited utility of right leg has returned. Still i can no longer stand and perform even the minimal movements to-and-from wheelchair to bed or toilet without substantial physical help (not needed before this exacerbation) from my sole caregiver, my husband.
69 2021-03-07 numbness two days after receiving the vaccination my left arm went numb. the next am i went to urgent care an... Read more
two days after receiving the vaccination my left arm went numb. the next am i went to urgent care and they said pinched nerve - no improvement so went to ER on Monday morning. It was determined that the arteries in my left arm were completely blocked and I was not getting any blood flow to limb. Sent from ER and within hours an emergency throbectomy was performed to save my left arm/hand. Spent a couple days in ICU, total 5 in hospital. Doctors DO NOT KNOW if COVID 19 vaccine could have caused or be partially responsible so they advised me to file a report.
69 2021-03-09 pain in extremity Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left a... Read more
Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 69-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number reported as "ELI283 or EL1283"), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and cholesterol (abnormal). Concomitant medications included blood pressure medication and cholesterol. The consumer was reporting on behalf of his 69 year old wife. She received the first dose of the BNT162B2 vaccine on 30Jan2021. On 06Feb2021, she started to experience itchiness, a rash, and a big area of redness on her left arm which was the injection arm. He stated he heard that the second dose can cause more side effects and he stated they both experienced arm soreness after the first dose on an unspecified date. Consumer stated, first of all thank you guys for making this vaccine. He and his wife received the vaccine (unspecified vaccine) their first dose last Saturday, a week ago yesterday and had no reaction to it at all, their shoulder was a little sore but that's it. Yesterday night, last night his wife noticed that the arm where she had the vaccination it has like a rash and he knows this online that Moderna has something called COVID arm but it doesn't say anything about Pfizer. He meant it's not to bother it itches a little bit you put some anti-itch cream on it wasn't a big deal. He was kind of concerned about the next you know they got the next one coming on the 18th, so, does she should change arm, do it on the other arm. Consumer added that that would be fine, he knows you guys want to know if there was any reaction so that you can log it in and that was basically why he called. They were going for their next shot they were going to the hospital and there were professionals there so pretty much ask them what they should do. Should they change arm or nothing to worry about if they do it again that was not the problem he just wanted to let you guys know that there was some kind of reaction a rash. Consumer stated he just put Cortaid cream on it and itch went away. The patient underwent lab tests and procedures which included lab work on 27Jan2021: doctor did for cholesterol, blood pressure reasons and everything was fine. The outcome was recovered for the event itchiness; and unknown for the rest of the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170691 same reporter and drug, similar events, different patient
69 2021-03-09 breast pain her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; ... Read more
her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; thought she pulled a muscle at first; tired; not sleeping well due to the pain; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9267), via an unspecified route of administration on the left arm, second dose on 17Feb2021 at single dose, for COVID-19 vaccination. The patient's medical history was not reported. There were no concomitant medications. Patient took the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine (Lot: EL9264) on 27Jan2021 for COVID-19 vaccination. Patient got her second dose of the Pfizer Covid vaccine 17Feb2021 and experienced side effects such as painful lymph node and breast pain on 18Feb2021. She said that her lymph node in her breast is killing her on the side that she had the vaccine. She clarified that it is very painful and her breast itself is very painful. She said that she did go to the doctor to be sure that is what it was. She further reported that by Thursday night (18Feb2021), it started bothering and her breast started bothering her. She thought she pulled a muscle at first. She said that it has progressed and got worse and that Sunday night she was in agony. She called the doctor Monday for her left breast that hurts. She said that she is taking ibuprofen (ADVIL, Lot: DJ6716, Expiration: Dec2022), taking 3 of them at a time, but it is not really helping. She had no reaction at the injection site. It is not red and you cannot see anything there. She said that is why she is not even sure. She said that there was no pain at all there. She said that there is nothing wrong with her and she does not feel sick, she just hurts. She said that she was tired because she is not sleeping well due to the pain. Patient wants to know what pain medication she could use that will not counteract the vaccine. The outcome of the events was not recovered.
69 2021-03-11 weakness Hypotension leading to septic shock and DIC. Started 6 hours after injection. Discharged from hos... Read more
Hypotension leading to septic shock and DIC. Started 6 hours after injection. Discharged from hospital on 2/24/21. Left with much worse dementia. Weakness progressed. Now on hospice
69 2021-03-11 inability to speak Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressi... Read more
Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressively worse - endorsed fever, diarrhea, body aches, trouble breathing, lack of appetite. On 3/2/2021 pt and husband presented to ED. Pt's husband stated that pt had become more and more confused since she received the vaccine and that on 3/2 she could not complete her sentences. Temp 101.6 on arrival, tachycardic in 130s, tachypneic in 120s, but not hypoxic. Patient was given acetaminophen on arrival. IV was inserted and patient was given 1 L intravenous fluid replacement as well as 2 g ceftriaxone for broad-spectrum coverage within 3 hours of arrival. Blood work was drawn that shows no leukocytosis but lactic acidosis to 3.3. There are multiple electrolyte abnormalities, hyponatremia 127, hypokalemia 2.8, creatinine 1.01, ALT 59 AST 53, ALP 136, total bili 1.3, lactic acidosis 3.3, troponin 0.02. Patient was given 40 mEq of oral potassium. Additional L of normal saline was given for total of 2 L normal saline bolus. Chest x-ray shows right basilar pneumonia. Also shows pulmonary nodule of which husband was made aware. LFTs are noted be elevated, so biliary ultrasound was obtained that was negative with limit to body habitus. Husband was updated. Azithromycin was added on. Rapid COVID antigen was negative. 3/3/21: Febrile, SOB overnight. Pt more lethargic, trailing off in the middle of sentences and having difficulties following conversation. Continue sepsis protocol, add vancomycin IV to ceftriaxone and azithromycin. Frequent neuro checks. MRCP. Chest pain-free, serial cardiac enzymes from yesterday to demonstrate nonischemic pattern likely type 2 NSTEMI. 2/2 blood cultures from 3/2 positive for Streptococcus pyogenes (Group A). Vancomycin and azithromycin dc'd. 3/11: Discharged from hospital. Patient admitted for acute hypoxic respiratory failure secondary to right basilar community-acquired pneumonia. Blood culture grew Streptococcus pyogenes, patient was initially treated with ceftriaxone and switched to Ancef . repeat blood culture on 03/04/2021 showed no growth. Patient will complete a total 14 day course of antibiotics with amoxicillin from culture negative date. Patient had right-sided pleural effusion, pulmonary consulted and she underwent thoracentesis x2 culture showed no growth, considered parapneumonic effusion. Patient required 2 L continuous oxygen and deemed stable for discharge. She will follow up with Pulmonary in 3 weeks, outpatient chest CT in 4-6 weeks to be ordered by Pulmonary to assess lung nodule and known thoracic aortic aneurysm. PTOT recommended home discharge with VNA. On discharge patient was a febrile and hemodynamically stable. Remained COVID negative throughout.
69 2021-03-15 feeling cold Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirs... Read more
Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.
69 2021-03-18 pain in extremity Cold; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 69-ye... Read more
Cold; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number LC3302), via an unspecified route of administration in the left arm on 12Feb2021 at 17:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included diabetes (diagnosed 4-5 years ago). The patient did not have any relevant family medical history. Concomitant medications included echinacea and vitamins, both from an unknown date at an unknown dose for an unknown indication and unspecified medications for diabetes, cholesterol and thyroid, all started prior to the vaccine. The patient previously received a shingles shot (unspecified product) for immunization and experienced injection site soreness. The patient did not receive any other vaccines on same date of the BNT162B2 vaccine and no prior vaccinations within 4 weeks of the vaccine. On 12Feb2021 the patient experienced a cold approximately five hours after the vaccination (reported as 21:30 - 22:00) which was a little worse on Saturday but started to get better and a sore left arm within a few hours of receiving the vaccine (exact time unknown). The events did not require a visit to ER or physician's office and there were no relevant tests performed. The patient stated they have not had a cold in over a year and would like to know if it is a symptom of the vaccine. The patient reported she is taking echinacea liquid and it usually helps within 36 hours and now this is her third day. It has gotten better because she takes echinacea and vitamins as well. The patient stated her left arm was sore, but not bad. She first stated it was 3-4 inches above elbow and later stated it was about 4 inches from shoulder and she did not think it was in the muscle. The patient has an appointment for her second dose in 4 weeks, the patient inquired if there will be an issue with her receiving second dose in 4 weeks instead of 3 weeks. The clinical outcome of the cold and sore left arm was recovering.
69 2021-03-18 hot flush crazy blood pressure fluctuations the highest was 188/89/BP was around 159 or 150 then it came down ... Read more
crazy blood pressure fluctuations the highest was 188/89/BP was around 159 or 150 then it came down to 136/71; feeling real jittery; hot flush feeling like an adrenaline rush in her upper chest and arms; heart pounding/highest pulse was 106; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EM5318), via an unspecified route of administration, administered in the left upper arm on 09Feb2021 at 11:00 at a single dose for COVID-19 immunization. Medical history included premature ventricular contractions (PVC) from an unknown date wherein her pulse goes up into the 120s and had to go to the ER. There were no concomitant medications. The patient previously received Pneumovax 23 on 14Jan2021. The patient called about the Pfizer COVID 19 vaccine. The patient had the shot on 09Feb2021 and the 10th she was fine then on 11Feb2021, she started having side effects. She is calling it side effects but what she is describing, she has these episodes periodically but she has not had one in 2 years but it was bad one and it happened 2 days after her vaccine, she is not sure if it was side effect but she doesn't want to mess with it so she wants to tell someone. On 11Feb2021, the reaction started around 1:30 PM. She started feeling real jittery, she was hot flush feeling like an adrenaline rush in her upper chest and arms down to her elbows. She could feel her heart pounding and she had these before but no one seems to know what causes it. She worked with it she was busy doing other things then around 4PM that day it started getting worse. She could tell her blood pressure was getting involved. She started taking her blood pressure, from 4:30 on until 12:30AM she had crazy blood pressure fluctuations the highest was 188/89 and the highest pulse was 106 but it goes up to 188 and then it would be 158, 179, 155, 119, 166 and those are the top number of the blood pressure. Her pulse pretty much stayed high 80s 90s except for the time it was 106. After midnight, her BP was around 159 or 150 then it came down to 136/71 and her pulse was 78 and she slept much better, she slept for 4 hours she woke up feeling like heart pounding but her blood pressure was 125/69 and her pulse was 74. She also has PVC and sometimes they say when she feels her heart pounding and her blood pressure and pulse are fine, they said that is probably PVC. When her blood pressure and pulse goes way up she is miserable. She had it so that her pulse goes up into the 120s with this and she has had to go to ER before. She clarifies her pulse being in the 120s and having to go the ER was in the past, prior to the vaccine. She says no one can figure out what it is. Some said it was anxiety, she sat through a whole program on anxiety and they decided not that is not what it is. But the fact that she hadn't had one of these episodes in 2 years and she had a good sized one 2 days after the vaccine, she had a really hard one that is why she thought she better report it. It has definitely gotten better she still feels jittery and heat flush every once in a while, but her blood pressure is fine. It is 139/74 and pulse 74. She can tell its still there but improved and certainly not uncomfortable. The events did not require a visit to the emergency room or the physician's office but she contacted her doctor's office and she has an online thing with them in a half an hour from the time of the report. The outcome of the event crazy blood pressure fluctuations the highest was 188/89/bp was around 159 or 150 then it came down to 136/71 and heart pounding/highest pulse was 106 was recovering while the outcome of the events feeling real jittery and hot flush feeling like an adrenaline rush in her upper chest and arms was unknown.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event blood pressure fluctuation cannot be excluded. The cardiovascular medical history is likewise a risk factor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
69 2021-03-19 weakness, feeling cold, pain in extremity, tremor After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shakin... Read more
After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shaking body, had to call 911 , in hospital was diagnose with Atrial Fibrillation, did not have this problem before!! Have to take 4 new medications for the rest of my life!!! I may experience stroke in the future. For a early few days had pain in my left arm. For the next few weeks overall tiredness. strange feelings in my head!!!!
69 2021-03-20 muscle spasms I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but fe... Read more
I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but feeling like I do I can't work; a slight temp 90.2; had choking episodes; feels like her throat is closing up when she is eating; Food get stuck in my throat; sleeping all day; tired; Headache; Nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 05Mar2021 as single dose for COVID-19 immunisation. Medical history included food allergies and meds allergies, anxiety, depression and blood pressure (abnormal). Concomitant medications included clonazepam (KLONOPIN) taken for anxiety from 2001, buspirone (BUSPIRONE) taken for anxiety from 2001, bupropion hydrochloride taken for depression from 2001, bupropion hcl taken for depression from 2001, and amlodipine besilate taken for blood pressure abnormal from 08Mar2021. On 05Mar2021 19:00, the patient experienced headache, and nausea. On 06Mar2021 19:00, the patient experienced sleeping all day, and was tired. On Day 2, she still had more side effects which wake her up. On 10Mar2021 19:00, the patient experienced had choking episodes, feels like her throat is closing up when she was eating, and food got stuck in her throat. On an unspecified date, the patient was upset and muscle spasms felt like something crawling in her leg and felt "crap"; she got to work but feeling like can't work. The patient reported that she had been having side effects and she was scared to have the shot because of her side effects and have when her body don't recognize it. She was asking when they go away. She has had a headache and nausea, was tired and sleeping all day. She felt like her throat was closing up when she eats. She had a choking episode and her grand daughter had to hit her on her back. She had choking episodes last night and this morning and she was now eating soft foods. She saw her doctor Monday for a regular appointment and she told him what happened. He wanted her to take the second dose but she was afraid to take it. She was afraid she will have worse side effects. Right now, she had nausea and drinking ginger ale. Her doctor called her which she was upset because he haven't seen her at all. Last time was 2019; and she just told him how she feel and want person to person. Patient reported she was not going to take 2nd dose because she do not want to go through anymore side effects. Everyone said that there were no side effects. That's wrong and she was having side-effects from day 1 on Friday night. There was an ingredient which she has allergies to. She told the nurse all meds allergies and food allergies which they told her that nothing in it will cause any side effects. They were wrong. She felt crap and she got to work but feeling like she can't work. Patient refused to take 2nd dose. Patient stated that she do not want to go through what she was going through now. The patient reported that she had a slight temp 90.2 on an unspecified date. The events required a visit to the physician office. The patient had no prior vaccinations (within 4 weeks). Outcome of events choking episodes, nausea, tired, feels like her throat is closing up when she was eating, Food get stuck in my throat was not recovered; sleeping all day was recovered on 07Mar2021; headache was recovered on 10Mar2021; and outcome of the rest of events was unknown.
69 2021-03-21 inability to speak Stroke - globus pallidus area Lost ability to speak and recognize objects. Immediately taken to ER... Read more
Stroke - globus pallidus area Lost ability to speak and recognize objects. Immediately taken to ER and evaluated and TPA given. Results good following drug administration sent home after two days. Some mental affects still.
69 2021-03-22 involuntary muscle movements, speech disorder seizure like symptoms; she was drooling; Incoherent; was making a bazooka sounding noise; arms and l... Read more
seizure like symptoms; she was drooling; Incoherent; was making a bazooka sounding noise; arms and legs shot straight out; This is a spontaneous report from a contactable consumer reporting for their sister (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 69-years-old, via an unspecified route of administration, administered in arm right on 24Feb2021 (lot number: EL1269, expiry date not reported) as single dose for covid-19 immunisation. Medical history included stroke from Sep2020 to an unknown date, cognitive impairment from having stroke, chorea movement of the mouth (she is on medication), blood pressure, cholesterol, anxiety, blood thinner, bones, mouth movements and tooth cleaning from an unknown date and unknown if ongoing. Concomitant medications included ongoing amlodipine at 2.5 mg, daily taken for blood pressure abnormal; ongoing rosuvastatin at 20 mg, daily (has been taking for years) taken for blood cholesterol abnormal; ongoing aspirin [acetylsalicylic acid] from Sep2020 at 81 mg, daily (was on a higher dose but was decreased); ongoing sertraline from Oct2020 at 25 mg, daily taken for anxiety; olanzapine from 20Jan2021 at 2.5 mg, unspecified date at 5 mg, 7 mg, and from 17Feb2021 and ongoing at 7.5 mg, daily taken for mouth movements; ongoing alendronate sodium at 70 mg, weekly (has been taking for years) taken for bone disorder; ongoing apixaban (ELIQUIS) from Sep2020 at 5 mg, daily taken for anticoagulant therapy. It was reported that the patient received the first dose of the Covid-19 vaccine on 24Feb2021. Four days later on 28Feb2021, she had seizure like symptoms. It was not a seizure but it looked like it. She is not sure if this is related. The doctors ruled it out. They said it would be immediate. This could be a coincidence. She is on medication for Chorea movement of the mouth. She was taken to the emergency room and she was admitted to the hospital. Her arm did not even hurt. She was incoherent for about an hour. Things seemed to calm when they gave her IV fluids. Her arms and legs were straight out until she went to the emergency room. She made a noise that sounded like a bazooka. It lasted for a little while. The gave her fluids and took her vital signs. Her arms and legs were no longer stuck out. She was calm when they laid her on the table in the emergency room. It was also reported that the patient was drooling. It was reported that they ran all kinds of tests, MRI, EKG, brain wave thing, unable to find any sign of seizure. Her arms and legs shot out and she sounded like an automatic gun, "ah, ah,ah,ah, us". She told them in the hospital, that she had the covid vaccine, and they said no, it was not that because it was to long after the vaccine. The patient was hospitalized for seizure like symptoms from 28Feb2021 to 03Mar2021. The patient underwent lab tests and procedures which included computerised tomogram: normal, electrocardiogram: normal both on 28Feb2021, magnetic resonance imaging: negative on 02Mar2021, scan brain: normal on 01Mar2021. Therapeutic measures were taken as a result of incoherent and was making a bazooka sounding noise which included IV fluids. The patient recovered from seizure like symptoms, was making a bazooka sounding noise, arms and legs shot straight out on 28Feb2021, from incoherent on 01Mar2021, while the outcome of drooling was unknown.
69 2021-03-24 flushing Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and c... Read more
Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and chest pressure. EMS evaluated the patient on-site. The patient was hypertensive (223/180). EMS administered O2 2lpm via nasal cannula. In the ED, the patient reported they felt flushed with a headache. They remained hypertensive (167/89). ED physician admitted patient to inpatient telemetry unit for 1-day. Discharged with diagnosis of chest tightness with associated SOB and palpitations, reproducible on palpitation, troponin negative and EKG with no acute ST-T wave changes, no arrhythmia noted on telemetry, low likelihood of acute coronary syndrome. Patient was instructed to follow-up outpatient for PET stress test and 2D Echo.
69 2021-03-24 tingling, numbness she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands, sta... Read more
she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes; numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes.; she was getting intermittent headaches; This is a spontaneous report from a contactable Physician reported for a patient. A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 17Feb2021 (Lot Number: EN6201) at age of 69-year-old at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medication(s) included atorvastatin (LIPITOR). The patient previously took first dose of bnt162b2 on 27Jan2021 (Lot number=EL3262) at single dose for COVID-19 immunization. On 20Feb2021, she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands. She reported after few days he started noticing in her bilateral toes. Patient also reported that she was getting intermittent headaches on 20Feb2021. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for 1 day. It was unknown if any treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab SARS-CoV-2 Antigen: negative on 08Mar2021. The outcome of the events was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events paraesthesia, hypoaesthesia and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
69 2021-03-27 pain in extremity Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and ... Read more
Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
69 2021-03-27 seizure mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; jo... Read more
mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
69 2021-03-29 involuntary muscle movements Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or w... Read more
Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or walk, altered vision (white picasso slides),
69 2021-03-31 bell's palsy Bells Palsy - no patient history of same
69 2021-03-31 weakness Within 1 day she felt body ache (typical), but within a few days she became weaker and weaker. With... Read more
Within 1 day she felt body ache (typical), but within a few days she became weaker and weaker. Within 1 week she could no longer walk. She was admitted for 5 days due her inability to ambulate. She continues to have weakness but now also orthostatic hypotension (previously she had hypertension--so all of her hypertension medications were stopped/changed since her symptoms are so profound--BP 68/32 at times!)
69 2021-03-31 weakness paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chil... Read more
paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chills; fell; This is a spontaneous report from a contactable Physician. A 69-year-old female no pregnant patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 10:30 AM at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included prior spinal cord trauma with rt foot drop. No Known allergies. No COVID prior vaccination. The patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 69-year-old, via an unspecified route of administration at single dose for COVID-19 immunisation. The patient started the next day on 11Mar2021 02:00 PM, after the 2nd shot with headache, fever 101.2 and weakness. Took Tylenol and went to have a nap. She woke up with still fever and chills, when she tried to get up she fell. She was currently in the hospital, paralyzed with no sensation at all in her legs till her waist. AEs resulted in Emergency room/department or urgent care, Hospitalization for 5 days, disability or permanent damage. Lab data included Nasal Swab on 11Mar2021: Negative. No COVID tested post vaccination. Solumedrol 1000mg IV were received. Treatments were received for the events. Outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-04-01 weakness 3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal... Read more
3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal swab was positive for SARS-CoV-2 and she was diagnosed with COVID-19. 3/17 She presented to ED w/ cough, HA, weakness and decreased appetite. Room air pulse ox was 88%. She was found to have bilateral infiltrates on CRS and was hyponatremic. She was admitted to the hospital on oxygen and decadron.. On 3/18 she was weaned off oxygen. She was discharged to home on 3/19 to complete a 10 day course of decadron.
69 2021-04-01 tremor Lung disorder; Post procedural complication; Shaking; Feeling down; Tiredness; This is a solicited n... Read more
Lung disorder; Post procedural complication; Shaking; Feeling down; Tiredness; This is a solicited non-interventional study report from the marketing program received from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in Jan2021 (Batch/Lot number was not reported) as single dose, second dose intramuscular on 15Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; adalimumab (HUMIRA, Solution for injection in pre-filled syringe), subcutaneous from 2015 (Batch/Lot number was not reported) to 2020, at 40 mg (40 mg,1 IN 2- 2), subcutaneous from 2020 (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 IN 2- 2) for Moderate To Severe Rheumatoid Arthritis and lupus. Medical history included hatal hernia, blood clots on legs were not worsened with Humira, non smoker, abstains from alcohol, allergy to latex manifested by rash, allergy to Sulfa drugs manifested by upset stomach. Concomitant medications included lisinopril (LISINOPRIL) taken for blood pressure, start and stop date were not reported; ezetimibe (ZETIA) taken for blood cholesterol, start and stop date were not reported; folic acid (FOLIC ACID) taken for rheumatoid arthritis, start and stop date were not reported; esomeprazole magnesium (NEXIUM) taken for hiatal hernia, start and stop date were not reported; apixaban (ELIQUIS) taken for blood clots on legs, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; proline (PROLIN) taken for an unspecified indication, start and stop date were not reported; tramadol (TRAMADOL) taken for pain, start and stop date were not reported. The patient experienced lung disorder on an unspecified date with outcome of not recovered, post procedural complication on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of not recovered, tiredness in Jan2021 with outcome of recovered in Jan2021, feeling down on an unspecified date with outcome of unknown. Clinical course: Solicited report by a consumer of a 69 year old female with events of small tumor on thyroid, blood clot on both legs, coughing and shortness of breath and non-serious lungs issue caused by methotrexate, after surgery shaking a bit, tired and cloudy weather caused to feel down a bit with HUMIRA 40MG/0.4ML (ADALIMUMAB). The patient had a relevant medical history of hiatal hernia and blood clots on both legs. On unknown dates, the patient experienced lungs issue caused by methotrexate, after surgery shaking a bit and cloudy weather caused to feel down a bit. In 2016, the patient experienced blood clot on both legs. In Sep2020, the patient experienced small tumor on thyroid. On 01Sep2020, the patient experienced coughing and shortness of breath. In Jan2021, the patient experienced tired. In Jan2021, the tired resolved. Methotrexate and covid-19 vaccine were also considered suspect. In Sep2020, the patient was admitted in hospital for cough, shortness of breath and was treated with unknown oral and intravenous antibiotics. While she was in the hospital, it was discovered that she had a tumor on her thyroid. She had stayed a week in hospital. She also had a lung issue. It was discovered lots of scar tissue on lungs and according to the physician it might be from patient's lupus, rheumatoid arthritis or methotrexate. The physician said that it was caused by the methotrexate not the Humira. Methotrexate was stopped for her. Patient denied to have pulmonary fibrosis and said that according to her doctor she did not have it and she did not know her diagnosis as it was not discussed with her doctors. For problems in lungs, patient was on oxygen. Patient was off of Humira for three weeks. She had surgery on thyroid biopsy. After the surgery she was shaking a bit. She thought it was because of the anesthesia but she was fine shortly after. The biopsy results were inconclusive which looked like it was not cancerous but physician could not really tell patient if it was or it was not. On unknown date in 2020, patient had restarted Humira again. On 04Dec2020, patient had thyroid tumor removed and was on oxygen until 11Jan2021. Sometimes the cloudy weather caused patient to feel down a bit. She did not have any paper work for the blood test. It was unknown if patient was enrolled in a covid-19 vaccine trial. In Jan2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer. On 15Feb2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer. The reported events except for coughing were serious as medically significant. The patient underwent lab tests and procedures which included biopsy: inconclusive in Oct2020 and in Dec2020, biopsy of tumor: inconclusive in Sep2020, blood test: unknown results in 2020, computerised tomogram of chest: unknown results in Oct2020, COVID-19 TEST: negative in 2020 and in 2020. The action taken in response to the events for bnt162b2 was not applicable, for methotrexate sodium was permanently withdrawn on an unspecified date, for adalimumab was dose not changed. The reporter's assessment of the causal relationship of the events with the suspect products bnt162b2 and methotrexate sodium was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities. Information on Lot/Batch number has been requested.; Sender's Comments: Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of events, cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-04-01 burning sensation, numbness face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneou... Read more
face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration, administered in right arm on 05Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and stroke. The patient is not pregnant. It was not sure if there were known allergies. The patient did not receive other vaccine within 4 weeks prior to the COVID vaccine but took other medications in two weeks (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medication. On 05Mar2021, within one hour of the vaccine, the patient experienced face numbing burning, sweating, fast heart beat and numbness on face that will not go away all day every day since the vaccine. The events resulted in Emergency room/department or urgent care and eventually hospitalization on an unspecified date for 2 days. It was unknown if treatment for the events were given. The patient underwent COVID test post vaccination via Blood test/ CBC differential on 05Mar2021 and was negative. The outcome of the events was recovered with sequelae on an unspecified date in Mar2021. Information about lot/batch number has been requested.
69 2021-04-06 pain in extremity, breast pain, weakness If she laid her arm on it, it was painful on the left side where she got the injection between her l... Read more
If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla; couldn't go back to sleep; very tired; weak; She had the lump and that was in the lymph node; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; irregular heart beats; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; baseball sized lump. It was hard/where she got the injection; It looked like it was connected to the breast because it was so huge.; Fever blister; heart beating so out of rhythm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 at 12:20 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing coeliac disease; hypothyroidism, is diabetic and has irregular heartbeat from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for hypothyroidism; hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN/HCTZ MYLAN) taken for blood pressure measurement; metformin, glipizide and pioglitazone hcl taken for diabetes mellitus; acetylsalicylic acid (ASPIRIN 81) taken for thrombosis; metoprolol taken for heart rate irregular, cyanocobalamin (VIT B12) taken for an unspecified indication, all from an unspecified start date and ongoing; famotidine, rosuvastatin, vitamin d2, vitamin d3 and potassium, all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6198, NDC: 59267-1000-1, expiry: unknown) on 27Feb2021 at 1:40PM for COVID-19 immunisation. The patient got her last shot on 18Mar2021. The first day was fine. She woke up the next morning at three or four with her heart beating so out of rhythm it was crazy. It took almost the whole day. She called her cardiologist and couldn't get into them and she didn't want to go to the ER. She didn't have a way to prove any of that. She also got a baseball sized lump. It was hard. If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla. It extended underneath the axilla. She wasn't able to get in with the cardiologist because she waited to late in the day. She couldn't get off the couch that day because her heart was so out of rhythm. She was very tired and wanted to just lay down. She hates going to the hospital. She doesn't want to go to the hospital. She has a history of irregular heartbeats. She should have gone in and had an EKG. She has pictures of the lump if those are needed. HCP information: Her doctor had said if she had anything like any abnormal heart beats to come in and get an EKG. She also had a fever blister on 22Mar2021 that she hasn't had in years and was asking if this influences her immune system. She had the lump and that was in the lymph node and now a fever blister on the top lip. Heart beating so out of rhythm: it lasted all that day. She took a nap after she talked to the doctor's office and slept for several hours. When she woke up it was kind of back in rhythm, but it was going in and out. It wasn't as frequent as it was prior to nap. Prior to the nap it was almost continuous. It slowed down a lot on the 19Mar2021 and was gone by 20Mar2021. Outcome of event: She has PAC's and PVC's anyway. That is why she follows up with the cardiologist. They haven't been so out of rhythm as they were after the vaccine. She couldn't go back to sleep. She still has them occasionally and that is kind of normal for her. She was weak and tired. Baseball sized lump: it has gone down. She took pictures to show her friends who were all getting the shots. It is gone now. It might have started on 20Mar2021. She woke up with the lump on Saturday. She has recovered completely. Her daughter said she needed to get it checked out. Reporter had heard of a lump on the breast was a side effect. It looked like it was connected to the breast because it was so huge. Seriousness criteria: It was irritating because it was so big. It was painful if she put her arm down. It was like her breast were engorged. Causality: Heart beating so out of rhythm: she hasn't had it that bad, so she thinks it was. She had it a long time ago, maybe once before, but it never lasted that long or took her down like that. She is not the only one that has had the complaint of irregular heartbeats. She put on social media what she experienced and how weak she got. Several friends said that happened to them as well. She doesn't know their history. Reporter declined to do a report on her friends. That was another reason she didn't go to the hospital. She thought it was a normal side effect. She thinks she found on her paperwork about the lump in the lymph nodes. The patient underwent lab tests and procedures which included electrocardiogram: unknown results and heart rate: irregular on an unspecified date. The outcome of the event fever blister was not recovered, while of the rest was unknown. Reporter seriousness for heart beating so out of rhythm was reported as disabling.; Sender's Comments: Based on the information currently available and the plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events 'heart beating so out of rhythm ', 'baseball sized lump (where she got the injection/It looked like it was connected to the breast because it was so huge)' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
69 2021-04-06 pain in extremity Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report... Read more
Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN9581), via an unspecified route of administration in left arm on 02Mar2021 13:30 (at the age of 69-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's first dose of bnt162b2 (lot not reported) (at the age of 68-years-old) in left arm on 01Feb2021 at 14:00 for Covid 19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have other vaccines within 4 weeks prior to the COVID vaccine. Medical history included mild syncope episodes and pacemaker. The patient had no allergies to medications, food, or other products. Concomitant medications included alondranate, calcium, metropolol and an unspecified multi vitamin. The patient experienced arm soreness in the first 24 hours on 02Mar2021. Mild syncope and low grade fever 20 days after dose 2 (on 21Mar2021 at 13:00). The treatment received for the adverse events was paracetamol (TYLENOL). The outcome of all events was recovered on 03Mar2021 for pain in extremity and in Mar2021 for the rest of the events.
69 2021-04-07 unresponsive to stimuli difficulty breathing, confusion, Unresponsiveness, pulmonary congestion.
69 2021-04-09 muscle spasms, pain in extremity Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg crampin... Read more
Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; the inside of her thighs were a little red on the side, both legs from her thighs to her knees; the shot is already fogging her mind; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 08:30 (Lot Number: ER8727; Expiration Date: 31Jul2021, at age of 69 years old) at a single dose for covid-19 immunization. Medical history included allergies: Penicillin, Ampicillin, hair color product. The patient's concomitant medications were not reported. She was allergic to Penicillin, and Ampicillin. As a child, always reacted strongly to any vaccination she was given with a fever and flu like symptoms for a couple of days. With Ampicillin, she thought she was having a heart attack. Was told to stop Ampicillin immediately because she could get a heart attack. This was when she was 25 years old and she never went to the ER. She was allergic to a hair color product in the 1990s and it made her scalp itch really badly. Was given a cortisone shot, which she reacted immediately breaking out head to toe in hives. Has no NDC/LOT/EXP for the vaccinations she reacted strongly to as a child. Stated this was in the 1950s or early 1960s. Clarified she did not have a heart attack with Ampicillin, but it felt like she was having one. Has had cardiograms per her request and her heart and heart walls are perfect. The patient received the first dose of the Covid vaccine at 8:30 a.m. this morning on 26Mar2021. Caller reports around 11 a.m., she experienced excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh, states that the pain lasted 15 minutes. The patient reports the same pain occurred on the opposite leg around noon and lasted for 15 minutes, states that "the pain was so excruciating that she could barely stand up and it was so agonizing it was unbelievable." The patient noticed that the inside of her thighs were a little red on the side, both legs from her thighs to her knees. The patient states that she has not been in the sun, and didn't think it was anything alarming, but this is abnormal for her, states that she received the vaccine in the right arm and her upper torso is fine and her head is clear, asked if anyone else had reported this reaction. She was planned to received the second dose on 16thApr in the early afternoon. The patient stated the COVID shot was already fogging her mind. The patient felt pretty good after first shot. Felt nothing. Fifteen minutes before leaving the diner she got a leg cramp. Was sitting in a booth and didn't think much of it. Attributed it to the way she was sitting. Around 11AM when she got back to her garage, she was in agony. It hurt from the top of her rear all the way down the side to the back of her knee and rolled to the inside of her thigh. She was in such agony and didn't know if she could get out of her chair and walk. By the time she reached her apartment it has subsided. An hour later, same thing happened in the left leg. She was laying in bed and texting because she didn't' know if she would get any other reaction. This leg cramp was even worse. She was in tears. Got off bed to try and walk it off. Initial leg cramp happened in right leg. Was excruciating. Both times it lasted for 15 minutes. Both cramps were from her buttocks, all down to her knees, and rolled over into her thigh. Didn't know if that was a reaction. It is not typical of anything written on Pfizer's information or that she had heard. She was concerned. Heard about blood clots, but not with this particular product. Stated second leg cramp subsided. If it hadn't, she wouldn't have gone to the ER. Leg cramps was so excruciating. Originally thought it was coincidental and stated she will be 70 on (Date withheld). To say she has never had leg cramps before would be a lie. The way the leg cramps were timed was kind of weird. It was absolutely the same kind of cramp and location just on the a different leg. Weight: Gained 25lbs. Doesn't have COVID or any symptoms. Tested three to four months ago and was negative. Received first dose COVID-19 Vaccine today, 26Mar2021, at 08:30AM. First leg cramp began 11:00AM in right leg. Second leg cramp began Noon in left leg. Each time lasted 15 minutes. Not having leg cramps right now. Could barely talk when having leg cramps. Was worried about getting clots in legs. Otherwise she would think it was because she was getting older. She doesn't get leg cramps very often. Doesn't know when the last time she had leg cramps prior to today. Nurse technician at vaccine faculty stated caller's allergy history wouldn't be a problem and she only had to sit for 15 minutes. Received the COVID-19 Vaccine and hardly felt it. Waited for 15 minutes. She was fine until 11AM. She was fine now, but her arm might get a little stiff tomorrow. Arm was slightly tender. Surprised she felt something in her legs. Doesn't know whether to associate it with COVID-19 Vaccine or not. Has nothing to complain about in the upper torso or from the waist up. Wants to know if this is a reaction or coincidence. Stated she expected to have a stiff arm. The outcome of the event "Cramps in legs" and "pain" was recovered on 26Mar2021. The outcome of other events was unknown.
69 2021-04-09 pain in extremity blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee d... Read more
blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; blood clot in the leg; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN3248, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 16Feb2021, 15:30 PM at a single dose for covid-19 immunisation (age at vaccination was 69 years). Medical history included blood pressure and thyroid. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine, valsartan, furosemide, acetaminophen. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 16Feb2021, 3 hours after the patient received the vaccination at 18:30 the patient's left leg from the knee down started to swell, got really hard and became very painful. She could hardly walk and afterwards the pain was so intense that she went to the doctor. Doctor took X-rays of her left leg on 16Feb2021, then he diagnosed her with blood clots. He gave the patient 2 heparin shots and immediately sent her to the hospital for a deep vein ultrasound on 16Feb2021. The results showed blood clot in the leg. The patient was prescribed medication and sent home. Her leg continued to be rock hard and painful. On 02Mar2021, the patient was sent for a blood panel work up. There was no improvement. On 08Mar2021, the doctor sent her for a lung CT scan. On the same evening, the patient was called to the doctor's office and was sent to ER immediately as the results showed blood clot in the lung. The patient's dose of Eliquis was doubled. This has now been going for 5 weeks, the patient had not been without pain during this time. Her left leg hardness had gone down a little but was still twice the size of her right leg, knee was huge. The swelling never goes down, not even at night. No covid prior vaccination and no covid tested post vaccination was reported. This case was reported as serious. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
69 2021-04-09 bell's palsy she got really tired; She started having problems on 12Mar2021 & went to the Emergency Room on 24Mar... Read more
she got really tired; She started having problems on 12Mar2021 & went to the Emergency Room on 24Mar2021 & was diagnosed with Bells Palsy; he had a severe headache, as well. She said the headache felt like major pressure and pain on the right side of her head, specifically behind her right ear; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Lot number - EN6206, expiry date- not reported) via an unspecified route of administration in right arm on 10Mar2021 at 12:00 PM as single dose for COVID-19 immunization. Medical history included ongoing type 1 diabetes mellitus Stated she has had Type 1 Diabetes Mellitus for about 50 years, sleep apnoea syndrome for years, thyroid disorder and influenza immunisation. Concomitant medication(s) included trazodone. On 12mar2021, the patient started having problems on 12mar2021 & went to the emergency room on 24mar2021 & was diagnosed with bells palsy and he had a severe headache. She said the headache felt like major pressure and pain on the right side of her head, specifically behind her right ear and she got really tired. The outcome of bells palsy is recovering whereas the outcome of headache and tired is recovered and unknown respectively. The patient underwent lab tests and procedures which included computerised tomogram: normal on 24Mar2021 and computerised tomogram head: normal on 24Mar2021. Therapeutic measures were taken with events. The patient took Prednisone and Venlafaxine for Bell's palsy and myalgia pain and trazodone taken for sleep apnoea syndrome. The other medication used for events were Valtrex, Tylenol and Acetaminophen.
69 2021-04-11 tremor Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like sy... Read more
Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like symptoms, including fatigue, muscular weakness and tremor, confusion, memory problems, lack of concentration. Abandonment of previously routine household and personal tasks. Inattentiveness to personal hygiene. Inability to perform previously routine tasks. Notable lack of concern about lost physical and mental capabilities.
69 2021-04-14 numbness, tingling Client complained of tingling/numb feeling in left arm from elbow to fingers 5 minutes after receivi... Read more
Client complained of tingling/numb feeling in left arm from elbow to fingers 5 minutes after receiving COVID vaccine. Hands and fingers warm to the touch, injection site clear. Observed and vital signs stable. Numbness and tingling resolved 45 min after start. Client home with instructions to follow up with primary care.
69 2021-04-14 muscle spasms Severe headache, long lasting cramps over entire night in both legs, and chills
69 2021-04-16 pain in extremity, feeling of body temperature change She was so dizzy; Stool black; Explosive bowel movements; hot and cold chills; hot and cold chills; ... Read more
She was so dizzy; Stool black; Explosive bowel movements; hot and cold chills; hot and cold chills; drenched in sweat; walker to back up in the bed; Nauseous; Sore arm; Slight headache; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: EM9810), on the morning of 16Feb2021 09:58 (at the age of 69-years-old) intramuscularly in the right arm as a single dose for COVID-19 immunization. The patient's medical history included knee replacement surgery years ago, dyslipidemia, depression, insomnia, constipation problems; she was taking clopidogrel (PLAVIX) because she had a hole in her heart last year (2020). This was fixed (on an unspecified date), and she was only taking PLAVIX once a day for one year, which will be until Jul2021; the patient called it a hole in her heart because that was what her heart specialist told her. Concomitant medications included: clopidogrel bisulfate (PLAVIX) taken for hole in heart from Aug2020 and ongoing, venlafaxine hydrochloride (EFEXOR), simvastatin (ZOCOR), and temazepam. The patient had an allergic reaction to sulfamethoxazole/ trimethoprim (BACTRIM), and she was also allergic to hydrocodone bitartrate/ paracetamol (VICODIN). On 17Feb2021, had a slight headache and a sore arm. On Friday, 19Feb2021, she woke up very nauseous to her stomach; no treatment received. The patient had hot and cold chills really bad. Her head was just drenched in sweat and this occurred all day long. When she did go to use the restroom and had a bowel movement, her stool was black. It was like black tar around 10:00 or 11pm, it was bad. Every time she sat down to use the bathroom, the sweating would get more intense and every time she would get up and use the restroom, she had to use a walker. Then, she used the walker to back up in the bed (19Feb2021), and she seemed to be okay. It seemed like the sweats would go away and she would get the cold chills. The patient just put a heating pad on her stomach, and this occurred all day long until Saturday morning. She mentions she does have constipation problems, but this was explosive. She couldn't get to the restroom a few times. She had several explosive bowel movements on 19Feb2021 10:00. Her husband brought the garbage pail in the bedroom and she did use plastic on the bedding. By 11:30-12pm on Saturday (20Feb2021), it completely stopped, but she was still sweating. She was so dizzy. It would hit her so bad and her head as wringing wet. However, when she would get back in the bed and lay down flat, the sweating would go away, and she would start to get the cold chills. The patient explained the sweating/hot and cold chills went away by yesterday afternoon (unspecified date). She was able to walk back and forth to the restroom with no problems. She verified all of her symptoms have improved. On 02Apr2021, the patient reported she received the second dose of the vaccine on 09Mar2021. The patient reported that sore arm and chills were important medical events, for which no treatment was received. Treatment received for diarrhea included "limgen". The outcome of explosive bowel movements and stool black was recovered on 20Feb2021, and the other events recovered on an unspecified date. Follow-up (02Apr2021): New information received from a contactable consumer includes: medical history, product data, concomitant medications, and event details. Case upgraded to serious. Follow-up attempts are completed. No further information is expected.
69 2021-04-17 pain in extremity heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; ... Read more
heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; This is a spontaneous report from a . A contactable consumer (reported for herself). The 69-year-old female patient received first dose BNT162B2 (Pfizer Covid-19 Vaccine Lot Number: EP7534 and Expiry date: Unknown) via an unspecified route of administration on left arm at a SINGLE DOSE on 18Mar2021, for COVID-19 immunization. Medical history and concomitant medication were not reported. On 18Mar2021 (the night she received the Pfizer Covid Vaccine, dose one) she woke with her heart pounding (heart palpitations), slight headache, muscle aches, and left arm hurt. When she went to the doctor, on an unspecified date in Mar2021, they took her blood pressure, and it was very high. It was stated that she went to primary care physician and then she was sent to a Cardiologist. On 26Mar2021, she underwent electrocardiogram and echocardiogram, results were normal for both the investigations. On the same day 26Mar2021, she also had Holter monitor test done (electrocardiogram ambulatory) however the results were pending. On 20Mar2021, the patient recovered from the events of slight headache, muscle aches, left arm hurt and high blood pressure, the outcome of the event of pounding heart was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
69 2021-04-20 weakness This 69 year old female received the Covid shot on 3/10/21 and went to the ED on 3/14/21 and... Read more
This 69 year old female received the Covid shot on 3/10/21 and went to the ED on 3/14/21 and was admitted on 3/14/21 with weakness, lack of appetite, malignant neoplasm of brain and lung and died on 4/18/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
69 2021-04-26 feeling hot shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a ... Read more
shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a cold; felt hot; she couldn't sleep,; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737, expiration date: 30Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left deltoid on 08Apr2021 10:30 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia. Patient stated she has had fibromyalgia for about 20 years. She said she had a fibromyalgia flare up with increased back pain, and had a Toradol 60mg intramuscular injection in her left hip on Tuesday, 06Apr2021. Concomitant medication included ketorolac tromethamine (TORADOL) for fibromyalgia from 06Apr2021. It was reported she had her first COVID-19 vaccine injection on Thursday 08Apr2021 at 10:30AM. She said that night (08Apr2021) she couldn't sleep and woke up at 3:00AM (09Apr2021) with shortness of breath, productive cough, and throat congestion. She said she had so much throat congestion, she could hardly talk. She clarified she felt like she woke up with a cold. She said she still had the productive cough, but her other symptoms went away by 8:30AM-9:00AM on 09Apr2021. She said she hadn't had a cold in 4 years. She said she read something on the internet that suggested her symptoms may be due to having the COVID-19 virus prior to getting the COVID-19 Vaccine. She said if she had the COVID-19 virus prior to getting her first COVID-19 Vaccine, she was totally asymptomatic. She said she wanted to know what she should do. Patient further reported she felt her shortness of breath was medically significant because she was mouth breathing. She clarified she felt hot during that time, and took her temperature, which was 97 degrees. She said she thought the fact she was hot was medically significant because she thought she may have a bad respiratory infection or something. The patient was not brought to the emergency room or physician's office in response to the events. The patient recovered from shortness of breath, felt hot, throat congestion on 09Apr2021; recovering from productive cough, and unknown outcome for the remaining events. The events were assessed as related with bnt162b2.
69 2021-04-27 pain in extremity blood clot; lymphadenopathy; unable to walk without a cane; her left leg swelled up dramatically; pa... Read more
blood clot; lymphadenopathy; unable to walk without a cane; her left leg swelled up dramatically; painful leg; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (at the age of 69-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient received Pfizer shot a few weeks before reporting. Within 3 hours her left leg (she was inoculated on the left side) swelled up dramatically - - it was painful. Subsequently - a doctor discovered numerous blood clots in that leg; then a blood clot in one of her lungs. She was being treated but the lymphadenopathy has not subsided in her leg and she was now unable to walk without a cane. Lymphadenopathy was not resolved; the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
70 2021-01-04 pain in extremity Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was ... Read more
Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself. A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: "don't know if it E or and F, looks like EH9899") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension. The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling "like I had COVID." She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.
70 2021-01-04 night sweats Pfizer-BioNTec COVID-19 vaccine Patient received vaccine on 12/22/2020 and on 12/29/20, she emailed ... Read more
Pfizer-BioNTec COVID-19 vaccine Patient received vaccine on 12/22/2020 and on 12/29/20, she emailed us saying that she was feeling sleepy, tired, was having night sweats, and had headaches. Her head felt like someone had put a heavy stone on it. She can still function.
70 2021-01-04 weakness sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had ... Read more
sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had the virus or bad flu; could not hardly open eyes/eyes were very heavy; could not hardly open eyes/eyes were very heavy; chills; tiredness; headache; muscle pain; weakness; Joint pain; Fever; Injection site swelling and redness; Injection site swelling and redness; injection site pain; Nausea; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left upper arm, on 21Dec2020 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (lasted 3 weeks), high blood pressure (family history in mother and father), lumpectomy, breast cancer, radiation treatment, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, fibroid tumors, fibroid tumors surgery, thyroid problem, bone density problem, and lower lobe left of lung piece cut out (not cancer). The patient previously received chemotherapy (MANUFACTURER UNKNOWN) for breast cancer, pethidine hydrochloride (DEMEROL) for post fibroid tumors surgery and experienced swollen hands and arms, influenza vaccine (MANUFACTURER UNKNOWN) in 2020 (usually gets swelling/red arm), and oxycodone hydrochloride;paracetamol (PERCOCET) and experienced feeling sick. Concomitant medications included unspecified medications for high blood pressure, thyroid problem, and bone density problem and unspecified nasal spray, water pill, and vitamins. The patient experienced could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, injection site swelling and redness, injection site pain, nausea, sweats, and feeling of unwellness like she had the virus or bad flu on 22Dec2020. The clinical course was reported as follows: The patient felt fine the day when injection was given, but the next day, it was like she had COVID again. She had COVID 3 months ago and it lasted for 3 weeks. It was the same symptoms she had. She could not open her eyes hardly. They were very heavy. The patient had the chills, temperature, sweats, and injection site pain (the next day). There was also swelling and redness that remained for 6 days. The patient reported that if she still puts her hand on it now, there is some sensitivity. She also had tiredness and headache. The patient reported that she only had each of these symptoms for 24 hours (as reported) and the headache was gradually improved. The patient had muscle pain and weakness. She laid down and all she could do was sleep for 24 hours. The patient had nausea for 4 days. She did not have swollen lymph nodes. The patient underwent lab tests and procedures which included blood pressure: 120/80 on an unspecified date and bone density: unknown results on an unspecified date. The clinical outcome of could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, sweats, and feeling of unwellness like she had the virus or bad flu was recovered on an unspecified date, nausea was recovered on 26Dec2020, and injection site swelling and redness and injection site pain was recovered on 28Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
70 2021-01-05 tremor severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash ... Read more
severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash to face and throat,
70 2021-01-06 weakness, discomfort Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pf... Read more
Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pfizer-BioNTech. Administered by her place of work. Vaccine was administered in left arm. Had same symptoms as when she had COVID in 10/2020 these symptoms lasted for 12 hours. Started the following day 24 hours after vaccine administration. Symptoms include injection site redness for 6 days, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and overall feeling of un wellness lasting 12 hours. First symptoms was eyelid heaviness and weakness. No treatment, symptoms resolved on their own. Second vaccine due 1/11/2021. Was covid positive 10/2020- no appetite, aches, chills, sweating, weakness, heavy eyelids, fatigue, ongoing for 3 weeks. Has had difficulty in the past to flu vaccines with local injection site reactions. 09/2020 flu vaccine no symptoms. Has had pneumonia vaccine with no difficulties. Has not received shines vaccine yet.
70 2021-01-07 pain in extremity Had my 2nd vaccine on Jan 7, 2021. My arm was sore when I went to bed that night. I woke at 5:15 AM ... Read more
Had my 2nd vaccine on Jan 7, 2021. My arm was sore when I went to bed that night. I woke at 5:15 AM feeling achy. I took my temp and it was 98.8F which is a temp for me since I run low, around 96.9F I got ready for work at the hospital and went in. around 0830 my temp was 99.5 and I was more achy and sore. I called Employee Health and they said to continue to monitor my temp and call back if it passes 100. Then around 3PM , my temp was 101.5F I remain very achy and have some occasional ear pain and a mild headache,
70 2021-01-08 flushing patient feeling flushed & light headed. Onset occurred about 10 mins after vac Vitals monitored; no ... Read more
patient feeling flushed & light headed. Onset occurred about 10 mins after vac Vitals monitored; no swelling throat/face. After calming patient, symptoms subsided. Called Dr. for release/review. 71 y/o female who presents with facial flushing & light headedness that began after her vaccination. No progression or other symptoms. Hx of similar RXN after exercise symptoms. P.E - Mild facial flushing started Possible mild allergic rxn. Plan - home with monitoring.
70 2021-01-11 facial paralysis, numbness Facial paralysis; This is a spontaneous report from a contactable Pharmacist. A 70-year-old female... Read more
Facial paralysis; This is a spontaneous report from a contactable Pharmacist. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899, Expiration Date 30Mar2021), via intramuscular, on 17Dec2020 (at 15:35), at single dose of 0.3 mL for COVID-19 immunisation. The patient was vaccinated at hospital, age at vaccination was 70-year-old. Vaccine location was deltoid but unsure which deltoid. The patient did not have a relevant medical history and concomitant medications. Pharmacist said that after vaccination, she waited to be monitored the standard 15 minutes at hospital and then when she got in the car and was on the way home like 20 minutes later she had brief episode of what the patient described as facial paralysis. It was like the side of her face in one area felt funny, it felt numb and it was not anywhere else on her face. It lasted the 20 minutes and then went away. The patient had recovered from the events on 17Dec2020. The pharmacist queried if the patient can proceed with the 2nd dose of the vaccine. The reporting pharmacist considered the event 'facial paralysis' as non-serious.; Sender's Comments: A possible causal relationship between acute onset of facial paralysis and BNT162B2 cannot be completely ruled out considering the temporal relationship and the known adverse event profile of the suspect vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
70 2021-01-11 numbness, tingling Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and... Read more
Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and felt jittery, lightheaded, sweating, numbness/tingling in both hands, feeling strange
70 2021-01-11 numbness, tingling sweating, lightheaded, tingling/numbness in both hands, high blood pressure, swollen arm/redness
70 2021-01-12 numbness, tingling patient experienced numbness, and tingling in both hands. Stated that is was similar to carpel tunn... Read more
patient experienced numbness, and tingling in both hands. Stated that is was similar to carpel tunnel syndrome
70 2021-01-14 numbness Numbness in throat and arm, bp 137/87, 100% oxygen heart rate 72.
70 2021-01-17 flushing Patient received COVID pfizer vaccine at 0801PM. Patient left after 20 minutes after observation. Pa... Read more
Patient received COVID pfizer vaccine at 0801PM. Patient left after 20 minutes after observation. Patient was travelling with husband at the car when she experienced warm/hot cheeks, flushing and concerned with history of previous reaction. When patient arrived ( approximately 835pm), patient sat down on the chair. The redness started to extend to her neck and it was then decided to place the patient to the stretcher. Vitals signs were done in which the BP was 183/104 and 174/101 (845pm). The redness spreaded to her forehead and neck. Benadryl 50mg PO was then given (847pm). Patient BP was taken again which was 182/122 , pulse 80, RR 24 (855pm). Patient then complained about pressure in her throat, eyes (right eyes slightly swollen ) and face. It was then decided that epinephrine (859PM) be used but unfortunately the trainer box was removed so the epinephrine was not actually given. The BP documented was then 193/112 (0859PM). EMS was then called as the epinephrine was administered per protocol. EMS arrived (0910 PM) and BP at that time was 230/112, pulse 70. Patient was started with heart monitor and IV. EMS then took her to the Emergency across the street with husband.
70 2021-01-19 tingling l ARM TINGLING
70 2021-01-19 pain in extremity sore right arm, took Motrin
70 2021-01-20 feeling of body temperature change, weakness I had COVID-19 in December for more than 3 weeks. I felt like I felt during that time.. I was weak... Read more
I had COVID-19 in December for more than 3 weeks. I felt like I felt during that time.. I was weak. I hurt everywhere. I had a temperature. of 101-102 degrees. My normal temperature is 97.6. I had a severe headache. My vision was impaired. I would go from freezing to being very hot.
70 2021-01-20 tingling, numbness Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomi... Read more
Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomit; Both hands went numb with pins and needles; Both hands went numb with pins and needles; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration from 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included known allergies: latex, high blood pressure, hypothyroidism, and mitral valve prolapse. There were no concomitant medications. At 11am, 2 hours after receiving the first COVID19 vaccine, my reactions occurred simultaneously. The patient experienced Strong chills, Bad headache, Abdominal Very painful abdominal cramping, Heavy salivating, Nausea, Both hands went numb with pins and needles, the patient felt like she was either going to vomit or have a bowel movement, ultimately it was the latter. This is when both her hands went numb. These reactions lasted 15-20 minutes and then dissipated with the exception of a lingering less painful headache through Friday and Saturday. The patient did not receive treatment for the events. The outcome of the events was recovered.
70 2021-01-21 feeling hot, flushing Flushed hot face and neck, blood pressure 265/117
70 2021-01-24 tenderness 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, r... Read more
3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; his arm remains very tender to touch; Lost sleep due to pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EJ1686, expiry date unknown) intramuscular at the left arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 prior to vaccination; HTN, High cholesterol, and Asthma, all from an unknown date. The patient is not pregnant. Concomitant medications included ASA, carvedilol, ferrous sulfate, losartan potassium, magnesium, rosuvastatin, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D, pantoprazole sodium sesquihydrate (PROTONIX), budesonide, and formoterol fumarate (SYMBICORT). The patient had previous allergies with Zocor, Prolia, Evista, Daypro, Amlodipine, and Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021, 12:00 PM, the patient experienced 3in x 3in lump at the injection site, red in color and hot to touch. She lost sleep due to pain, his arm remains very tender to touch. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site mass, vaccination site erythema, vaccination site warmth and vaccination site pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
70 2021-01-24 weakness, feeling of body temperature change She feels a little bit of chills and weakness; She feels a little bit of chills and weakness; Cold a... Read more
She feels a little bit of chills and weakness; She feels a little bit of chills and weakness; Cold and hot feeling on [her] body; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced delayed symptoms after the first injection of the COVID-19 vaccine, received on 06Jan2021. Patient explained feeling fine the first three days post injection, and later on 09Jan2021 having "chills" and weakness. She then described her experience as "cold and hot feeling on her body". She felt good, her breathing was okay. Her oxygen and everything was okay. Outcome of the events was unknown. Information on the lot/batch number has been requested.
70 2021-01-25 weakness Patient self-reporting through the hospital's electronic reporting system. In her own words, "Recei... Read more
Patient self-reporting through the hospital's electronic reporting system. In her own words, "Received 2nd Pfizer COVID-19 Vaccine. Beginning 17 hours later, I had extreme weakness, headache, chills and fever. I had to take off Friday, January 22, 2021, from work because of not feeling well. I still am not feeling well".
70 2021-01-25 pain in extremity entire body felt sore; Her soreness/aching is mainly in her back, arms left deltoid, and legs; Her s... Read more
entire body felt sore; Her soreness/aching is mainly in her back, arms left deltoid, and legs; Her soreness/aching is mainly in her back, arms left deltoid, and legs/sore arm from the injection; Her soreness/aching is mainly in her back, arms left deltoid, and legs; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure, ongoing eye disorder, high cholesterol, and overweight. Concomitant medications included amlodipine, losartan, and metoprolol all from 2003 and ongoing for high blood pressure; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) for the eyes; and medication for high cholesterol. At night of 11Jan2021, the patient's entire body felt sore. Her soreness/aching is mainly in her back, arms left deltoid, and legs. She had a sore arm from the injection which started immediately. Outcome of the "entire body felt sore" and "soreness/aching in her arms left deltoid/sore arm from the injection" was not recovered while of the remaining events was unknown.
70 2021-01-27 pain in extremity Red spot where I had the vaccine and it was itchy; Red spot where I had the vaccine and it was itchy... Read more
Red spot where I had the vaccine and it was itchy; Red spot where I had the vaccine and it was itchy; it still hurts and when I touch it; Pain on my arm; Rash; I do feel like a little bit of a bump; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing thyroid disorder (Verbatim: Don't have a thyroid). Concomitant medication included ongoing levothyroxine for thyroid disorder. The patient stated on 16Jan2021, "I had the COVID Vaccine on the 14th (14Jan2021). I had just pain on my arm, no side effects. But today I noticed that I had a red spot where I had the vaccine and it was itchy, so I had, but it is mild. It is nothing that's all over me, I have got a rash or anything. Just on the side it looks little red and itches and it still hurts and when I touch it, I do feel like a little bit of a bump, little bit. Is this an allergic reaction and therefore for my second dosage, will that be may not react or what?" Clinical outcome of the events was unknown.
70 2021-01-28 pain in extremity Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontan... Read more
Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient receive first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EK9231), via an unspecified route of administration injection once to left upper arm in inner muscle on 10Jan2021 at single dose for covid-19 immunization. The patient had no relevant medical history and concomitant medications. The patient experienced fatigue/ extremely tired in Jan2021, dizziness/ very dizzy on 14Jan2021 18:30, pain on her arms in Jan2021. Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Sunday and has been experiencing some side effects. These side effects include Dizziness, Extreme fatigue and Pain on her arms. She wants to know if this was normal. She got her shot, later clarified as COVID shot, at hospital last Sunday, so about a week ago, and had no side effects up until yesterday, she was extremely tired, and last night about 6:30PM, she was very dizzy until 5 this morning. She works at a hospital; they gave the shot. Outcome of extremely tired: stated she was in bed, was just very lethargic, being very dizzy went away at 5 this morning, states she has recovered completely but she is just a little off. When asked for vaccination card, states she shouldn't have gotten up that fast, this was really weird that it would wait 5 days. This was her first shot, thinks the dose was on the paper, it was 0.3mg, she was not sure. The outcome of events for dizziness/ very dizzy was resolved on 15Jan2021, for fatigue/ extremely tired was resolving, for other events was unknown.
70 2021-01-28 tingling Reports feeling tingling on her fingers, both hands. She was evaluated by Fire department and relea... Read more
Reports feeling tingling on her fingers, both hands. She was evaluated by Fire department and released home feeling better at 2:10 pm.
70 2021-01-29 weakness Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone ... Read more
Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone floor and was unconscious. Taken to ER in ambulance. All diagnostics were normal and after blood pressure returned to normal and getting 4 staples in my scalp I was released. Since coming home I have been very ill with weakness, vertigo, nausea, and headache.
70 2021-01-29 feeling hot Patient describes having lips tingling, and feeling hot as well as her upper gums occurring about 7-... Read more
Patient describes having lips tingling, and feeling hot as well as her upper gums occurring about 7-8 minutes after the vaccine administration. Patient denies any difficulty in breathing. Patient is drinking some juice- describes the feeling of her throat feeling scratchy. 1035 VS- HR-52, 96% RA, 132/76. At 1048 patient reports that she feels better and the symptoms have gone away and she feels the same as she did when she came into have her vaccine. Patient will continue to wait a full 30 minutes after beginning of being checked out. 1100- patient reports again feeling the same as she did when she walked in and feels ok to leave.
70 2021-01-31 weakness Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling ... Read more
Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling well. Pt complained of lightheaded/dizziness, headache, and weakness and transferred to wheelchair. Vital signs monitored (148/77, spo2 100%). Patient stated this is above her baseline and not usual. Patient began to complain of chest pressure and was transferred to EMS stretcher to continue to monitor and transferred to hospital.
70 2021-01-31 one side paralysis Resident was noted on 1/25 with an increased functional decline as she would not feed herself with u... Read more
Resident was noted on 1/25 with an increased functional decline as she would not feed herself with utensils, but would eat finger foods if placed in her hand. She was started on Rocephin IM for possible infections. Labs had been obtained on 1/21/21, unremarkable for CBC and CMP. 75,000 colony count on urine. On 1/26/21 she was noted with right sided weakness and further decline. She was sent to Hospital for further evaluation. We were notified that she expired on 1/28/2021. Resident had been noted with a decline in function about 2 weeks earlier when she would not stand or transfer any longer. She was still responsive, taking meds, and feeding herself until 1/26/21. Further information on admitting diagnoses and progress notes from hospital have not been available to date.
70 2021-02-01 tingling, numbness Bad taste in mouth; numbness and tingling on right side of face; numbness and tingling on right side... Read more
Bad taste in mouth; numbness and tingling on right side of face; numbness and tingling on right side of face; swollen area near jaw line; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (pregnant: No) received first dose of bnt162b2, via an unspecified route of administration in right arm on 19Jan2021 11:00 at single dose for covid-19 immunization. Medical history included cardiac patient, iodine allergy from an unknown date and unknown if ongoing. Concomitant medication included prednisone, clopidogrel bisulfate (PLAVIX), lisinopril. The patient experienced bad taste in mouth, numbness and tingling on right side of face, swollen area near jaw line on 19Jan2021 with outcome of recovering. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No other vaccine in four weeks. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch has been requested.
70 2021-02-01 pain in extremity Yesterday and still today it felt like I burnt the tip of my tongue; poking my tongue with needles, ... Read more
Yesterday and still today it felt like I burnt the tip of my tongue; poking my tongue with needles, very painful; My tongue was numb for 2-3 hours; Arm hurt; This is a spontaneous report from a contactable consumer (patient). A 70-year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at 10:21 at single dose in left arm for COVID-19 immunisation at the age of 70-year-old. Lot number was EL1284. Medical history included blood pressure, COVID-19 in Mar2020, loss of smell and taste in Mar2020, diarrhea in Mar2020, ongoing headache since Mar2020 (started with eyes, thought the patient had pink eye, she had a headache right at the time of report), chills in Mar2020. Concomitant medications included ongoing olmesartan for blood pressure. The patient received flu vaccine in Oct2020. The patient received her vaccine on 15Jan2021; she was informed to wait 15 minutes after getting the vaccine and she did. When she left the park about 2-3 minutes after waiting the 15-minute observation period she started to feel a sharp needle poking type feeling on her tongue, it was painful. Her daughter asked if she wanted to turn back around, but they did not. The feeling did not last long. She then added, later that day it felt like the tip of her tongue was numb. It stayed that way for at least 2 hours and then went away. On 17Jan2021, she woke up and she has the feeling on her tongue as if she drunk something hot and burnt the tip of his tongue. She has this burnt feeling sensation on her tongue and she had not eaten or drunk anything yet. Poking sensation on tip of tongue that was painful occurred like 17 minutes after she got the injection. It is like her tongue was being poked with needles. She later had numbness on her tongue, this lasted like 2 hours. It seemed like a numbing solution was administered with the vaccine. The way her tongue felt, it was as if there was a numbing solution in the needle with the vaccine. Her tongue was very numb for a while, but it then went away. On 17Jan2021, she started to feel the tip of her tongue was burnt. She looked at her tongue on 17Jan2021 and it was red. She has not looked at it the day of report so she did not know what it looked like. The patient initially stated, besides the tongue issue, she had no issues. However, she then later stated and clarified the only other issue she had was her arm hurt a little; it was not bad, but it did hurt; it did not hurt at the time of report, it started the same day she got the vaccine during the night. The patient recovered from Poking sensation on tip of tongue that was painful, Tongue numb on 15Jan2021, patient was recovering from Tip of tongue feels like it was burned, the outcome of arm pain was unknown.
70 2021-02-03 pain in extremity arm has been sore; looked like she had a sunburn all over her body/sunburn looking skin felt like he... Read more
arm has been sore; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccination site: left, almost her shoulder) on 14Jan2021 13:45 as COVID vaccine. The vaccine was administered at clinic. Vaccine not administered at military facility. There were no concomitant medications. Patient had no prior Vaccinations (within 4 weeks). The patient previously took acetylsalicylic acid (ASPIRIN), ibuprofen and NSAIDS wherein she was allergic. This was years and years ago. When she took the products, she had silver dollar size hives from head to toe. Patient asked if there was any of this in the vaccine. The patient previously got shingles vaccine on 2019 (2 years ago) at the pharmacy wherein she had a sore arm and a bruise. The patient had no other relevant history. Patient reported she just got home from the emergency room. It was explained that on 14Jan2021 (yesterday) she got the vaccine. On 15Jan2021, her arm had been sore today since getting up but about 1pm today she looked like she had a sunburn all over her body. Her husband gave her 2 diphenhydramine (BENADRYL) and rushed her to the emergency room. They told her that they can't say for sure but that was likely that it was caused by the vaccine. The soreness was about the same. Looking like she had a sunburn all over her body, that was gone. The patient further explained the sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on. There have been no other treatments. She remarks she had to wait so long in the emergency room by the time they saw her it had resolved. Investigation assessment/relevant tests were not performed. The emergency room told her the Benadryl likely knocked it out. They offered Tylenol and an IV but she declined; she felt there was no reason since she was doing better. She was told to take 2 more diphenhydramine 25mg in 6 hours. No physician office visit required for the events. She was supposed to get the second dose on 04Feb2021 but was told to ask if she should still get it. The outcome of arm has been sore was not recovered, while other events recovered on 15Jan2021. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
70 2021-02-03 burning sensation, speech disorder bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl a... Read more
bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything; threw up; very dizzy/dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, unknown expiration), via injection in right arm on 13Jan2021 at a single dose for COVID-19 prevention. Medical history included ongoing vertigo (in car accident a little over 5 years ago, that affected a big nerve in left temple, and so every once in a while she will get vertigo so bad that she falls over), ongoing GERD (from a hiatal hernia; diagnosed many years ago), ongoing high blood pressure diagnosed about 15 years ago, ongoing bad cholesterol diagnosed 10 to 15 years ago, ongoing heart burn, ongoing hiatus hernia, and car accident a little over 5 years ago. Concomitant medications included ongoing omeprazole sodium (OMEPRAZOLE) for GERD, heart burn, and hiatal hernia (started this product at least 10 years ago; takes the product as needed if she is having heart burn or is going to eat spicy food); ongoing vitamin D3 for vitamin supplementation (started product about 8 months ago, because her doctor told her too, she guesses her vitamin was low); ongoing metoprolol for high blood pressure and to prevent stroke (started product at least 15 years ago; her BP could be regular but it could shoot up when she is upset, so she takes this to prevent stroke); ongoing hydrochlorothiazide for blood pressure (started product at least 5 years ago); pravastatin for bad cholesterol (started the product at least 4 or 5 or more years ago); and ongoing acetylsalicylic acid (BABY ASPIRIN) to prevent stroke (has been taking this product forever, at least for 10 years). The patient reported that she received the first COVID shot on 13Jan2021. She was okay on the 13th, 14th, and 15th. However, on the 16th (16Jan2021), she woke up and threw up once and was very dizzy for three days. She mentioned that she had like vertigo, she couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything. She had vertigo (16Jan2021). She was that way on Saturday and Sunday. On Monday, the patient's son took her to acupuncturist for her dizziness and was able to get up fine and walked away. After the acupuncture, she felt fine, like she was all better. On 19Jan2021 (reported as yesterday), she was fine. She woke up at midnight and had terrible acid reflux for 3 hours even though she had hardly eaten. She does take omeprazole for heart burn, and she had taken omeprazole earlier in the day, but it was just coming up, that acid and burning. She drank milk to coat the stomach and it went away at 03:00 AM. She had very bad chills/terrible chills (20Jan2021) and her teeth were chattering, she couldn't even talk, and couldn't control the chills. She is fine now. She clarified that she got vertigo from a car crash years ago and haven't had it in almost a year. Chills are not ongoing at this time, she has not had any for about 4 hours now, and she is hoping she is recovered completely, but it may be too soon to tell. She did not receive other vaccines on the same day as the COVID vaccine. The patient is wondering if all this could be from the vaccine. The patient wanted to know if it is safe to take the second shot. She was scheduled to receive the second dose on 03Feb2021. The patient recovered from the events threw up on 16Jan2021; unable to walk and vertigo on 18Jan2021; dizziness on 19Jan2021; and terrible acid reflux on 20Jan2021. While unknown outcome for chills.
70 2021-02-03 burning sensation, tingling feels itchy; burning; tingling and paresthesia all over her body; This is a spontaneous report from ... Read more
feels itchy; burning; tingling and paresthesia all over her body; This is a spontaneous report from a contactable physician. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 12Jan2021, and she has had a serious reaction since; she felt itchy, burning, tingling and paresthesia all over her body. She has been on Benadryl for it. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events itchy, burning sensation, paresthesia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
70 2021-02-04 weakness Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakn... Read more
Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakness, diarrhea . Had Weakness for two more days.
70 2021-02-04 tingling c/o tingling starting 1 hour ago on left side of her face. She received a Pfizer COVID 19 vaccine, w... Read more
c/o tingling starting 1 hour ago on left side of her face. She received a Pfizer COVID 19 vaccine, was watched for 15 minutes, went home in stable condition. Later noted a tingling sensation in her left side of the face and throat, she denies any other weakness, no difficulty speaking or walking.
70 2021-02-05 pain in extremity My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening,... Read more
My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening, but symptoms continued and migrated from there. The arm remained sore for 3 days and then began to itch. This itchiness continued on and off for the next 2 days. My neck and shoulder were also sore. The shoulder continued to be sore for about 4 days. I had an intermittent headache, also for 4 days. The worst part though, is the nausea, which also comes and goes. But it can last for many hours and now, even after 8 days, I am still experiencing this. I can find nothing in the writings about this vaccine to corroborate this side effect and I am therefore worried about the second shot.
70 2021-02-05 flushing Severe headache, face flushing, swollen tongue, throat closing off
70 2021-02-05 feeling cold, feeling hot, tremor Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By ... Read more
Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By 3am, had fever, chills, couldn't stop shaking or get warm, had headache, skin sensitive almost hurt when touched. Felt too bad to get out of bed but eventually got up, took acetimetophen, drank water, added clothes and blankets and returned to bed. Body kept tensing up very tightly so that all muscles were constricted/tights and impossible to relax. This continued for a few hours. By morning, I thought I was starting to feel better. These symptoms returns for a second round about 2pm that afternoon and continued until about 6pm. On the nights of 2/3, 2/4 and 2/5, I wake up around 3am extremely hot and sometimes damp, despite air temp of 66 to 68 degrees. This resolves after about an hour and body feels normal.
70 2021-02-06 pain in extremity Severe myalgia, chills, fever - flu like symptoms, fatigue, dizziness, joint pain and bilateral met... Read more
Severe myalgia, chills, fever - flu like symptoms, fatigue, dizziness, joint pain and bilateral meta-tarsal pain on hands (which I used to have as part of my osteopenia. But was symptomless for a while). After about 18 to 20 hours after vaccination experienced severe bilateral metatarsal pain and joint pain on knees and back. Mild to moderate nasal congestion. Took 1 gram APAP /Benadryl alternating with ASA 325mg along with bedrest. Over the course of 2 days the pain (myalgia and arthralgia), flu-like symptoms and congestion resolved.
70 2021-02-06 feeling hot after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling ... Read more
after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling numb and tingly, was taken to ER as it was part of the same building in a wheel chair, was also anxious, nauseated and had dry heaves and blood pressure was elevated. Received IV solumedrol, ativan and zofran and then later oral benadryl. I was told to contact my PCP to see if I should get the second vaccine and he indicated no.
70 2021-02-08 bell's palsy On 2/6/2021 woke with neck pain and droopy eyelid on the left side of the face. Went to the ER and w... Read more
On 2/6/2021 woke with neck pain and droopy eyelid on the left side of the face. Went to the ER and was diagnosed with Bell's Palsy.
70 2021-02-09 tremor, pain in extremity Sore arm; lost a bunch when she had sugery; Tremors in her hands/hands started shaking non-stop; Tre... Read more
Sore arm; lost a bunch when she had sugery; Tremors in her hands/hands started shaking non-stop; Tremors in her hands/hands started shaking non-stop; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 21Jan2021 at 10:40 at single dose for COVID-19 immunization. The relevant medical history included asthma, tremor (Tremors that runs on her mother's side of the family), neuropathy of hands and arms, high cholesterol, thyroid, neuropathy, vascular gait disorder, cervical stenosis operation from 2018. Concomitant medications included painkiller for neuropathy and unspecified medicines for high cholesterol, thyroid. She stated she received the first dose on 21Jan2021 and experienced tremors in her hands starting the following day. She stated that Friday her hands started shaking non-stop and had done that since then. She also reported having a sore arm. She had occasional tremors that didn't last very long. Since COVID-19 Vaccine had had nonstop shaking of hands since around Friday. Primary care doctor didn't treat her. Went to a pain center and neurologist. No further details provided. Tried to report online, but there were too many questions so she opted out. Does kind of get better if she is real still and lays down, but it still shakes. Never had this before. The patient stated that Friday or Saturday she didn't remember exactly when, sometimes they shake but not very long but this was like nonstop and it's a much more aggressive shaking. She hoped she could get the second one because she wanted the protection. She was not sure of her weight because she lost a bunch when she had surgery but she was about 115. When probed for treatment, she stated that it went away it was a day or so after but the hands were shaking and it's very intense shaking and it's going on and it's not stopping. She didn't have anything for it. It's never been like this before. The outcome of the event tremors in her hands/hands started shaking non-stop was not recovered, while other events were unknown. Information about lot/batch number has been requested.
70 2021-02-09 weakness face looks a little bit swollen; super tired; light dry cough /Light coughing; feeling like weaknes... Read more
face looks a little bit swollen; super tired; light dry cough /Light coughing; feeling like weakness; bone pain; muscle ache; She had some prior ache before but today it was stronger; This is a spontaneous report from a contactable consumer (daughter). A 70-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ8982 and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, blood pressure high, had Corona virus before in Nov2020, and ongoing ache. The concomitant medication was reported as Lisinopril at 10 mg, one tablet a day for Blood pressure high and Vitamins. Patient woke up this morning (23Jan2021) super tired, light dry cough and face looks a little bit swollen. No just tired, she was feeling like weakness, a lot bone pain or muscle ache like a lot. The patient had some prior ache before but today it was stronger. She still feels some pain. Treatment for bone pain or muscle ache, pain was Ibuprofen. The reporter wanted to know if these symptoms are common reactions to the vaccine; if the COVID-19 vaccine can give a COVID-19 infection; if patient should receive the second dose of the COVID-19 vaccine since she was having these side effects. The outcome of events, bone pain or muscle ache, pain was not recovered. The outcome of other events were unknown. No follow-up attempts are possible. No further information is expected.
70 2021-02-09 migraine light sensivity. Light hurts my eyes almost like migraine; migraine; This is a spontaneous report fr... Read more
light sensivity. Light hurts my eyes almost like migraine; migraine; This is a spontaneous report from a contactable consumer reported that a 70-year-old female patient (consumer) (non-pregnant) received BNT162B2 (Solution for injection, lot number: El3249) on 27Jan2021 at 11: 00 AM in single dose for Left arm, dose number: 2, for covid-19 immunization. Patient medical history included Controlled BP, cholesterol, thyroid, known allergies: sulfa drugs. Patient previously took cimetidine sodium alginate (TAGAMET) and had Tagamet allergy, tetracycline and had tetracycline allergy, Iodine and had Iodine allergy. Historical vaccine included BNT162B2 on 06Jan2021 at 11:00AM (lot number=EK9231, vaccine location=Left arm, dose number=1) for covid-19 immunization. Concomitant medications were not reported. On 28Jan2021, at 08:00AM, patient had light sensitivity and Light hurts my eyes almost like migraine. If this was still like this Monday she will go to doctor. No treatment was received for adverse event. It was unknown, whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was not recovered.
70 2021-02-11 tremor, feeling hot, facial paralysis blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumpin... Read more
blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; facial muscles became weak on both; difficult to make facial expressions; my mouth began to tremble; chills; facial muscles became weak on both; difficult to make facial expressions; This is a spontaneous report from contactable consumers. An 70-year-old female non-pregnant patient received her first dose bnt162b2 (BNT162B2; Solution for injection; lot number: EL9283) via an unspecified route of administration at Left arm on 28Jan2021 12:30 at single dose for COVID-19 immunisation at Clinic. Medical history included high blood pressure, high cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR), amlodipine, calcium carbonate simethicone. There was no other vaccines in four weeks. The patient previously took iodine had contrast, procaine hydrochloride (NOVOCAIN) had drug allergy, omeprazole (PRILOSEC) and had drug allergy, olmesartan medoxomil (BENICAR) had drug allergy. Five minutes after the injection 28Jan2021 12:35, patient felt blood pumping to her head and became very hot. Her face turned red and was hot to the touch. Then, facial muscles became weak on both sides and made it difficult to make facial expressions. Lastly, her mouth began to tremble and had chills. Symptoms subsided about 30 minutes after the injection. she worried about getting the second injection. The patient received treatment with Liquids/electrolytes. The events result in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in 2021.
70 2021-02-16 tingling, cold sweat 01/27/2021 at 1514 Particpant c/o of fast heart beat, possible difficulty breathing and hand tinglin... Read more
01/27/2021 at 1514 Particpant c/o of fast heart beat, possible difficulty breathing and hand tingling. Assessed & noted p - 109, O2 sat 97%, skin warm / clammy with no discoloration at left upper arm injection site. Allergies verified and noted as Sulfur, Levaquin and PCN. Participant remained sitting and encouraged to deep breathe. At 1518 B/P 153/100, HR 102, O2 sat 98% with continued c/o. EMS activated at 1518 and pt moved to monitoring area; declined lying down, sat in chair for care. Post move to chair O2 sat drop to 90% then returned to 96%, HR 111. 1522 Administered Benadryl 50 mg IM right upper arm with no resp distress / rash noted. At 1554 participant voiced feeling better already with arrival of EMS noted
70 2021-02-16 breast pain Soreness and tenderness in breast.
70 2021-02-17 flushing Nausea, flushed, dizzy, after about 20 minutes my throat closed, unable to breath. The workers did ... Read more
Nausea, flushed, dizzy, after about 20 minutes my throat closed, unable to breath. The workers did not know how to use epi-pen. I used my own epi- pen, ENT used heart monitor, intervenious Benadryl was administered, I was transport to ER at hospital, treatment with more meds, prednisone. I was kept in ER for several hours for monitoring. I had no more reaction.Y
70 2021-02-18 feeling hot Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in... Read more
Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
70 2021-02-21 migraine 27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature wen... Read more
27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature went up to 100.8. My chest was tight and achy and my oxygen levels stayed at about 88. I slept about 10 hours and woke up feeling fine. My chest is sore and achy but better than yesterday.
70 2021-02-21 pain in extremity Dizziness that is continuing, fatigue, arm soreness, swelling of lymph nodes
70 2021-02-21 weakness Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took ace... Read more
Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took acetaminophen and some anti -nausea drugs I had on hand. Fever left, but returned next night. Weakness, no appetite stayed for two days. Thought it was the flu, but no upper respiratory symptoms. Thought it might be Covid-19 but tested negative. Finally decided it was a reaction to the vaccine.
70 2021-02-22 unresponsive to stimuli, discomfort, feeling cold, cold extremities 2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-g... Read more
2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.
70 2021-02-22 tenderness, pain in extremity A small reddish bump on my arm at the injection site, my arm is sore any tender to the touch. The bu... Read more
A small reddish bump on my arm at the injection site, my arm is sore any tender to the touch. The bump is getting larger in size.
70 2021-02-22 feeling hot I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. ... Read more
I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. There was a sense of nausea initially but it went away. There was pronounced feeling of heat located subcutaneously on my right outer thigh. It came and went about every minute or so. (I counted the seconds in between each incident). I am still experiencing flu like symptoms (bodily aches, slight headache, mild chest pain, and general ill-feeling.) I will contact my primary care physician today about my concerns but felt it necessary to document these mild but disturbing side effects.
70 2021-02-22 burning sensation, feeling hot Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started... Read more
Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started on left arm, moved to right arm. Small round raised bumps on lower, inside of left forearm (about 3-4.) Then gastoinstestinal symptoms with diarrhea (second bout more severe.) Subtle red coloration on trunk that when stroked with finders turned white. Trunk itching, genitals itching. Hot burning hands, feeling of unease. The symptoms have lasted for days. Injected on 2/5 still having symptoms on 2/23. Taking Benadryl.
70 2021-02-22 hot flush The patient began to have hot flashes and some dizziness. She felt "disoriented in her eyes," while ... Read more
The patient began to have hot flashes and some dizziness. She felt "disoriented in her eyes," while also having a slight headache. The feeling went away after 10 minutes and began 15 minutes after receiving her second Pfizer vaccine dose.
70 2021-02-22 pain in extremity When I left facility I had a mild headache. After getting on the highway face turned beet red with ... Read more
When I left facility I had a mild headache. After getting on the highway face turned beet red with mild swelling. Throat felt tight but not closed. An hour later the headache was worse. Took a Tylenol and slept for an hour. Woke up itchy. Glands on right side of neck very sore with pain radiating to base of skull. Swelling in face subsided after a few hours. Later at night I was still itchy with some small red hives on my arms, legs, and stomach. Arm very sore. Woke several times during the night with nausea. Woke up morning of the 20th with mild dizziness, upset stomach and severe diarrhea, Serious headache all day. Hives subsided but was still itchy. On the 21st felt much better but still with diarrhea. Today is the 23rd and no diarrhea since this morning.
70 2021-02-22 tremor, pain in extremity pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the ... Read more
pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache. She felt like she had fever but she said it was only 99. Her left arm was swollen, red and hot around the injection site. Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
70 2021-02-23 tremor, feeling cold A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizur... Read more
A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizure because my lack of control was evident in my movements. With my heaviest PJs on, it took 8 blankets to finally warm me up. I am on a CPAP machine but I was having a hard time getting my breath. I was also nauseous but never threw up. I finally got back asleep a little after 3 am but woke several times after that. This morning, I had a terrible headache and can't get rid of it. Although I feel better than last night, I feel lousy. It is now 2 pm and I just want this to be over. On the first shot, I didn't have any reaction at all.
70 2021-02-23 weakness Body aches, felt feverish, weakness, headache, fatigue, overall malaise
70 2021-02-23 difficulty speaking Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Lo... Read more
Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.
70 2021-02-23 weakness Pt. from tent 3 at observation lane was complaining of light headedness + generalized weakness. Par... Read more
Pt. from tent 3 at observation lane was complaining of light headedness + generalized weakness. Paramedics assessed. Once symptoms subsided paramedics released pt. to leave.
70 2021-02-23 pain in extremity Sore arm....48 hours
70 2021-02-23 pain in extremity, weakness, tremor arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then al... Read more
arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then also and found swelling like an orange, swelling lasted 8 days but was decreasing in size. became very cold and went into violent shaking tremors - 4-6 of those as i lost count. these violent tremors were from 10:30 pm on monday through 1:45 am tuesday. i had one other tremor on day 4. fever for 4 days and spiked on 5th day ranging from 101.8 - 100.3, severe all over body aching especially right armpit, lower back especially right side and across shoulders, aching lasted 8/9 days and lessened after 5 days. pressure on chest which ranged from very heavy to mild and in some form lasted 10 days, hurt to breath but i could breath. woke up on night 7 with heavy, painful chest pressure on left side but it subsided in 6-8 hours. nasty headache began day 2 and lasted several days; nothing relieved it. headache for 4/5 days and then off and on for a few days. i am not prone to headaches. coughing which lasted several days. on third day post vaccine had violent nausea one time. became weak and lightheaded. no energy and stayed in bed 5 days. on day six i started getting out of bed for several hours multiple times/day. weak and very low energy. exhausted easily. i had some of these symptoms for 10 days. the first 5 days were terrible and i was very ill.
70 2021-02-23 feeling cold, pain in extremity, tremor extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then ... Read more
extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then walked to parking garage. Breathing became labored as I walked the block to car - no one was around. Pulled off mask and sat in car - it subsided in 15 minutes. Body temp was 94.5 remainder of the day. 96.5 today. Awoke nauseated, headache, left foot and hand pain and very sore left arm. Nausea stopped about 3:00 pm, when body tremors started again. Cold all day with no energy
70 2021-02-23 flushing flushing of face within 10 minutes, light rash arms, and trunk; flushing of face within 10 minutes, ... Read more
flushing of face within 10 minutes, light rash arms, and trunk; flushing of face within 10 minutes, light rash arms, and trunk; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 23Jan2021 01:00 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to receiving bnt162b2. The patient was not diagnosed with covid prior to vaccination. The patient was not pregnant. Medical history included allergies to tree nuts, bees, penicillin, and sulfa. Concomitant medications were included hormones, fluticasone propionate, salmeterol xinafoate (ADVAIR), and esomeprazole sodium (NEXIUM). The patient experienced flushing of face within 10 minutes (as reported), light rash arms, and trunk on 23Jan2021 01:15 PM (as reported). The patient was not tested for covid post-vaccination. The patient received Benadryl as a corrective treatment. Outcome of the events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.
70 2021-02-23 feeling cold nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to... Read more
nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
70 2021-02-24 feeling hot Patient felt hot and given a cold pack. State throat symptoms similar to Phenergan reaction. Subsi... Read more
Patient felt hot and given a cold pack. State throat symptoms similar to Phenergan reaction. Subsided after a couple of minutes. Observed for 30 minutes and released.
70 2021-02-24 speech disorder, unresponsive to stimuli Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vacci... Read more
Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vaccination waiting period, patient became unresponsive and exhibited convulsion like movements in her waiting chair. Pharmacist quickly evaluated patient and patient was only minimally responsive to painful stimuli only. Breathing was rapid, shallow, and irregular with an expiratory wheeze heard upon auscultation. Patient was slouched in chair but supporting self and had a strong grip with her left hand. Skin condition was warm but diaphoretic. Ambulance 911 service was called. No swelling of the throat, mouth, face, nor lips was seen. Patient continued to be non-responsive, with non-comprehensible sounds, and was not opening eyes or following commands. Due to worsening ability to breath and wheezing on expiration, epinephrine 0.3 mg was administered intramuscularly into the left thigh at 1230 on 2/25/2021. Approximately 5 minutes after epinephrine administration, the patient?s work of breathing improved, wheezing was diminished upon expiration, and respiratory rate had slowed to 16 breaths per minutes. BP was 160s/80s and HR 98 (after epinephrine administration). Patient began opening eyes spontaneously but was still not following commands. Ambulance service then arrived, report was given, and patient was transported to Hospital Emergency Department. Patient was under the care of Doctor at the emergency department and received albuterol/ipratropium nebulization, dexamethasone 10 mg Iv, famotidine 20 mg IV, and magnesium sulfate 2 g IV. After the physician evaluated the patient and talked with family, the patient?s family stated that the patient has a history of anxiety related reactions such as this with convulsion like activity. Doctor then determined that the patient did not have an anaphylactic/allergic reaction and instead had a anxiety related vasovagal type reaction. Doctor stated that the patient could receive the second COVID-19 vaccine dose in 3 weeks without issue. Patient then discharged from Emergency Department (unsure if AMA). Patient then presented to the pharmacy with her daughter after discharge to fill in staff on the outcome of the reaction. Patient appeared to be at baseline mentally and physically. Pharmacist contacted Emergency Department to discuss case with patient?s nurse to obtain information about medications received in the emergency department. Patient daughter stated that she would like to be present for second dose of vaccine to help avoid a similar anxiety related reaction from occurring.
70 2021-02-24 hot flush Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face beco... Read more
Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face becoming hot, her cheeks being red, and a headache. EMS evaluated patient on-site. Patient was hypertensive (206/96). EMS transported patient to Emergency Department for further evaluation. In ED, patient was still hypertensive, but in no acute distress. Per patient, she was taken off losartan by PCP in September secondary to hyperkalemia. ED physician administered losartan and Tylenol. Patient was discharged with HTN, HA, and vaccine reaction.
70 2021-02-25 weakness, numbness Rapid heartbeat Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of ... Read more
Rapid heartbeat Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of tongue Chills, weakness, headache, blurred vision for a short time Took Benadryl on my own, continued taking non drowsy Claritin 5 days after shot feeling better. Still have slight numbness in my lips and feeling weak
70 2021-02-25 pain in extremity Severe pain in left shoulder and left arm. It felt like I had ripped a muscle or tendon and would h... Read more
Severe pain in left shoulder and left arm. It felt like I had ripped a muscle or tendon and would hurt constantly. Pain scale of 7-9 all day and night for a week. Daly?s 6& 7 the pain did subside slightly and remain d light pain for two more days
70 2021-02-25 pain in extremity fainted twice while visiting the bathroom; BP was 145/85; arm was sore; This is a spontaneous report... Read more
fainted twice while visiting the bathroom; BP was 145/85; arm was sore; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot_number m000007217771.CSN20 447277212), via an unspecified route of administration in left arm on 11Feb2021 16:45 at single dose for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included hypertension, blood cholesterol increased, anxiety, allergies, allergies to penicillin, Sulfa drugs and Crustacea. The patient previously took tetracycline and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Concomitant medication included olmesartan medoxomil (unknown manufacturer), diltiazem hydrochloride (unknown manufacturer) and sertraline hydrochloride (SERT). On 12Feb2021 her arm was sore but she was not really feeling anything more. On 13Feb2021 morning at 04:45 the patient fainted twice while visiting the bathroom. Upon checking of the BP it was 121/75. Later in the day the BP was 145/85. The patient was completely normal before the shot. It seems that the vaccine affected my BP. The outcome of the events was recovered in Feb2021. No treatment was performed. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
70 2021-02-26 tingling Anxiety and tingling
70 2021-02-26 involuntary muscle movements, flushing EMT noticed client, (DOB 7/1/1950), was sitting in post-vaccine waiting area with flushed face withi... Read more
EMT noticed client, (DOB 7/1/1950), was sitting in post-vaccine waiting area with flushed face within 15 min of receiving the COVID vaccine (Pfizer, lot #EN6202, expiration date 6/30/2021, dose 1). EMT approached client, asked how she was feeling, client reported feeling fine. At 1337 EMT took oxygen saturation 98% and pulse 96. EMT informed PHN of client's condition and possible language barrier. EMT stayed with client as PHN called over client's family member who was waiting outside. Family member used FaceTime to call client's daughter for help with translation. Per client's daughter, client suffers from anxiety, asthma, hypertension and hyperlipidemia. EMT took vital signs: blood pressure 140/Palpated, respiratory rate 24, oxygen saturation 97%, pulse 96. Client's list of medications: diltiazem, clopidogrel, atorvastatin, Montelukast, albuterol sulfate, incruise Ellipta, flucatisone propionate, vitamin D, famotidine, benzonatate, losartan, gabapentin, duloxetine, prednisone, and vitamin C. Client's daughter translated and reported that client felt anxious, warm, and had difficulty breathing similar to her asthma flares. PHN noted client's arm was warm to touch, face flushed, anxious movement as noted by repeated touching chest and face, no use of accessory muscles noted. At 1346, vital signs: oxygen saturation 95%, pulse 92, blood pressure 138/70, respiratory rate 24. At 1350, PHN offered client benadryl, client consented and took 2 capsules of benadryl (50mg dose) orally. At 1352, client moved to chair outside on patio in front of CWS in the shade as offered by PHN, gait steady and assisted by family member. At 1352, client signaled to family member that she felt better, PHN noted decreased flushing, posture relaxed with arms at sides while sitting in chair outside. At 1402, PHN advised client and family member to have client follow up with PCP within 24hrs or as soon as possible thereafter. At 1413, vital signs: oxygen saturation 96%, pulse, 84, blood pressure 140/90, respiratory rate 16. PHN noted client yawning, no redness noted in face, no longer warm to touch at 1415. At 1427 vital signs: oxygen saturation 97%, pulse 85, blood pressure 140/100, respiratory rate 16; PHN advised to call 911 if adverse reaction occurs. At 1430, client left, gait steady, with family member to the car. Family member drove.
70 2021-02-26 pain in extremity Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweat... Read more
Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweating, tiredness, slight nausea, intermittent headaches, strong muscle and joint pains, slight swollen glands in neck
70 2021-02-27 numbness, muscle twitching, weakness Weakness, vertigo, feeling unsteady, nausea, numbness in extremities, involuntary twitching in calf ... Read more
Weakness, vertigo, feeling unsteady, nausea, numbness in extremities, involuntary twitching in calf muscle and arms, itchy feeling under the skin, symptoms lasted 4-5 days, improved with Benadryl,
70 2021-02-28 hot flush, pain in extremity 2-22 6PM extremely sore left arm 2-22 9PM could not move left arm up but about 8" 2-23 10AM-... Read more
2-22 6PM extremely sore left arm 2-22 9PM could not move left arm up but about 8" 2-23 10AM-12PM Flushed hot to touch cheeks-normal temperature 2-24 9AM rash on left underarm....had scratched during the night & arm sore to touch in that area 2-25 9AM rash had subsided but arm still sore to touch
70 2021-02-28 pain in extremity Generalized pain that started on the extremities and has moved to the spineal column. Symptoms were ... Read more
Generalized pain that started on the extremities and has moved to the spineal column. Symptoms were present prior to vaccine but have worsened. Started roughly 3 days post vaccination. OTC pain medication lessens symptoms. Pain is constant and randomly spikes.
70 2021-02-28 flushing hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, v... Read more
hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, vomiting, chills--resolved after 9 hours
70 2021-02-28 pain in extremity, numbness nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she... Read more
nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she has a cough in her throat; swelling and soreness of her arm; swelling and soreness of her arm; Tightness in her jaw; Numbness in hand; difficulty swallowing; taste in her mouth; dry mouth; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in left arm on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunization in a clinic. Medical history included ongoing underactive thyroid, cataract surgery on 14Oct2020 and on 28Oct2020, and cholesterol (abnormal). Concomitant medications included ongoing levothyroxine for underactive thyroid and ongoing rosuvastatin calcium for cholesterol. The patient experienced nervousness, slight swelling/tingling in lips, dizziness, like she has a cough in her throat, swelling and soreness of her arm, tightness in her jaw, numbness in hand on 26Jan2021. The patient also had difficulty swallowing, had taste in her mouth, and dry mouth in Jan2021. The patient on the line calling about the COVID-19 vaccine. She got the shot yesterday (26Jan2021) and was calling to report on the reaction that occurred. She initially stated she had slight swelling/tingling in lips, difficulty swallowing, numbness in hands, jaws became tight, and nervousness which she is still experiencing. She mentioned she took benadryl. She was wondering if she should go and get the second shot. The patient first experienced dizziness which lasted for a second and this occurred while waiting in the lobby for observation after getting the vaccine. Slight swelling and tingling in lips were noticed two minutes after the dizziness. It felt like a tingle sensation. She clarified she does not necessarily have difficulty swallowing. It was not so much she could not swallow, but it was like she has a cough in her throat. It feels like she could cough but would need to keep swallowing and drinking water. Once she got the shot it caused her to get a taste in her mouth. The feeling like a cough in her throat has gone away, but now she feels nervousness, dry mouth, and she still has that taste in her mouth from getting the shot. She had swelling and soreness of her arm, but she knew that was to be expected which started an hour after getting the vaccine. Tightness in her jaw was noticed an hour after getting the vaccine. The numbness in hand started at the same time as the tightness of her jaw. Her left hand is what went numb, and she had the vaccine administered in her left arm. The nervousness is getting better, but she felt very nervous. She also mentioned she has thyroid problems and is not sure if this has anything to do with it. She had this nervousness feeling 2 hours after getting the shot. Patient is scheduled to get the second vaccine on 18Feb2021. Benadryl has helped a lot. The patient has no additional vaccines administered on the same date and has no prior vaccination within four weeks. The events did not require emergency room and physician office visit. Vaccine was not administered in a military facility. The patient was recovering from events nervousness, slight swelling/tingling in lips, swelling and soreness of her arm, tightness in her jaw, and numbness in hand; recovered from dizziness on 26Jan2021; recovered from event "like she has a cough in her throat" on unspecified date; not yet recovered from event "taste in her mouth"; while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
70 2021-03-02 seizure Pfizer-BioNTech COVID- 19 Vaccine EUA: Wife of patient called Primary Care Physician to inform that ... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: Wife of patient called Primary Care Physician to inform that patient had received dose #2 of Pfizer COVID vaccine, and later that evening experienced a seizure and expired.
70 2021-03-02 cold extremities Pt reported extremely cold feet app 10 minutes after vaccine administration. Vital signs were taken,... Read more
Pt reported extremely cold feet app 10 minutes after vaccine administration. Vital signs were taken, initial BP 186/87, P 65, PO2 100%. Pt said BP was extremely high for her. F/U BP = 194/84. Pt was subsequently assessed by MD, who knew pt as a PCP. Reported elevated BPs for pt in past, but not that high. Next BP 202/97. Pt then went to the bathroom, took a walk outside. Came back, manual BP 160/89, coldness in feet resolved. Pt was started on amlodipine 2.5 mg PO daily, to f/u with PCP in 2 weeks.
70 2021-03-02 flushing all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size... Read more
all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; redness of the skin; whole body was in pain; severe allergic reaction; felt unwell; Joint muscle pain; flushed red; Tiredness; Injection site pain; joint and muscle pain; joint and muscle pain; white blood cell count on the lower side; possible damage to the kidneys; could have been possible that she had COVID and was asymptomatic, or she had it; cold; not feeling normal; This is a spontaneous report from a contactable consumer (patient) Medical information team. A 70-years-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13Feb2021 at single dose for COVID-19 immunization. Medical history included dystonia and migraines from an unknown date and unknown if ongoing, COVID-19 antibody test positive from Nov2020 to an unknown date. The patient was taking unspecified concomitant medication for dystonia and migraines. The patient experienced a "severe allergic reaction" to her first dose of BNT162B2 in Feb2021. She had all-over body rash that was "very red, like a tomato" and showed up 35-40hours after her dose. She states her doctor does not recommend she get the second dose. The patient meant by allergic reaction, she had a number of things, she experienced tiredness, injection site pain, joint muscle pain, she felt unwell, this all happened on the Saturday, the same day she got the vaccine on 13Feb2021. Then on Sunday 14Feb2021, all the symptoms she spoke about were still there and so she rested all day. On 15Feb2021, she looked at her elbows, clarifying the inside of elbow, her elbow creases, and on both elbow creases the skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen down to her thigh, it was working it's way down to the knee, the color was like a beet red, tomato color, it was under the arms, started with elbow, was at her neck. The more down the redness spread, the more it red in color it also got. When she noticed this she called the doctor. When she called the doctor, the doctor said get over to the Emergency Room right away. Her husband and her were both on the phone and were telling the doctor that she doesn't want to go to hospital, she asked if she can just come into the doctors office. The doctor said No. He told her that needs to get special lab work done, and he needs to send her information over to the ER. He said this could do possible damage to the kidneys. The doctor said lets not forget the last time she did a blood test, which was in Nov2020, at that time she came up positive with COVID antibodies. It could have been possible that she had COVID and was asymptomatic, or she had it. The doctor said that they need to do another COVID test or it could be she had a COVID cold or a cold with antibodies, her doctor doesn't know. The fact that she had that test that came back with COVID antibodies test but not have COVID in Nov2020 was something to consider. He was concerned may be there is more to this, or just a rash. The doctor said that he is not equipped say what it should be. The doctor said he will speak with them at the hospital. Tiredness subsided yesterday afternoon on 15Feb2021, it subsided before she went to the ER visit. Right now, it's kind of like a lasting effect because she is not feeling normal. The injection site pain was still there but not as bad. The joint muscle pain subsided this afternoon around 1 o clock. It first began a half hour after leaving the stadium and she was experiencing it while driving back home, the pain continued and got worse. When she got up on Sunday morning her whole body was in pain, she was not getting better on Sunday and that's when she sat on couch rest of the day. For red skin, with the temperature of the skin, she didn't feel it to see if it was hot or anything, it was more this feeling that its just not going away getting worse, it didn't feel hot, there was no texture on the skin either. She just noticed she was flushed red. She called the doctor first, and he said that he was sending information to the emergency room. Then she went to (name of place withheld) ER. They took her temperature, there was no fever. She was then relieved from the ER in 2.5 hours and went home. She still has redness on the skin. In the hospital, they gave her 40 mg of prednisone and an injection or Benadryl, and prescription for prednisone to take for the next 4 days while tapering down. She did take Benadryl about 2 hours ago, she did notice all the sudden she was getting itchy. She is less itchy now. With the itchiness, she just observed this about 2 hours ago. She took Benadryl, she has somewhat improved, she is still itchy but not to the point that she will scratch heavily. She does not have her COVID CDC Card at the moment, her husband has that information but he is on a conference call with a client and she cant disturb him. The patient was scheduled for a second dose on 06Mar2021. That's where she has a question, the doctor is saying that he is not sure about getting second shot. They took lab work at the hospital and said everything was fine except for white blood cell count, it was on the lower side in Feb2021. She has had no vaccines on the same day or in the 4 weeks prior. She hasn't had any vaccines. She did have to visit the emergency room. She only called the doctors office, the doctor said not to come in and go tot he ER. She has No relevant family medical history that she would like to share. The severe allergic reaction, "skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen", injection site pain, redness of the skin, itchiness, joint muscle pain and whole body was in pain was recovering. The event tiredness recovered with sequelae on 15Feb2021 and the event joint and muscle pain was recovered on 16Feb2021. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
70 2021-03-02 facial pain, pain in extremity, weakness fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no uri... Read more
fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no urine output for 24 hrs, vertigo, fatigue, severe stabbing pains in face and head, stiff neck, no appetite, difficulty swallowing, pain in joints, chest pain, pain across upper back, stomach pain,. Symptoms lasted for 3 to 4 days. Severe head pain lasted 4 days. Could not raise left arm for 24 hrs after injection. After 6 days fatigue and general malaise still present. Stomach pain still comes and goes.
70 2021-03-02 feeling hot pain at injection site; swelling; warmth; redness; This is a spontaneous report from a contactable n... Read more
pain at injection site; swelling; warmth; redness; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EM9810) via intramuscular in the left arm on 10Feb2021 13:15 at single dose for covid-19 immunisation. Medical history included hypothyroid. Known- allergies included sulfamethoxazole; trimethoprim (BACTRIM). Concomitant medication included levothyroxine, tramadol, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID). There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The patient experienced pain at injection site, swelling, warmth, redness; all on 12Feb2021 08:00. The events resulted in physician office visit. The patient was hospitalized from Feb2021 for the events. Treatment received for the events included cefalexin (CEPHALEXIN) orally; methylprednisolone (MEDROL) dose pack; famotidine; and cetirizine hydrochloride (ZYRTEC). The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
70 2021-03-02 weakness she experienced dizziness and weakness; she experienced dizziness and weakness; This is a spontaneou... Read more
she experienced dizziness and weakness; she experienced dizziness and weakness; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL9262, expiry: May2021), via an unspecified route of administration (at the age of 70years) on 27Jan2021 at single dose for covid-19 immunisation. Medical history included hypertension and Crohn's. Concomitant medications included lisinopril, estradiol, levothyroxine and adalimumab (HUMIRA) for Crohn's. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Wednesday. Next morning (on 28Jan2021) from Thursday until Saturday, she experienced dizziness and weakness as stated, "when I woke I was severely dizzy and just weak and that is continued yesterday, well let's say Thursday, Friday and yesterday. I am feeling better today but I wanted to report that". The patient wanted to know if she should receive the second dose of the vaccine because these two symptoms were reported as signs of a severe allergic reaction and that's a contraindication to receive the second dose of the vaccine. The patient had some blood work done on an unspecified date. The patient took some diphenhydramine hydrochloride (BENADRYL) according to her physician. The patient further stated, "I am just, I guess concerned, it does say on the paperwork that I received that you should not take the second dose if you had a severe allergic reaction which it list the dizziness and weakness one of those included so I am assuming that I should not take the second dose." The patient considered the events as non-serious. The outcome of the events was recovering.
70 2021-03-03 burning sensation, pain in extremity Patient woke up in the middle of the night the same day she received the vaccine and noticed pain an... Read more
Patient woke up in the middle of the night the same day she received the vaccine and noticed pain and burning on her upper left leg. She saw her doctor the next day who diagnosed her with shingles. The outbreak spread to the back of her knee in the meantime. She was prescribed ointment and medication to treat shingles.
70 2021-03-03 pain in extremity right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen ... Read more
right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
70 2021-03-04 hot flush, feeling cold Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by swea... Read more
Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by sweating hands/palms followed by feeling very cold and then cycling back to hot flash, more sweaty palms, & back to chills. Minor nausea. Lasted from 8:15am til 11:30am. I called my care team at clinic they suggested that I call "911", but I did not call "911". My daughter who is a nurse came over to my house & stayed with me until 11:30am. On 03/05/2021 I woke up at 8:00am with a mild headache, minor muscle aches, tired, a little brain fog, & minor nausea which is continuing as of 10:35am as I am completing this form.
70 2021-03-04 pain in extremity, cold extremities From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches.... Read more
From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches. General ill feeling. Couldn?t go to sleep. Began to feel horrible. Cold feet. Took an Advil and within 15 minutes all symptoms went away.
70 2021-03-07 pain in extremity Aches, stiff joints, headache, very tired & very, very sore arm
70 2021-03-07 tremor began to pass out; because every time I tried to lift my head, I would start blacking out again; diz... Read more
began to pass out; because every time I tried to lift my head, I would start blacking out again; dizzy; diaphoresis; fell against the wall; violent high abdominal pain; n having multiple, large formed bowel movements; shaking; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer. This 70-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EM9809) , via an unspecified route of administration on 12Feb2021 at 09:45 (at the age of 70years old) at single dose for covid-19 immunisation. Medical history included hypersensitive to latex, allergies to levaquin, ddavp, CT scan dye, codeine, fentanyl, primary immune deficiency, myasthenia gravis, Sjogren's, autonomic neuropathy, myelodysplastic syndrome, von Willebrand's, Barrett's esophagus on unknown date and unknown if ongoing and received Pfizer Covid vaccine (dose 1, Lot: EL9261) on 22Jan2021 at 2:45am on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant concomitant medication was not provided. At approximately 9:50 AM on 12Feb2021, the patient received second Pfizer Covid-19 vaccine in left arm at Administration facility. The patient waited the 15 minutes post injection. At approximately 10:19AM, the patient left site & drove to her home without issues. At home approximately at 11:20am, she had violent high abdominal pain like she never had before. she proceeded to the commode and began having multiple, large formed bowel movements then began to pass out. She began to have diaphoresis and violent shaking and chills. She had passed out on commode and fell against the wall. She later managed to pull pants up and crawl with head hanging down stated that because every time she tried to lift her head, she would start blacking out again. This continued until after approximately 20 minutes. She managed to pull herself up to the couch and raise legs high above heart and head and let head hang off couch to restore blood pressure. The patient mentioned that shot triggered something with her autonomic nervous system. On 22Feb2021, she was still with nausea, fatigue and dizziness. The outcome of events was not recovered. No treatment was received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
70 2021-03-07 pain in extremity pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting for hersel... Read more
pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 70-year-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9809), on the left arm, via an unspecified route of administration on 05Feb2021 17:45 (5:45 pm) at single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP) and allergies to medications, food, or other products, both from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received an unspecified medication within 2 weeks of vaccination. On 05Feb2021, it was reported that the patient experienced pain in arm. No treatment was received. The event was considered as non-serious and it did not result in death, life threatening condition, hospitalization, disability, or congenital anomaly. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination. The patient was vaccinated in a school. The outcome of the event was reported as not recovered. The patient is not pregnant.
70 2021-03-10 seizure Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mo... Read more
Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mouth, neck, shoulder; Muscle type convulsions in neck, shoulder, arms and upper chest; This is a spontaneous report from a contactable consumer reported for self. This 70-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via intramuscular on 24Feb2021 at 10:00 AM at single dose in left arm in a pharmacy or drug store for COVID-19 immunization. The patient's medical history included high blood pressure. The patient had known allergies: anabolic steroids, many antibiotics. The patient did not have COVID prior vaccination. The patient's concomitant medications included hydrochlorothiazide, triamterene (MAXZIDE) and vitamins. At 24Feb2021 at 10:00 PM, the patient experienced muscles in neck, jaws and throat started clinching up and she could not swallow. The patient began having issues breathing. The patient was advised to go to emergency room (ER). At ER, patient started with muscle type convulsions in neck, shoulder, arms and upper chest. The patient had several episodes. Doctor administered diphenhydramine hydrochloride (BENADRYL) intravenously, did blood and urine workup. After 4 hours the shaking stopped, and the muscle contractions lessened. The patient was sent home. Next day 25Feb2021, she still had some residual muscle tightness in right jaw, mouth, neck, shoulder. On third day 26Feb2021, she had light shaking of hands and arms. The patient was still taking 25 mg diphenhydramine hydrochloride every 8 hours. She added ibuprofen (ADVIL) because she also had muscle pain and headache. The patient was recovering from the events. The patient did not test COVID post vaccination. Information on lot/batch number has been requested.
70 2021-03-14 pain in extremity left arm pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old fem... Read more
left arm pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EM, expiration date unknown) via an unspecified route of administration in the left arm on 05Feb2021 13:30 (at 70 years old) at a SINGLE DOSE for COVID-19 immunisation. The patient's medical history included bulging discs and known allergies to Penicillin, Dilaudid, and Sulphur. Concomitant medications included ascorbic acid (VITAMIN C), colecalciferol (D), biotin, calcium, magnesium, and curcuma longa (TURMERIC); all from an unknown date for unspecified indications. The patient received these medications within 2 weeks of vaccination. At 70 years old, the patient received the first dose of BNT162B2 (lot number: EM, expiration date unknown) via an unspecified route of administration in the left arm on 15Jan2021 11:30 at a single dose for COVID-19 immunisation and experienced pain in left knee and down to ankle and knee arthritic. The patient was not pregnant at the time of vaccination; was not diagnosed with COVID prior to vaccination; did not receive any other vaccines within 4 weeks prior to BNT162B2; and has not been tested for COVID post vaccination. It was reported that after the administration of the second dose, the patient experienced left arm pain on an unspecified date. Patient realized that the pain was akin to what she felt in knee (after the first dose) but not as bad. No treatment was received in response to the event. Outcome of the event was recovered with sequelae. The event was reported as disabling. Information on batch number has been requested.
70 2021-03-14 breast pain, pain in extremity syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; sor... Read more
syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
70 2021-03-15 seizure, unresponsive to stimuli Phone call from husband on 3/12/21 at 2:43 pm that after leaving the Health Department around 12:20 ... Read more
Phone call from husband on 3/12/21 at 2:43 pm that after leaving the Health Department around 12:20 pm they drove to restaurant and his wife ate lunch. They drove home and she was resting in living room and he found her at 1:30 pm unresponsive. He called ambulance and she was transported to the emergency department at Center. He reported that the doctor was running tests and he would let me know what they find out. 3/16/21 3:45 pm phone call to, husband and he said patient was sent by flight for life to Center on 3/12/21. He reports that it was determined she had a seizure and then had another in the emergency department and was intubated due to low oxygen levels.
70 2021-03-15 feeling cold, weakness she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; c... Read more
she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; chills but no temperature; fever; fatigue/exhausted; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN9810, expiry: unknown), intramuscular in the muscle of her right shoulder on 05Feb2021 11:00 at a single dose for covid-19 immunization at a public health department. The patient has no medical history and concomitant medications. The patient is experiencing chills but no temperature on Feb2021, fever on Feb2021, fatigue on Feb2021, nausea, and no energy. She had her first shot last Friday (05Feb2021) and was fine. She stated that yesterday afternoon (11Feb2021), she felt really bad. She called the clinic to see if it was symptoms of Covid. She stated that she was freezing cold, but no temperature registered on 12Feb2021 at 13:00. Her head hurt on 11Feb2021 13:00 and she took Ibuprofen but it never let up, so she took Tylenol. She was sleepy on 11Feb2021 14:00 and was napping so she laid on the couch. The patient was also nauseous on 11Feb2021 14:00 but never threw up. She called the clinic to see if she should get tested for Covid. She stated that since she got up that she is exhausted, felt like she had no energy on 11Feb2021 14:00. The patient wanted to know if she needed to be concerned or if this is something that will run its course. She had to go get blood work at the hospital on Wednesday and that everyone had on masks and she did not think that she was exposed. The patient has no prior vaccinations (within 4 weeks). The outcome of the events feeling cold and feeling of total lack of energy was recovering, head pain and nausea recovered on 11Feb2021 while event sleepy was not recovered. The outcome of the other events was unknown.
70 2021-03-16 pain in extremity I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chi... Read more
I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chills; nausea; I would throw it up; arm was so bad, it had it's own pulse, a pulse of it's own, I couldn't lift it at all plus the pain was like a tooth ache pain; checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90; my chest was shortness of breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored program. A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 24Feb2021 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included viruses, flus (I have had viruses, flus my whole life), five surgeries, gallbladder removed, and asthma, all from unspecified dates and unspecified if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) on an unspecified date, at the age of 70-years-old and experienced a very sore arm. On an unspecified date in Feb2021 the patient experienced, "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath". The clinical course was reported as follows: "I wanted to call today because I got the Pfizer COVID Vaccine 3 weeks ago, 03Feb2021 it was. After the first dose I had a very sore arm and that was it. It was more sore than normal vaccine, but it was that was all I had. After the second dose I was not aware that I would get sick to the extreme that I did. I found out afterwards that other people have said this, I did not know at the time. I thought I was going to die. I am a 70-year-old woman, I am not young, and I have had viruses, flus my whole life and I got so sick. First, I had over a 103 temperature, it came on suddenly, 12 hours to the minute after I got the vaccine. On top of that I had such bad chills I never saw anything like that in my life, 5 blankets on top of me, sweaters, sweatshirts and the fever was so high. I could not keep the Tylenol down because I had nausea and I would throw it up. So, I could not even get rid of it. Then on top of that my arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all, plus the pain was like a tooth ache pain, it was excruciating. I have had 5 surgeries, my arm hurt worse than all 5 surgeries put together. And I had my gall bladder removed and everything, nothing hurt to this extent. Now also I have asthma, nothing severe but I do have asthma, so I have one of those little oximeters and you put it on your finger and it checks your oxygen level and normally its 98-99, it went down to 91, all night it was 91, my chest was shortness of breath. I was ready to go to the hospital. And I did not know it was going to be that bad." When clarified about the treatment the patient stated that "yes, the Tylenol helped once I could hold it down. The doctor gave me something to stop the vomiting and the nausea. And then I could take the Tylenol and then the Tylenol worked great. But at first, I was so sick I could not hold the Tylenol down in my stomach I would throw it up, that was the problem." When asked about lab work the patient stated that she had not had lab work done since the first vaccine. She stated that she had stayed in the house because she had other health issues and was afraid to come out for 11 months. So she had not gone out to get anything done. The patient stated that she called because if a third dose was needed, she suggested that a smaller dose be given to small people. She stated that she took childrens medicine most of the time because she was tiny. She wanted to know if Pfizer in the future would be making doses for small people and doses for bigger people. Her suggestion was to have a separate booster to go by weight or by gender, men usually did not experience the same. The clinical outcomes of the events "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath" were all recovered/resolved on unspecified dates. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
70 2021-03-16 pain in extremity, migraine She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/p... Read more
She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume. A 70-years-old female patient received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation . Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections. The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting, swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.
70 2021-03-16 pain in extremity Urinary tract infection; Arm bothered her with first shot, it was just very sore; This is a spontane... Read more
Urinary tract infection; Arm bothered her with first shot, it was just very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 21Jan2021 at single dose as the patient didn't want to get Corona and die. Medical history included compromised immune system, asthma which was diagnosed in the late 80's or early 90's, fibromyalgia from 2000 and ongoing, and being sensitive to Bandaids. Concomitant medication was reported as none. The patient received the first shot 3 weeks ago on 21Jan2021. She mentioned that she was fine and the only thing that bothered her was her arm, but it was fine, like she knew she had a shot. Her arm bothered her with the first shot, it was just very sore on 21Jan2021 and lasted about maybe 24 hours. The patient also experienced urinary tract infection last week (Feb2021) and took CIPRO for 10 days which she was still on. She told her doctor she would get the second shot and said that it was not a problem. The outcome of the event pain in arm was recovered on 22Jan2021 and unknown for urinary tract infection.
70 2021-03-17 feeling hot thought she would pass out and it went downhill from there; flu symptoms; she got hot; This is a spo... Read more
thought she would pass out and it went downhill from there; flu symptoms; she got hot; This is a spontaneous report from a contactable consumer reporting for herself. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E18982), via an unspecified route of administration on 21Jan2021 13:00 by injection once to left arm at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included apixaban (ELIQUIS) as blood thinner. Patient was calling about COVID 19 vaccine. She had the first shot 21Jan2021, and had had flu symptoms ever since on 21Jan2021 and when they gave the shot they didn't ask for her allergies or anything, and she read on a letter given after, she was taking blood thinners, she was not sure what they do to the vaccine, that wasn't asked of her either, before she decided whether to take second or not, she needed some answers, she hadn't had the flu for 40 years. Her shot was at 1PM, and about 6 or 7PM that night, she got hot and thought she would pass out and it went downhill from there. Patient did not have some medical problems that she checked off when she registered, none of that came through either. Patient was thinking about not taking the second shot if she didn't get some medical information. The outcome of event flu symptoms was resolving, outcome of other events were unknown.
70 2021-03-24 tremor, muscle spasms Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She ... Read more
Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot; Fatigue; had a low blood sugar episode she supposed; passed out/Unconsciousness; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; crashed unconscious to the floor/fell/fell backwards/caught her foot under the vanity; This is a spontaneous report from a contactable consumer (patient) reporting for herself A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 20Feb2021 11:00 (Lot Number: EN6201) as a SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation. Medical history included breast cancer from 1988 to an unknown date , ovarian cancer from 2015 to an unknown date , she has had lymph nodes removed from her right arm "30 years ago" from 1988 to an unknown date, pass out from unknown date to unknown date. Concomitant medication included olaparib (LYNPARZA) taken for ovarian cancer from Feb2020 at 150mg, 2 tablets in the morning and 1-2 tablets at night by mouth.She says she is a little person and couldn't tolerate the side effects of that, so she varies how many she takes based on her side effects. She says she is supposed to take 300mg in the morning and 300mg at night. She says how she takes it is, she takes 150mg or one pill in the morning, then one or two at night depending on how she is doing. Historical vaccine information included BNT162B2 dose 1, lot no: EL9264, route left arm for Covid-19 immunisation. Past drug history included on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out. The patient reported approximately 15 hours after the shot, on 21Feb2021 she had muscle spasms almost to seizure amount of shaking, full body muscle spasms. She clarifies that her side effects didn't kick in until 02:30AM on 21Feb2021. She says at 07:00AM on 21Feb2021 she got up and went into the bathroom and passed out, and had a low blood sugar episode she supposed. She crashed unconscious to the floor. She said that could be from the shot, but she is also a high risk patient, a cancer patient, and is on a maintenance chemo drug. She says on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out, so she doesn't know if that was related to the COVID shot or not. No testing had been done on high risk patients, so she thought maybe this could be a good heads up for something someone else may experience. Her side effects were on and off for several hours, the shaking and spasms would subside and then start again. She says that they went away, and then she got up and passed out, and her foot was all messed up, she doesn't know what she did when she fell, but she had it checked and it was not broken, it was all bruised and swollen, but it was not broken. She says this was her right foot. She says she thinks she fell backwards, and she thinks she caught her foot under the vanity. On unknown date, she experienced bruising of foot, fatigue, foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot. Outcome of the events was unknown. Information on the lot/batch number has been requested.
70 2021-03-24 migraine I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It wa... Read more
I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It was so bad; that's how bad that was; I woke up with the migraine headache, I never had a migraine; I had complete chills; I had a bad fever; I had complete exhaustion; my whole body hurt; I had complete exhaustion; my whole body hurt; I started vomiting, I had repeated vomiting; I just could not feel any worse; No, I just don't feel great yet, I lost 5 pounds truthfully; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 16Mar2021 (at the age of 70-years-old) as single dose for covid-19 immunization. Medical history included thyroid disorder (thyroid). Concomitant medication included thyroid (NATURE THROID) for thyroid. On 17Mar2021, the patient experienced that she had a horrible reaction to the second shot of COVID 19; she really thought she was going to die; It was so bad; that's how bad that was; the patient woke up with the migraine headache, she never had a migraine; the patient had complete chills; the patient had a bad fever; the patient had complete exhaustion; her whole body hurt; the patient started vomiting, she had repeated vomiting; she just could not feel any worse. The patient stated, "No, I just don't feel great yet, I lost 5 pounds truthfully" and with treatment, the patient stated, "No, just drink water." The patient thought maybe other people were having this, were other people calling that they got that sick and the patient was not obese or anything. The patient know they make it like if they were overweight, terribly overweight, have a worse reaction, the patient was a little overweight but hardly any. The outcome of the events was unknown. Information on the lot/batch number has been requested.
70 2021-03-28 numbness, pain in extremity RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began havin... Read more
RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began having chest pain radiating down her arm, chest heaviness, right arm numbness, and some shortness of breath. Vitals BP:146/78, O2 94% on room air. Patient also pale and diaphoretic. Taken by ambulance to emergency room. Patient has extensive cardia history per EMT report: has pacemaker, had stress test and scheduled for a cardiac procedure. 3/29/21 Phoned patients daughter to follow up with patient's status. Patient does not have cell phone and speaks Bosnian. During hospital stay, she reports her O2 sats were low, had a heart cath. procedure,
70 2021-03-28 facial paralysis Sitting in the waiting room after the shot, I started to experience difficulty swallowing about 15 m... Read more
Sitting in the waiting room after the shot, I started to experience difficulty swallowing about 15 minutes after shot followed by tingling around both upper & lower lips. Doctor on site saw that I was having an event which he thought was either a TIA or Stroke because my smile was crocked, lip was drooping and BP was very high. The doctor ordered an Ambulance who transported me to hospital as the doctor said they were equipped to handle such an event as they are a Trauma 1 hospital.
70 2021-03-30 numbness Three hours post vaccination, I experienced for 30 minutes visual hallucinations left eye, the lower... Read more
Three hours post vaccination, I experienced for 30 minutes visual hallucinations left eye, the lower half the visual field (as though I had rubbed my eye hard.; I had photophobia as well; I also had left sided facial numbness that lasted 30minutes.; My tinnitus became much louder and that is continuing.; felt confused; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 11Mar2021 12:00 as SINGLE DOSE for covid-19 immunisation. Patient was not pregnant. Facility type vaccine was clinic. Medical history included fibromyalgia, chronic fatigue syndrome, non-specific autoimmune disorder, allergies to Sulfa, Penicillin-light rash each. Concomitant medications included fenofibrate and tizanidine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. Three hours post vaccination, patient experienced for 30 minutes visual hallucinations left eye, the lower half the visual field as though she had rubbed eye hard. Patient had photophobia as well. She also had left sided facial numbness that lasted 30 minutes. She noticed no drooping of eye lid or mouth. Her tinnitus became much louder and that is continuing. She felt confused for the rest of the day of vaccination. The events onset date were reported as 11Mar2021 03:00 PM. The adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit. Patient didn't received treatment for the events. The outcome of events was recovering. Patient have no Covid prior vaccination nor tested Covid post vaccination.
70 2021-04-03 pain in extremity right thigh pain Treatment : lovenox 80 sery
70 2021-04-06 pain in extremity, facial paralysis 4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, des... Read more
4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, described as unusual pain; thought a migraine was coming on. 5-7:00pm headache continues to worsen; chills; research on line side effects of Pfizer vaccine and they coincide with symptoms; 7:05 gets up to urinate (no assistance needed); screams out in pain 3 times while on toilet; starts to vomit; right side of face (eye and cheek and mouth droop like a stroke; left hand starts to curl. Loses consciousness immediately thereafter. 911 call; paramedics on the way; airway was swept and clear; gurgled breathing. Rushed to Hospital and assessed as having massive brain bleed. Pronounced dead at 10:22pm. Acute Hemorrhagic Stroke on Death Certificate.
70 2021-04-06 weakness Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, h... Read more
Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, her eyes are weak; Difficulty breathing; thought she was having a heart attack; dehydrated; fast heart beat that felt like her chest was full; fast heart beat that felt like her chest was full; Injection Site Pain; blood pressure fluctuated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (lot number: EN6202; expiration date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure and stroke from 2012 to an unknown date. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for stroke from 2012 and ongoing; clopidogrel bisulfate (CLOPIDA) and simvastatin both taken for high blood pressure from 2012 and ongoing; ongoing amlodipine, lisinopril, and metoprolol all taken for high blood pressure. On 27Feb2021, she took the first vaccine. From that day, for 2 days, she had injection site pain. On 07Mar2021, she started having tiredness, headaches, chills, fever, felt nauseated, had a fast heart beat that felt like her chest was full and thought she was having a heart attack, dizziness, weakness, felt sick, and difficulty breathing. The patient added that she can't see as good, her eyes are weak. She was going to make an appointment to get her eyes checked. For dizziness event, she has to sit on the side of her bed for 10 minutes and she was still dizzy. She has to hold on to something because she feels like she is going to fall. She was given meclizine three times a day for this event. For tiredness event, she stated that it fluctuates during day. After she takes a paracetamol (EXTRA STRENGTH TYLENOL) and lays down for a while, she feels ok and then she feels tired again. For fast heart beat that felt like her chest was full and thought she was having a heart attack event, it comes and goes, she had it yesterday (21Mar2021) but hasn't had it today (22Mar2021) but she doesn't know if it is gone. Her symptoms were usually in the morning when she first gets up. She has been to the emergency room (ER) on 07Mar2021 and on 13Mar2021 and they say that nothing is wrong. On 07Mar2021, they gave her an IV because they thought she was dehydrated. On 13Mar2021, she went back to another hospital ER. She felt worse and her son came and got her and took her to the ER. They did a whole workup MRI of her head, x rays, blood work and everything. They didn't know what was causing it because it had it been over a week since her vaccine and they sent her home. She has been laying down and staying hydrated. She couldn't hardly get up and they asked her what has she done different and the only thing different was the vaccine. Everything listed on the risk factors [side effects] is how she is feeling. She was not hospitalized, they gave her medicine and told her to stay hydrated and sent her home and was told to follow up with her physician. She finally got an appointment for tomorrow (23Mar2021) with her physician. She can't drive because of the dizziness. All of her tests came back normal. They said her blood pressure fluctuated on 2021 but that is normal. Outcome of the injection site pain was recovered on 01Mar2021, of the difficulty breathing was recovering, of the headache, chills, fever, dizziness, weakness, and felt sick was not recovered, while of the remaining events was unknown.
70 2021-04-09 pain in extremity Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had dia... Read more
Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had diarrhea and vomiting (several times in a row).; simultaneously had diarrhea and vomiting (several times in a row).; headache; Slept all day; sore arm; chills; very tired; Fever about 100.5/temp now almost 101; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via unspecified route of administration in left arm on 23Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included prone to bronchitis with bad cold. Known allergies included strong reactions to oxycodone hydrochloride;paracetamol (PERCOCET), zolpidem tartrate (AMBIEN) and some anesthesias. Patient did not have COVID prior vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin, loratadine, ergocalciferol (VIT D) and multi-vitamin. The patient previously received first dose of BNT162B2 (lot number: EN6205) in left arm on 01Mar2021 09:30 AM for COVID-19 immunization. Evening of the shot on 23Mar2021 07:30 PM, patient experienced sore arm, chills, later and very tired. Fever about 100.5. Middle of night, about 16-17 hrs after shot (24Mar2021) awoke with nausea. Rose to go to bathroom and simultaneously had diarrhea and vomiting (several times in a row). Extreme tiredness and nausea. About 4:30 took 2 paracetamol (TYLENOL) and anti-nausea med. Passed out in bed on 24Mar2021. Woke about 11:30 AM. temp now almost 101, headache, paracetamol and more anti-nausea med. Slept all day until 10:45 PM 24Mar2021 fever normal, nausea gone, quite tired still. On 25Mar2021, patient was able to get up, still tired but so much better, stomach still queasy. Ate bit of toast, later, rice and applesauce. Bit of headache took paracetamol. Very difficult to fall asleep that evening (25Mar2021), awoke 26Mar2021 and fell so much better although stomach still a bit queasy. Treatment was received for all events. Patient had not tested COVID post vaccination. The outcome of events was recovering.
70 2021-04-17 pain in extremity, muscle spasms, feeling of body temperature change Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both... Read more
Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both upper and lower parts collapsed); Lower chest partial atelectasis or scarring in the lung bases bilateral; Beneath this area was a red circle where blood clotted or something; Wheezing; Shortness of breath; Swelling of the face; underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red; underneath the arm where the injection site was, a big red circle was noted and it was swollen; I would get hot and cold; I was sweating; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Fatigue; Pain in left elbow; goes to bathroom and bowel was not emptying the way it should; rib cage is going on the side of body noticed this thumping; Her lips were red; Throat was red; Been sick and just laying around; Her eyes were red; Cramp in left arm where site of injection; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; This is a spontaneous report received from contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 15Mar2021 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included lung issues and allergic asthma. Family history included brothers and sisters who died of lung issues and third sibling sister died many years ago due to allergic asthma. The patient previously took flu vaccine for immunization and experienced severe pain throughout her whole body. On 15Mar2021, patient received the first dose of Pfizer COVID-19 vaccine. Later on, that day when she got home after receiving the vaccine, underneath the arm where the injection site was, a big red circle was noted and it was swollen, beneath this area was a red circle where blood clotted or something, she would get hot and cold and take her clothes off because she was sweating but did not have fever, there was pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow. She goes to bathroom and bowel was not emptying the way it should. She also noted that her rib cage is going on the side of body noticed this thumping, lips and throat were red. She's been sick and just laying around, her eyes, under her nose and left elbow were red, had cramp in left arm where site of injection, and sharp pains were hitting her in her eye, thigh, chest, head, and the arm. Patient clarified that these symptoms began on 15Mar2021, the same day she received the Pfizer COVID-19 vaccine. On 23Mar2021, patient went to the ER and the findings were lower chest partial atelectasis or scarring in the lung bases bilateral and partial lung collapse (both upper and lower parts collapsed). At the hospital her temperature was 98.9 F on 23Mar2021, but 97.1F - 97.7F is her normal temperature. She went to the Pulmonary doctor also, but was getting a second opinion because she knew it could be life threatening. The pulmonary doctor made light of it saying they were just creases, like creases in pants. Patient said crease was a far cry from partial lung collapse on both bases and the Pulmonary doctor also said that it is in the upper part of the lung also. This scared her and made her think nobody cared. She did not know if she should provide the information because the doctor did not seem to believe that that her symptoms were coming from receiving the Pfizer COVID-19 vaccine. She guessed she should provide the information because Pfizer does research. She wanted to know how long do the side effects last and if she should take the second dose. The outcome of the events underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red, pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow, goes to bathroom and bowel was not emptying the way it should, rib cage is going on the side of body noticed this thumping, lips were red, throat was red, been sick and just laying around, eyes were red was not recovered; while unknown for the other events. Information on the lot/batch number has been requested.
70 2021-04-24 weakness My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; V... Read more
My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; Very weak and tired; This is a spontaneous report from a contactable consumer (reporting for herself). This 70-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration on left arm at a single dose on 04Feb2021 09:45 AM, for Covid-19 immunization. She Received second dose BNT162B2 (Pfizer Covid 19 vaccination, lot number EN6200) via an unspecified route of administration, on left arm at an single dose on 25Mar2021 for Covid-19 immunization. She was not pregnant at the time of vaccination. She had not received any other vaccine in four weeks. Medical history included type II diabetes, high blood pressure and pneumoconiosis. She was allergic to Chlorol Hydrate and Thimerasol. Concomitant medications included Metformin, Losartan HCTZ, Amlodipine, Zyrtec. On 09Mar2021 07:00 AM, the patient experienced a rash above her right knee, up my thigh, and knee pit, felt very weak and tired, her entire body experienced extremely severe body pain from upper neck down to feet. It got so bad that she could not walk, only took baby steps. It was stated that she would cry with hand on the wall with each baby step. On 12Mar2021, the patient went to the hospital emergency room and the patient was tested for Covid-19, blood test came out to be negative, results of SARS CoV-2, diagnostic radiologic EC EKG were unknown. She was treated with intravenous and pain medication. The outcome of the events of rash, felt very weak and tired, extremely severe body pain and could not walk was recovering. No follow-up attempts are needed. No further information is expected.
70 2021-04-28 weakness platelets have been significantly dropping/platelets were down to 4,000 units; platelets have been s... Read more
platelets have been significantly dropping/platelets were down to 4,000 units; platelets have been significantly dropping/platelets were down to 4,000 units; Really Weak; This is a spontaneous report from a contactable consumer (patient's daughter). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization. Medical history included ongoing thrombocytopenia (diagnosed 4-5 years ago). No concomitant medications. Family medical history included high cholesterol. The patient previously received the first vaccine dose of BNT162B2 on 23Feb2021 for COVID-19 immunization. No adverse event (AE) following prior vaccinations. The patient's daughter stated that the patient seemed like she was having an adverse reaction since her second vaccination. The patient's daughter said that this started after her mother received the second dose of the Pfizer-BioNTech COVID-19 Vaccine last 16Mar2021. The patient's platelets have been significantly dropping. The patient was rushed to the hospital because platelets were down to 4,000 units. The patient had thrombocytopenia but was managed well. The patient has Thrombocytopenia Disease and her hematologist recommended that she get the vaccine. Before the second vaccine, her platelets had been stable, not at normal range, but 78,000 to 71,000, which was normal for her. After the vaccine, the patient's platelet level has been significantly plummeting to single digits like 4,000 and then in a few hours shooting to 31,000 (in Mar2021). It was a consistent up and down for her. The patient was rushed to the hospital from her doctor's office and she was being admitted because her platelet level was down to 4,000 and she was getting a platelet transfusion. Ever since the patient got the vaccine, this started happening. Before, only once in a 3 year span, the patient's platelets dropped to 6,000 and now this is happening very often. The patient felt really weak for the last 2 days since 19Mar2021 (as reported) especially but it really started the same time as her platelets first dropped, so they took her to see the hematologist and fortunately they were able to get her in and did a complete blood count (CBC) and her platelets were down to 4,000 on 19Mar2021 (as reported). The treatment included Platelet Transfusions and was given steroid medication (they haven't received it yet but she was prescribed Promacta by Novartis). The patient has been in and out of the hospital 3 times within 2 weeks. Within a 2 week time frame, the patient has been there 3 times, 2 direct admit hospitalizations and 1 emergency room (ER) visit. She was rushed to the ER on either 05Apr2021 or 06Apr2021, but she was not admitted because when they took her labs at the doctor, her platelets were 4,000, but when they were rechecked in the ER they were 38,000 so the released her because it came up and was over 30,000. The patient was admitted to the hospital from her doctor's office on 09Apr2021 and released 10Apr2021. She was admitted to the hospital again on 14Apr2021. Event occurred after the second vaccine dose. The patient had a visit to physician's office for a couple of times. The outcome of the events was not recovered. Information on Lot/Batch number has been requested.
71 2021-01-12 numbness Approximately 22 hours after I received the first vaccine my left arm from the elbow down to my hand... Read more
Approximately 22 hours after I received the first vaccine my left arm from the elbow down to my hand went numb. No tingling just no feeling. Could not hold anything and no strength in that arm and hand.
71 2021-01-13 unresponsive to stimuli 71yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, VS taken at 10... Read more
71yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, VS taken at 10am, B/P 99/60, O2 sats, 95% (trach w/O2). At 11:30am, Patient showed no s/sx of distress, A&Ox3. At 11:50am, a nurse went to perform a COVID test and assessment (the facility is experiencing an outbreak), and found the patient unresponsive on the bathroom floor. CPR was immediately started; no shock advised per AED; 12:15pm EMS arrived and took over. At 12:38pm, EMT called time of death.
71 2021-01-14 pain in extremity Sore arm, fatigue
71 2021-01-15 cold sweat 1/15/2021, 8:15 AM Approx. 10 minutes after arising, experienced dizziness, nausea, unwell feeling,... Read more
1/15/2021, 8:15 AM Approx. 10 minutes after arising, experienced dizziness, nausea, unwell feeling, cold sweat. Lasted approx. 20 minutes. Resolved after lying down..
71 2021-01-17 pain in extremity Qualifier: I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm ... Read more
Qualifier: I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm on 1/12/21. When I woke up on 1/13/21, I was very sick. I felt like I had a severe, very bad, horrible flu. I didn't get out of bed until 5pm that evening. No fever. No body or joint aches. Just extreme, overwhelming fatigue and feeling flu-y. This phase lasted about 24 hours. (my right am also hurt, but that was minor) I have a severe case of Sjogrens, a systemic autoimmune disorder. My most debilitating Sjogrens symptom is overwhelming fatigue. If I weren't retired, I would be qualified as disabled. Handicapped tag, etc. Since the vaccination, my Sjogrens has "flared." I feel terrible, exhausted, can't do anything. I have cancelled everything. All I can do is sleep, and feed the cat. I am directly connecting this Sjogrens flare to the vaccine. When I'm in a flare this bad, I usually take a course of prednisone. I have not done this because I don't want to modulate my immune system while it is building covid antibodies. I can't wait for the 2nd vaccine on 2/2/21!
71 2021-01-18 pain in extremity Minor soreness in muscle of left calf
71 2021-01-19 hot flush, tremor I felt fine while monitored in the parking lot for 15 minutes following injection. On my way home at... Read more
I felt fine while monitored in the parking lot for 15 minutes following injection. On my way home at 25 minutes post injection I had an over-all body wave-type feeling (somewhat similar to a sustained hot-flash) and over-all disconcertingly odd feeling. This lasted about 4 minutes and was followed by shakiness that lasted about 5 minutes (total time a bit less than 10 minutes). Took my bp, pulse, O2 as soon as I got home (approximately 5 minutes post symptoms) and the readings were fine.
71 2021-01-19 feeling hot Pt reported feeling some nausea approx 10 minutes post injection, along with feeling hot. Pt denies ... Read more
Pt reported feeling some nausea approx 10 minutes post injection, along with feeling hot. Pt denies vomiting, denies shortness of breath, rash/hives, difficulty swallowing and other symptoms. Pt reports a single reaction to an antibiotic in the past, denies Hx of vaccine reactions. Pt states she feels cooler after removing two of her three long sleeve layers. Nausea treated with 8mg ODT ondansetron, with noted relief.
71 2021-01-20 weakness, pain in extremity Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day a... Read more
Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day after vaccine; fatigue and weakness on day 2 after.
71 2021-01-20 weakness Tightness in chest , Hives, weakness, required visit to E.R. Given IV Benadryl Pepcid, prednisone
71 2021-01-20 discomfort couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a ... Read more
couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 10Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving her Covid19 vaccine on Sunday 10Jan2021, reports feeling "heavy", chills, and a headache on Sunday 10Jan2021. On 11Jan2021 Monday afternoon she reports that she "couldn't remember the 4-digit passcode to my phone" or her address, but that her memory came back "in a second". The event couldn't remember passcode for the phone or her address was reported as recovered and unknown for the other events. Information on the Lot/Batch number has been requested
71 2021-01-20 tenderness slight left arm tenderness the day after vaccine
71 2021-01-21 tingling 20 minutes after the injection my face around my right eye and down ward started to swell and tingle... Read more
20 minutes after the injection my face around my right eye and down ward started to swell and tingle. within the hour it went away.
71 2021-01-21 muscle spasms, burning sensation Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. ... Read more
Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. Stomach was queasy. Unable to drink coffee. Tried to push fluids and tried to just eat bland foods. Would wake up sporadically but was unable to awaken enough to watch an entire TV show. Pretty lethargic and brain fog. Was able to wake up a little more on Wed 1/20 but still had the queasy stomach. Started getting Headache and Eye pain and severe upper leg and lower back burning & cramping, I tried taking tylenol which helped a little. By Thursday the pain was worse. I was still tired only walking helped the pain. It got worse if I sat down and extremely bad if I laid down to try to sleep. It's Friday morning & I am planning to go to med check this AM. Symptoms still ongoing
71 2021-01-24 burning sensation, numbness Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: fa... Read more
Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: face swollen, blotchy, numb eyes swollen, sore sockets, upper lip puffed out, burning face feel, asthma
71 2021-01-24 muscle twitching, speech disorder Extremely unusual pain at injection site, (compared to any other past injections) generally achey, ... Read more
Extremely unusual pain at injection site, (compared to any other past injections) generally achey, headache, occasional waves of nausea, fever 100.4, fatigue (stayed in bed most of the day). There was one occasion where my left hand had a strange involuntary "twitch". I only mention that because on Saturday (1/23/21) i had a few episodes of speech difficulty (words "not coming out right")
71 2021-01-25 tremor 1:45 warmth of entire left arm and felt anxious, felt elevated heart rate and shakey b\p 190/90 hea... Read more
1:45 warmth of entire left arm and felt anxious, felt elevated heart rate and shakey b\p 190/90 heart rate 90 2pm 176/72 heart rate 90 sat up 160/90 gave OJ to drink released 2:30 178/88 heart rate 80 Instructed to seek medical attention if further problems. Was walked to car
71 2021-01-25 one side paralysis Began experiencing left sided weakness, Evaluated in ER, Medivac'd to other facility for stroke
71 2021-01-25 tingling, numbness light headed; tingling and slight numbness (like coming out of Novocain) in left side of face predom... Read more
light headed; tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area.; tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1283), via an unspecified route of administration at Left arm on 15Jan2021 08:15 at SINGLE DOSE for COVID-19 vaccination. Medical history included osteoporosis and gastroesophageal reflux disease (GERD). The patient was not pregnant. The patient was allergic to Codeine and derivatives. Concomitant medication in two weeks included denosumab (PROLIA), piroxicam (PAXIL), omeprazole, clarithromycin (CLARITIN). The patient previously took codeine and experienced drug hypersensitivity. On 15Jan2021 08:30, within 15 min after vaccination the patient became light headed, then tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area. Light headed went away within another 15 min and numbness within another 45, but the latter came back in the left cheek and forehead in approximately four hours. No treatment received for the events. No Covid prior vaccination, no Covid tested post vaccination. The outcome of the event light headed was recovered on 15Jan2021, of other events was not recovered.
71 2021-01-26 pain in extremity Mild fever, nausea headache, extreme fatigue, muscle ache, stuffy nose, sore throat, sore arm
71 2021-01-26 one side paralysis, facial paralysis Patient is a 71-year-old female with PMH of type 2 diabetes, hypertension, hyperlipidemia, cataracts... Read more
Patient is a 71-year-old female with PMH of type 2 diabetes, hypertension, hyperlipidemia, cataracts, glaucoma who was transferred from Medical Center as a stroke code after she presented there for right-sided weakness, facial droop and visual changes. Patient was given TPA in the past she was within window and she was then transferred here for further management. Patient's symptoms continue to resolve. She was admitted in the ICU and managed by neuro critical care and neurology. Further imaging including CTA head and neck, MRI brain did not reveal any stroke. An assessment of small vessel disease was made which likely resolved after TPA was given. Patient was assessed by PMR and PT/OT and deemed safe to go home with family care and no restrictions. Echo, telemetry and EKG showed no signs of cardiac involvement. Patient was started Plavix x21 days and chronic baby aspirin. She was also started on Crestor 20 mg daily. Patient is to follow-up with neurology in 3 months as she got TPA. She will also follow-up with her PCP on discharge.
71 2021-01-26 tingling Periodic Tingling sensation like electric impulses shooting from injection area in a line up arm, ac... Read more
Periodic Tingling sensation like electric impulses shooting from injection area in a line up arm, across shoulder and up neck about ear level; Low back/ hip pain I haven?t had before, especially at night turning over in bed. Self-massage, change position
71 2021-01-27 pain in extremity Right arm killing her through the night; Little Achy; Headache; This is a spontaneous report from a ... Read more
Right arm killing her through the night; Little Achy; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (BNT162B2 also reported as Pfizer COVID Vaccine, lot EL3247), intramuscular in the right arm on 13Jan2021 18:00 at SINGLE DOSE for Covid-19 immunisation (reported as prevention for age group). She received the vaccine in a hospital. Medical history included a Covid-19 patient on Mar2020, hypothyroidism and normally had headaches. No other vaccines taken prior to vaccination. There were no concomitant medications. On 13Jan2021 03:00, she had arm pain that was killing her through the night. She was a little achy, had a headache, but no fever. The outcome of events was recovering.
71 2021-01-28 burning sensation developed a cluster type headache that lasted all night/severe cluster headache; developed pinpoint ... Read more
developed a cluster type headache that lasted all night/severe cluster headache; developed pinpoint itching all over her body/mild itching today 'like when a nerve lights up'; she felt her left outer ear was burning until around 22:00 at night; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL0142 and expiry date:Mar2021) , via an unspecified route of administration on 13Jan2021 16:15 at a single dose in left arm for covid-19 immunization. There were no medical history and concomitant medications reported. She states that she had the first dose of the vaccine on Wed 13Jan2021 at 16:15 together with her husband, right after receiving the dose on left arm she felt her left outer ear was burning until around 22:00 at night and was milder the next day. She states that last night 14Jan2021 around 20:00, she developed a cluster type headache that lasted all night, she took ibuprofen (ADVIL) and around 22:00 the same night she developed pinpoint itching all over her body. She reported she still has some mild itching today 'like when a nerve lights up' and still has a 'little bit of a headache.' She wants to know if these were common side effects. The outcome of the event burning sensation recovered on 14Jan2021, while cluster headache and itching were recovering.
71 2021-01-28 muscle spasms fever, chills, headache, muscle spasms, difficulty walking across the room, dizziness, fatigue, bra... Read more
fever, chills, headache, muscle spasms, difficulty walking across the room, dizziness, fatigue, brain fog
71 2021-01-29 tremor 11 hours after injection SHAKING CHILLS, teeth chattering to the extreme. 101.5 fever throughout the... Read more
11 hours after injection SHAKING CHILLS, teeth chattering to the extreme. 101.5 fever throughout the night. Fatigue
71 2021-01-29 tenderness Lymphadenopathy, possibly. Tenderness under armpit and in underside of arm. Started on day 3 follo... Read more
Lymphadenopathy, possibly. Tenderness under armpit and in underside of arm. Started on day 3 following the shot. Has continued until now (day 12). Tenderness has lessened in my lower arm, but continues in my upper arm and under armpit.
71 2021-01-29 burning sensation, tingling Tingling lips, tongue, face. Tongue numbness and burning sensation
71 2021-01-30 pain in extremity This was my second dose. After the first dose, I only had a sore arm. This time, about 12 hours afte... Read more
This was my second dose. After the first dose, I only had a sore arm. This time, about 12 hours after receiving the shot, I began to feel aches and pains (like a cold was coming on). During the night I had some chills and the next day I was very achy and very tired. I napped about 4 hours during the day and was asleep by 8p.m. and slept for 12 hours. The next day (second day after the shot), the aches receded but I was still very lethargic for about another 8 hours. I began to feel 'normal' by evening and am felling OK today (third day after the shot). I did drink a lot of water during the whole time as I felt very thirsty (and I am normally a big water drinker!) I also had no appetite until this morning.
71 2021-01-30 flushing Very fluish- aches, pains, very bad headache, couldn't get out of bed for 36 hours. After 48 hours ... Read more
Very fluish- aches, pains, very bad headache, couldn't get out of bed for 36 hours. After 48 hours I am just very tired and having sporadic shooting pains in my head.
71 2021-01-31 tingling Site of injection and arm become blotchy, red, rash, swollen 1 hour after injection.she reports she ... Read more
Site of injection and arm become blotchy, red, rash, swollen 1 hour after injection.she reports she got a sensation ?like she was going to have shingles-tingling? shortly after her arm that she received the vaccine in was blotchy/rash from site down to wrist and entire extremity became swollen. It went away by itself by the next day. No other issues. She proceeded to call the CDC and her PCP.
71 2021-02-01 pain in extremity sore arm, nausea.
71 2021-02-03 migraine, tremor Eye twitch with visual shaking Migraine headache
71 2021-02-03 feeling hot Feeling some nausea; Feeling hot; This is a spontaneous report from a contactable pharmacist. A 71-y... Read more
Feeling some nausea; Feeling hot; This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 29Dec2020 (12:45) at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 29Dec2020 (13:00), the patient was feeling some nausea; and was feeling hot. The patient had received an unspecified treatment for 'feeling hot'; and had received ondansetron for 'nausea'. The outcome of the events, 'feeling some nausea' and 'feeling hot', was recovered on an unspecified date. The patient was not tested for COVID-19 post-vaccination.
71 2021-02-03 muscle spasms, weakness, cold extremities Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps,... Read more
Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps, severe weakness.
71 2021-02-03 tremor, feeling cold Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaki... Read more
Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner. On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.
71 2021-02-04 tenderness Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on ... Read more
Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on right side (like a canker sore)
71 2021-02-04 flushing Patient felt warm, flushing from waist to feet; BP, pulse, respiratory rate, and O2 sat: 132/69, 78,... Read more
Patient felt warm, flushing from waist to feet; BP, pulse, respiratory rate, and O2 sat: 132/69, 78, 20, 99%. Felt better after 15 minutes.
71 2021-02-04 tingling, burning sensation Tingle in left side of face, chin, and Burning in Back from Right arm to left arm, Treatment, with D... Read more
Tingle in left side of face, chin, and Burning in Back from Right arm to left arm, Treatment, with Doxycline and Predisone, second day some re-leaf.
71 2021-02-04 pain in extremity about 14 hrs after receiving the second vaccine I had extreme chills, severe body aches and headach... Read more
about 14 hrs after receiving the second vaccine I had extreme chills, severe body aches and headache, pain in my eyes, moderate arm pain and fatigue. I began feeling better about 10 hrs later but continued to feel fatigued the rest of the day and had body and head ache a couple more days. I had had covid in Sept 2020 and felt worse those 10 hrs than when I had covid.
71 2021-02-04 feeling cold cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea;... Read more
cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea; feeling freezing cold; chills; ache; cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration at left arm on 19Jan2021 08:15 at a single dose for COVID-19 immunization. She was sick (COVID symptoms) all Dec2020 when she was with her sister who had COVID-19. She does not know for sure that she had COVID 19 because she was never tested. She recovered from that illness about two weeks before getting the Pfizer COVID 19 vaccine first dose. The cough was all gone before she had the Pfizer COVID 19 vaccine. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient had the vaccine on 19Jan2021, two days ago and had not had a problem. She left there and went to the gym for 1 hour afterwards. Then yesterday morning she woke up and has been sick ever since with a cough and chills. She never tested positive for COVID but she was with her sister who had it during Dec2020. She had a cough similar to the one she had in Dec2020 when she was quarantined for COVID symptoms. She was not expecting anything, but it says you can have side effects if you have had COVID-19 so she was calling in about that. On 20Jan2021 she woke up at 02:00 in the morning with a cough; injection site pain which was not sore before; headache; muscle pains, chills; joint pain; fever, but not a high fever; feeling freezing cold; and nausea. She reported 'cold, chills, fever, ache'. She felt a little bit better today on 21Jan2021. She was scheduled to receive the second dose on 15Feb2021 at 08:15. The patient would like to know whether her history of COVID symptoms from Dec2020 may have aggravated her post-vaccination symptoms. The patient would like to know whether there have been other reports of similar post-vaccination as hers. The outcome of the events cough, injection site pain, headache, fever and feeling freezing cold was recovering; event muscle pain, joint pain and nausea was not recovered; event chills was recovered on 21Jan2021; and unknown for the other events.
71 2021-02-04 slurring, inability to speak hospitalization, intermittent drooling, difficulty finding words (like a broca's aphasia), slurring ... Read more
hospitalization, intermittent drooling, difficulty finding words (like a broca's aphasia), slurring of words, and absent seizure
71 2021-02-05 pain in extremity Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light head... Read more
Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light headed, extremely tired, sore arm, joint aches Spent the morning in bed and the afternoon on the couch. Temp 99.8 Took tylenol several times during the day and that night. By the following morning most of the symptoms had disappeared with a moderately sore left arm still present.
71 2021-02-05 flushing Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red ... Read more
Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red flushing to the skin on the face and left neck, shoulder & hip pain. BP initially was 182/98 which is elevated for me. Felt disoriented & very unwell. Over the next few days, low BP was noted @90/62, pulse 58. This occurred intermittently.
71 2021-02-07 tingling APRN was notified of possible reaction to COVID-19 vaccine (lot # EN9581, exp. 5/31/21) at 2:18 pm. ... Read more
APRN was notified of possible reaction to COVID-19 vaccine (lot # EN9581, exp. 5/31/21) at 2:18 pm. Patient initially complained of tongue pain and a headache; she then began to develop throat tightness and her voice began to change and she began to clear her throat and developed a "tingling" sensation. EMS was called at 2:25pm. First dose of epinephrine 0.5mg was administered IM right anterolateral thigh at 2:25pm, the sensation of her throat closing persisted at 2:30pm and another dose was administered of epinephrine 0.5mg was administered IM left anterolateral thigh at 2:30pm. EMS arrived and patient left in ambulance at 2:35pm. Vitals: 2:20 pm BP 110/64 HR 85 O2 sat 97% 2:25 pm BP 102/64 HR 93 O2 sat 95% 2:30 pm BP 112/60 HR 87 O2 sat 95% 2:32 pm BP 120/82 HR 90 O2 sat 98%
71 2021-02-07 tremor, numbness, feeling hot, flushing Flushing, numbness left hand and fingers, quivering and burning in chest, numbness and tingling of l... Read more
Flushing, numbness left hand and fingers, quivering and burning in chest, numbness and tingling of lips with metallic taste. Blood pressure 160/100, Heart rate 125-130. O2 saturation on room air 96-98%. Patient transported to Emergency Room via private vehicle. Patient declined ambulance transport.
71 2021-02-07 numbness, facial paralysis Patient diagnosed with Bells Palsy, mild case. Symptoms include numbness and pain on the left side o... Read more
Patient diagnosed with Bells Palsy, mild case. Symptoms include numbness and pain on the left side of the patients face along the facial nerve. Patient also experienced left sided drooping of her cheek, lips and eye.
71 2021-02-07 bell's palsy, facial paralysis Symptoms: Pain in back of neck, right side facial paralysis, swelling, right eye not closing, un ... Read more
Symptoms: Pain in back of neck, right side facial paralysis, swelling, right eye not closing, un even smile. Went to ER. Diagnosis was Bell's Palsy. Treatment included a course of prednisone and Valtrex and lubricating eye drops as needed.
71 2021-02-08 tremor, flushing Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is h... Read more
Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is high for her; Felt heart palpitations and pressure in her chest; Felt heart palpitations and pressure in her chest; Facial flushing, redness; Facial flushing, redness; Lips swollen and numb; Lips swollen and numb; Left arm stiffness; This is a spontaneous report from a contactable consumer reported for self. This 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 12:30 on Arm left at single dose (lot number: EL8982) for Protection from COVID. Medical history included diabetes, slightly elevated blood pressure, taking drops under her tongue for her 21 environmental allergies, clarified product as sublingual immunotherapy, had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with "met." And allergy to antibiotic. Concomitant drug included Sublingual immunotherapy, metformin at 500 mg and cetirizine hydrochloride (ZYRTEC). Past drug history included had Drug hypersensitivity to Neurontin, Detrol, Sulfur, and Neuropherntin. The patient experienced facial flushing, redness, and her lips felt like she had a Novocain shot on 22Jan2021. Her lips are still kind of numb. Can't feel her lips when she bites down on them. Believes reaction was fairly immediate. Sitting there for 15-20 min. Could feel a little facial flushing. Went home because (name withheld) is 45 minutes away from her house. By the time she got home was very flushed. Lips were getting more swollen and numb on 22Jan2021. Had an Epinephrine injection UPS Auto injector 0.3 mg, NDC: 49502 10201,Lot: 9FM783, Exp: Jun2021, Dose: injected one time in the middle of her right thigh and used it. Went to the ER. Had blood work and an EKG done. Was kept for five hours in ER. Had a chest x-ray. Blood pressure was 183 over something, which is high for her on 22Jan2021 that is controlled with medication. Experienced Hands shaking and looked like she has Parkinson's on 22Jan2021. Only lasted for a short time. Put on Prednisone for five days and told to see primary physician. Can't get into primary physician until Wednesday. Felt heart palpitations and pressure in her chest. Can't separate if it was the COVID-19 Vaccine or her nerves. She experienced Left arm stiffness on 22Jan2021. AEs require a visit to ER, was discharged from ER. Lab data on 22Jan2021 included Two sets of blood work separated by 3-4 hours: Unknown Results, Chest X-ray: Unknown Results, EKG: normal; on unknown date had a colonoscopy the day before the COVID-19 Vaccine: Unknown Results; Treatments were received for the events. Outcome of the events was unknown.
71 2021-02-08 inability to speak She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both ar... Read more
She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both arms, the crown of her head, and on her scalp; Pfizer covid vaccine: nausea; Pfizer covid vaccine: chills; Pfizer covid vaccine: hurting at the injection site; Pfizer covid vaccine: headaches/on and off headaches; She cannot speak this morning; Pfizer covid vaccine: vomiting; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL8982, expiry date: 31May2021) intramuscular injection in right upper arm on 19Jan2021 10:00 at single dose for COVID-19 immunisation. Her second dose is scheduled on 10Feb2021. Medical history included stage 4 metastatic breast cancer. There were no concomitant medications. The patient previously took Ibrance for stage 4 metastatic breast cancer and experienced broken out in terrible rash. She is taking Ibrance for cancer, she has been taking it for a while. The past few weeks she has broken out in terrible rash. She went to a dermatologist that stated the rash was from Ibrance. She cannot speak this morning (Jan2021). Her doctors are speaking to each other and she is being told not take Ibrance by the dermatologist and to continue taking from her oncologist. Reports she had a pathology report and it showed her skin eruptions she is having is from Ibrance. She clarifies that her terrible rash is up and down both arms, the crown of her head, and on her scalp. She took the first dose of the COVID-19 vaccine a couple of weeks ago. She is having quite a bunch of side effects from the injection. The side effects she is experiencing after the COVID vaccine are nausea, vomiting, chills, hurting at the injection site which is not terrible, and on and off headaches. Events did not require a visit to emergency room or physician office. Nausea started 3 days after the receiving the vaccine on 22Jan2021. Vomiting is still ongoing on and off and started about a week and half after receiving the vaccine (Jan2021). Chills started right away and she still has the chills. It has not changed. The chills started maybe a day after receiving the vaccine (20Jan2021). Hurting at the injection site started the day after (20Jan2021) and lasted for two or three days and is still ongoing, reports it goes on and off. Reports the hurting at the injection site is not terrible. Headaches started a day or so after receiving the vaccine (20Jan2021) and is still ongoing, on and off. Reporter seriousness for events nausea, vomiting, chills, hurting at the injection site, headaches were reported as medically significant. She is currently taking Ibrance since her oncologist told her not to stop taking Ibrance. The dermatologist said her rash is related to Ibrance. When querying causality she reported that she is not sure because she has been taking Ibrance for a while. She confirms the rash started after receiving the COVID vaccine. Events outcome of nausea, vomiting, chills, hurting at the injection site, headaches was not recovered (nausea and vomiting was reported as worsened), while for others was unknown. Relatedness of drug Pfizer COVID vaccine to events for nausea, vomiting, chills, hurting at the injection site, headaches were reported as related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
71 2021-02-09 pain in extremity I had a mild headache for 2 days; sore arm.; Had some fatigue for 2 days.; This is a spontaneous rep... Read more
I had a mild headache for 2 days; sore arm.; Had some fatigue for 2 days.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EL3248, Expiry date: unknown) via an unspecified route of administration on right arm on 23Jan2021 at 08:45 AM at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, Sjogren's syndrome, fibromyalgia and hypothyroidism. The patient has no Allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included methotrexate, atorvastatin and levothyroxine. The patient stated she had a mild headache for 2 days, sore arm and had some fatigue for 2 days on 23Jan2021 at 18:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and also since the vaccination, the patient was not been tested for COVID-19. Therapeutic measures were taken as a result of the events had a mild headache for 2 days, sore arm and had some fatigue for 2 days which was Tylenol and rest. The outcome of the events headache and fatigue was resolved on 25Jan2021 while outcome for sore arm was resolved on an unspecified date in Jan2021.
71 2021-02-09 numbness had like sort of a hard time breathing; got really weird smell; lips and her tongue were all this ki... Read more
had like sort of a hard time breathing; got really weird smell; lips and her tongue were all this kind of swelled and then like it was steamed; lips and her tongue were all this kind of swelled and then like it was steamed; her arm, both of her arms went numb; could not go to sleep; This is a spontaneous report from a contactable consume r(patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose (Lot # EL8982) for covid-19 immunisation. Medical history included stated, the only thing was got the susceptible to blood clots, had that gene so that is one of the reasons took the vaccine other than that did not take any meds. The patient didn't even take any blood thinners because did not need them." (not clarified further). No concomitant therapy included. The patient did not know if it is the vaccine but she got really weird smell and then her lips and her tongue were all this kind of swelled and then like it was steamed. The patient stated, "In the tongue and my lips, it was like when you get chilli on them and a distinct type of smell. " And then her arm, both of her arms went numb and she had like sort of a hard time breathing. Now, that it went away but she just waited and waited and it lasted almost in the most of the night and then she could not go to sleep but it was something she had never had before and it was very strange. She did not know if you have that kind of reaction from people or you know if it has come up but she thought she better report it because she had not had my second dose yet. She had to get the second dose on 09Feb. No treatments were received. Outcome of the events was recovering.
71 2021-02-14 feeling cold The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and bet... Read more
The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; next day she felt fine, cold but it's cold; chills; headache; First dose was on 05Jan2021/ Received the second dose on 22Jan2021; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration in left arm (by injection) on 22Jan2021 17:00 (also reported as 16:30) at a single dose for COVID-19 immunization. Medical history included allergic to yellowjacket (anaphylaxis) and bee venom. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient experienced chills and headache on 23Jan2021, next day she felt fine, cold but it's cold on 24Jan2021, itching and a rash on his right arm up to her shoulder and between her legs and small bumps on 25Jan2021, the rash now is getting little bumps on an unspecified date. Patient received Pfizer-BioNtech Covid-19 vaccine on Friday 22Jan2021 around 4:30PM (as reported). On Saturday she experienced chills and headache, next day she felt fine, cold but it's cold in the city, she didn't take anything (Tylenol). Last night she started to get itching and a rash on his right arm up to her shoulder and between her legs and small bumps. She would like to know if this side effects have been reported for the vaccine. The patient reported she is getting a little concerned. She had her 2nd dose of the Pfizer COVID vaccine on Friday, 22Jan2021. She had the side effects that Pfizer submitted in the brochure. She had them starting on Saturday. She had chills and a headache. The headache left her by Sunday morning. She now she has a rash that started last night in her thighs between her legs. Then this morning it is on her arms in the folds. She does not know if that is normal. She is wondering if this is a normal side effect and what to do about it. She has had anaphylaxis from yellow jackets before. She hopes she does not go that direction. Received the second dose on 22Jan2021 at 5 pm. The chills is hard to tell if she still has it as it is cold in the city. She took Tylenol for her headache. She used anti itch cream after she showered. The rash now is getting little bumps. First dose was on 05Jan2021 (LOT: EL0142). No expiration date or NDC for first or second dose is written on her vaccination card. She thought maybe it was her detergent, or bleach, but that is not it. Therapeutic measures were taken as a result of headache which included Tylenol and itching which included anti itch cream. The outcome of the event headache was recovered on 24Jan2021, of event itching and a rash on his right arm up to her shoulder and between her legs and small bumps was not recovered, while for the other events was unknown.
71 2021-02-17 cold sweat This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (no... Read more
This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (not pregnant) received first dose bnt162b2 (BNT162B2 also reported as product COVID 19 brand Pfizer, lot/batch number expiry date not reported), via an unspecified route of administration in left arm on 05Feb2021 00:45 at SINGLE DOSE for Covid-19 immunisation. Medical history included blood pressure abnormal and chronic kidney disease. She did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram, diltiazem, amlodipine, calcitriol and iron. The patient experienced cold sweat, slight fever and chills (all non-serious) on 06Feb2021 03:00, no treatment. The outcome of events was unknown. Information on the lot/batch number has been requested.
71 2021-02-17 nerve pain passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chil... Read more
passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chills-shivers; Bad headache; Dizziness; Couldn't sleep; Neuropathy pain in hip/groin; This is a spontaneous report from a contactable consumer reporting for herself. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809 and expiry date unknown) on 05Feb2021 08:30 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included known allergies to statins. The patient had received first dose of BNT162B2 (lot number EL3248) on 15Jan2021 16:00 for COVID-19 immunization (vaccine location=Left arm). The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included gabapentin (GABAPENTIN), fish oil (FISH OIL), zinc (ZINC), cyanocobalamin (VITAMIN B 12), iron (IRON). No other vaccine received in four weeks. The patient experienced adverse events from 05Feb2021 at 20:30. She experienced chills-shivers, had bad head ache, dizziness, couldn't sleep, intense neuropathy pain in hip/groin when got out of bed and then passed out when went into bathroom at 5 am (06Feb2021), cut chin when fell. She felt dehydrated. Cold marble floor felt good as she had sweats, so she just layed there awhile. Her husband came to her rescue with water and cold compress for her head. She received lots of liquids and rest. She had good night's sleep on 06Feb2021. The outcome of the events was reported on 07Feb2021 as recovered.
71 2021-02-18 flushing Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; re... Read more
Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
71 2021-02-21 weakness, pain in extremity Feb 11, sore arm for one day; Feb 17 started with muscle and joint pain, especially tender right kne... Read more
Feb 11, sore arm for one day; Feb 17 started with muscle and joint pain, especially tender right knee and overall not feeling well; Feb 18 felt lightheaded and weak with standing through out the day; Feb 19 weakness and lightheaded much worse, had several episodes of vomiting and become too weak to stand; went to ER
71 2021-02-21 tremor Fever, chills, shaking,body aches, headache, dizziness, fatigue
71 2021-02-22 cold extremities, feeling cold 4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, he... Read more
4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, headache, cold feet/hands & back, light headness -feeling might pass out, sneezing, coughing, extreme fatigue,nasal discharge, loss of taste, nausea, stomach ache, knots in throat (very painful) & swelling.
71 2021-02-22 pain in extremity, facial pain Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating h... Read more
Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating head ache and facial pain not relieved by #2 50mg Ultram every 4 to 5 hrs, lethargy, chapped lips and cold sore. February 23rd most symptoms gone except lethargy and cold sore.
71 2021-02-23 pain in extremity 10 days later arm got red; soreness to her arm; This is a spontaneous report from a contactable cons... Read more
10 days later arm got red; soreness to her arm; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has a question about the COVID-19 vaccine. She stated that she thought she had a simple question, and she called the COVID hotline, and the CDC and they just keep bouncing her around. She said she had her first dose of the vaccine on 16Jan2021, and wasn't bothered by it, she had just a bit of soreness when she touched her arm (unspecified date in Jan2021), but 10 days later, on 26Jan2021, her arm got red, so she is wondering if this could be a delayed reaction. She stated that she is not having bad effects, she is just wondering why it would pop up after so many days. Outcome of the events was unknown. Information on the lot/batch number has been requested.
71 2021-02-23 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable consumer, reporting for herself. A 71-... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer, reporting for herself. A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 27Jan2021 15:15 at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Department. Medical history included hypertension (HTN), gastrooesophageal reflux disease (GERD), total hysterectomy and osteoarthritis, all from an unknown date and unknown if ongoing. The patient was not pregnant. There were no known drug allergies. Concomitant medication included celecoxib (CELEBREX), omeprazole magnesium (PRILOSEC), estradiol (ESTRACE), metoprolol succinate (TOPROL XL) and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION). It was reported that the patient experienced right sided neck pain which began a couple of days after vaccination on 06Feb2021 07:00. On 05Feb2021, her right eye was twitchy. On 06Feb2021, the right side of her face felt swollen. It felt like when you go to the dentist and get numbed. She tried drinking a liquid and it ran out of the right side of her mouth. She went to urgent care and they sent her to the emergency department. She had a CAT-scan, MRI and blood work done which all came back normal. Her right eye was not closing all of the way and they diagnosed her with Bell's Palsy on 07Feb2021. She was prescribed a course of prednisone and Valtrex. She has continued to have right-sided facial paralysis and her right eye will not close. She had had severe pain in her right eye and had to tape it shut to sleep and often during the day because it dries out. She was using Systaine eye drops every couple of hours and an eye gel at night. She was concerned about getting the second dose because she does not want this to get worse. There were no other vaccines in four weeks. There was no COVID prior to vaccination and was not COVID tested post vaccination. The outcome of the event was not recovered.
71 2021-02-23 numbness Chest pain and pressure; Chest pain and pressure; Numbness on left jaw, arm and hand; This is a spon... Read more
Chest pain and pressure; Chest pain and pressure; Numbness on left jaw, arm and hand; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in right arm on 23Jan2021 13:45 at single dose for COVID-19 immunisation in facility type other. The patient's medical history included asthma, unspecified auto immune, sickle cell trait, reflux. The patient have allergies to medications, food, or other products. Concomitant medications included nifedipine (CELEBRATE) at 200 mg, mirtazapine at 7.5 mg, vitamin b12, ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 23Jan2021 04:00 AM, the patient experienced chest pain and pressure, numbness on left jaw, arm and hand. The adverse events result in emergency room/department or urgent care. The events were considered as non-serious by the other healthcare professional. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
71 2021-02-23 night sweats Chills with violent shivering starting second night after vaccine and continued for 3 nights. Dren... Read more
Chills with violent shivering starting second night after vaccine and continued for 3 nights. Drenching night sweats overnight began the 3rd night and is continuing now but lessening slightly in degree. Headaches. Muscles ache and stiffness particularly in legs. Slight loss of balance from time to time. Loss of appetite. Rash on chest possibly caused by sweating at night. Increased severity when bruised.
71 2021-02-23 difficulty speaking Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have... Read more
Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events "have been sick ever since", "flu like symptoms", headache, nausea, extreme fatigue and "hoarse" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients
71 2021-02-23 tingling, numbness Got nervous feeling; Allergic reaction to bee sting; rash of heat from her neck up to her head; noti... Read more
Got nervous feeling; Allergic reaction to bee sting; rash of heat from her neck up to her head; noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow/still having the swallowing; Congested head, head felt congested, not like pressure; Fingertips a little numb and tingling; Fingertips a little numb and tingling; This is a spontaneous report from a contactable consumers (one is the patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269), via an unspecified route of administration on 03Feb2021 at 10:40 at a single dose on the right arm for COVID-19 immunization, ibuprofen (manufactured by other company, strength: 200 mg, lot number: 7AE1784B, expiry date: Nov2018), oral from an unspecified date and ongoing at 400 mg, as needed for an unspecified indication, hydrochlorothiazide (strength: 25 mg), oral from an unspecified date and ongoing at 25 mg, once a day (about 8am) for high blood pressure, and valsartan (strength: 160 mg, expiration date: 11Nov2021), oral from an unspecified date and ongoing at 160 mg, once a day (about 8am) for high blood pressure. Medical history included ongoing high blood pressure. The patient's concomitant medications were not reported. The patient previously took flu shot about 15-20 years ago for immunization and experienced swelling. On 03Feb2021, patient received the vaccine. When going home, she noticed all of a sudden a rash of heat from her neck up to her head. Figured it was not a problem to have a little reaction and thought nothing of it. She had a cup of coffee this morning and not a lot of water, so she started drinking water and had 3 bottles. After the heat passed she noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow. She is still having the swallowing and is continuing to drink water even at home. She also congested head, head felt congested, but not like pressure. She does not get headaches so she guesses she is getting this instead of a headache. She noticed her fingertips feel a little numb and tingling, but overall feels okay. She mentioned that on an unspecified date, she just got this nervous feeling and had allergic reaction to bee sting. Mentioned that her husband and brother in law got the shot and were feeling fine. No further details provided. The action taken in response to the events for ibuprofen was dose not changed , for hydrochlorothiazide was dose not changed, and for valsartan was dose not changed. The outcome of the event rash of heat from her neck up to her head was recovering; event got nervous feeling was unknown, while the other events was not recovered.
71 2021-02-23 flushing Very severe chills, flushing, hives, nausea
71 2021-02-23 tenderness When the patient returned for her second dose she reported that she had pain and a marked decrease... Read more
When the patient returned for her second dose she reported that she had pain and a marked decrease in mobility in that arm and shoulder for about 2 weeks. She stated it is much better but still sore to the touch. She left the original band-aid in place from that vaccination and indeed, a worn band-aid was in place. The injection site was very high in the left shoulder, near the boney prominence.
71 2021-02-24 hot flush - erythema diffuse body, hot flashes, headache and ecchymotic areas
71 2021-02-24 pain in extremity 1st dose - sore arm, foggy first couple days, moderate vertigo day 3. 2nd dose - sore arm, mild head... Read more
1st dose - sore arm, foggy first couple days, moderate vertigo day 3. 2nd dose - sore arm, mild headache first couple days, severe vertigo day 5.
71 2021-02-24 flushing, tingling Within 15-minutes of vaccination, the patient reported feeling flushed with tingling in their finger... Read more
Within 15-minutes of vaccination, the patient reported feeling flushed with tingling in their fingertips. Denied CP, SOB, or difficulty swallowing. EMS evaluated patient on-site. Patient was hypertensive (172/92) with all other vitals WNL. Physical exam was unremarkable. Patient refused transport to ED for further evaluation.
71 2021-02-24 feeling hot Woke up extremely hot, nauseaus. At 0410 I felt like I had to have a bowel movement, sat on toilet f... Read more
Woke up extremely hot, nauseaus. At 0410 I felt like I had to have a bowel movement, sat on toilet for awhile, projectile diarrhea began. Then vomiting. Same symptoms I had with Covid in June. extremely tired for about a week. Called my son who works for Pfizer the next day (the 4th of February). I want to reschedule my second vaccine for later in March because my Endocrinologist has put in a referral to have my antibodies tested. Unfortunately I just had a tooth extracted and am on antibiotics, not sure if that will affect the antibody test or the second vaccine.
71 2021-02-25 feeling cold, feeling of body temperature change, pain in extremity, feeling hot My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel we... Read more
My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel well; Nauseous; I got cold; Sick; was very hot and so hot; was round up/she was feeling she would faint; waves of feeling like i would pass out; it was just being very hot, then being cold; Blood drained from my head, I just knew I was going to pass out; I took 0.2 rather than the 0.3ml of the first dose; very fast heart rate intermediately for many day; squeezing of chest; muscle hurting/Pain in my body in every muscles, my fingers, my hands, my calves, my feet, my back, neck, everything; digestive disorders; feeling gassy, uneasy; stomach abdomen was just tight; abdominal issue; feeling gassy, uneasy; stomach abdomen was just tight; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: E18982), on 21Jan2021 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient reported that based on her history of reactions to medications, the nurses giving injections "decided 0.2ml instead of 0.3ml", which is what they gave, so she got 0.2 that is two-third of the shot. The 2nd shot was for 8'oclock on 11Feb2021. She is very sensitive to shots, vaccines, and to all medications and injections and things like that. She has sensitives thanks to two concussions she had in her life. She never was before that she had two concussions. Second one had a crazy man hit her after that just noticed that just have reactions not adverse or dying but definitely take rest of everything. So she take less of a shot, like a dental shot or cortisone shot, which she had taken in the past. If she has dental shot she cannot take Novocain, had to take Carbocaine or Marcaine and they give her half. Also she had been taking cortisone shot for shoulder for rotator cuff injury. They also have to give her less. Or flu shot: she takes half one week and come back for the other half the next week. Just have reactions. She told to when arrive for medication and did have one anaphylactic reaction but that was to cat skin dye, was told to this two nurses who was administering the vaccine and said to them she was really afraid to take. It is just too much for her. She knows her body. She is sure have reaction but is really afraid and don't know what is the first one will do to her. They just did two nurses and she decided that she will be taking 0.2 instead of 0.3ml which is what they gave. She got 0.2 so that two third of the shot and waited the half an hour, a nurse watched her card and 7 other cards. She did not have the anaphylactic reaction. She went home. Her arm hurt and started to get little tired. The events started the day that she got the shot. Like about 3 or 4 hours later. It is just few hours later she couldn't watch TV so went to laid down and an hour later she woke-up. She walked to her kitchen and blood drained from her head, she just knew she was going to pass out. Her stomach suddenly did not feel well. She tried to get back her bed but she was round up and as far as the bathroom. She got very nauseous, she laid down on bathroom floor. She thought she was sick but didn't round up having to use toilet of few times. Although while she was feeling she would faint. She was very hot and so hot. While lie down, she couldn't even pulling off her pajamas. So when she got cold so she was pulling a towel down and stop and she laid to for two hours, she finally got to her bed. It was a terrible experience. Next day she drank water and had potatoes prepared and went up eating back to later baked potatoes. Next day luckily she did not have repeat of the nausea. She didn't have that anymore of. She did have abdominal issue just not diarrhea or anything but just not feeling well, feeling gassy, so uneasy. This all lasted, that part lasted for 7 days. What concerned her was especially beside first day it was few days she got off again. She was just feel blood drain but not this first time she laid on floor. She couldn't sit on chair to watch TV for about 3 days. She mostly laid on bed but she would get very hot and then very cold during the day. She would get very fast heart beat not continue but really fast like heart was pounding her chest. She felt like someone has their hand inside her body squeezing her chest. She got afraid but didn't want to go hospital. She didn't think she was sick enough. She was concerned. So that was happened and this last was for about 7 days. Then the squeezing of chest part went away. She doesn't want to wind-up on the floor feeling that sick again, she felt so sick it felt like food poisoning. After that, it was just being very hot, then being cold, the fast heart rate, every muscle hurting. Those were the main things that continued for a week. And digestive disorders. It all lasted for about 13 days. She was concerned she had a very fast heart rate intermediately for many days, for about a week. And that's considered an adverse reaction and also she was getting waves of feeling like she would pass out, everything would drain from her head. She experienced stomach ache, feeling hot then cold. She wants to do precautions before taking the second dose on 11Feb2021. She did take may be 3 days later two Tylenol but didn't take anything (clarification requested). She didn't even take vitamins during that time. She was afraid to take anything so she did not. At the same time also there was pain in her body in every muscles, fingers, hands, calves, feet, back, neck, everything. Her stomach abdomen was just tight. She was concerned that last for few days. In last few days she started feel herself and now she is going again tomorrow. So that how she reacted. She doesn't know how much of this shot she told them she could tolerate because everybody is saying second shot will give you more reactions. All she can take this more than that because that was lot. She wants to be herself, don't want laying on floor, don't want to have 105 temperature or anything. The patient was asking if she should take another 0.2ml another two-third of the shot. She just asked them for half that is 0.15 would that be a big difference. She needed to know by 8 o'clock tomorrow. I might be in a queue to get it. She stated: 'So, that's my concern. I'm all alone, I'm a senior, I have no family. I lost my mother to covid. I know I need this vaccine, but I just, I cant get that sick and I'm so afraid I'll wind up with a 105 something, fainting away and no one knowing'. She was asking if reactions after the 2nd dose are worse than the 1st dose, if she didn't have anaphylaxis after 1st one, she shouldn't have it a 2nd time, right. She said, "1st half of flu shot, I get sick, then the 2nd half nothing". She also asked if she can take medications after the vaccine, like Tylenol, or irritable bowel syndrome (IBS) medication she takes as needed. The events resolved, but the patient reported it took her like 13 days before she felt better.
71 2021-02-25 cold extremities On the evening of 2/23/221 at 9:00 pm, resident reported feeling SOB, BP 80/44, Pulse 53, O2Sat 95% ... Read more
On the evening of 2/23/221 at 9:00 pm, resident reported feeling SOB, BP 80/44, Pulse 53, O2Sat 95% on 3L oxygen, hands cold, pulse weak. Temp 92.5F MD notified. EMS activated. EMS arrival and HR 20. Family refused transport to ER. Resident expired at 2:40 am on 2/24/21 Meds continued: duloextine, VITd2,hydralazine, synthroid, lisinopril, mag ox, folplex, pantoprazole, potassium chloride, ellipta, ensure, hydrocortisone cream, boost, deprox, xanax, morphine, lorazepam, tylenol, albuterol inhlation, ventolin inh.
71 2021-02-26 pain in extremity I had a sore arm a few hours after the injection as well as swelling and redness at the site. It con... Read more
I had a sore arm a few hours after the injection as well as swelling and redness at the site. It continued for a day or two. No problem until my arm started itching Thursday and I noticed the redness and itching as well as a little swelling.
71 2021-02-26 pain in extremity Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the n... Read more
Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the next day; general malaise feeling; loss of appetite; headache; slight swelling of sinuses and rash on face. Took Benadryl the first and second nights, used hydrocortisone cream on rash, took Tylenol. End of day three feeling better, almost normal.
71 2021-02-26 flushing Systemic: Flushed / Sweating-Mild, Additional Details: pt felt flused after 10 minutes. Refused bena... Read more
Systemic: Flushed / Sweating-Mild, Additional Details: pt felt flused after 10 minutes. Refused benadryl due to previous reaction. Took asa 81 mg and zyrtec 10 mg. Symptoms resolved.
71 2021-02-27 tremor 12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted... Read more
12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted 2-3 days, but the following symptoms are still present (10 Days post 2nd dose): HA, lethargy, fogginess and tiredness
71 2021-02-27 pain in extremity Moderate to severe pain in right wrist, fingers & arm
71 2021-02-28 weakness Patient presented to Hospital via EMS secondary to a fall outside where she fell of her hands and kn... Read more
Patient presented to Hospital via EMS secondary to a fall outside where she fell of her hands and knees complaining of weakness and unable to get self up.
71 2021-02-28 tremor Patient received her second dose of the Pfizer vaccine today at 1330, she waited the required 15 min... Read more
Patient received her second dose of the Pfizer vaccine today at 1330, she waited the required 15 minute observation time, was feeling fine and left. She returned to the vaccine clinic around 1415 reporting that she was having trouble breathing. Security called the charge nurses and alerted them that a patient needed assistance. Writer came out to patient who was seated in her car. We assessed patient who was visibly having difficulty breathing and was unable to respond to questions without difficulty breathing. Emergency medication box was opened and epinephrine was prepped. We assessed patients allergies and recent medications taken. Patient denied hx of breathing problems or anxiety. Pt denied chest pain. Per protocol for potential allergic reaction, 0.3ml of epi was given at approximately 1426 via IM injection in the pt's left arm. ED triage nurse was called and asked to come assist. Two ED technicians with stretcher arrived and with writer accompanying them transported pt to ED.
71 2021-02-28 feeling hot Severe abdominal pain. Started as diffuse cramps, surged to the most severe pain I have ever experie... Read more
Severe abdominal pain. Started as diffuse cramps, surged to the most severe pain I have ever experienced. The pain extended below my left rib through the area above my hip to my navel and then to my entire abdominal area. As noted, it ranged from severe cramps (maybe only a 4 on a NPRS) to searing pain that I would mark as a 10 on a NPRS. This subsided and then surged about 5 times in the space of 30 minutes. At one point, I got very hot, but I didn't have a fever. The pain was so bad and I felt so horribly sick that I was about to ask my husband to take me to the ER. I had a Cesarean section in 1978 followed by two natural, unmedicated VBAC births in 1981 and 1985, and, although I know we "can't remember pain," the pain I experienced last night was far, far worse than the pain of childbirth. After it went away, everything immediately went back to normal, as if it hadn't happened.
71 2021-02-28 burning sensation She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a ... Read more
She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: E13247) via an unspecified route of administration on 19Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included A-fib. Concomitant medication included apixaban (ELIQUIS). Had COVID-19 Vaccine on 19Jan2021 and everything was fine. Had a headache and a little bit of malaise on 20Jan2021. After two days was ok. On 21Jan2021, broke out in what she thinks was shingles. Not 100% sure if it was a major rash or shingles. Wanted to know if that was a possible side effect. Patient was taking Valaciclovir (VALTREX) for Shingles. Doctor suspected it was shingles, but it was possible she had shingles brewing before the COVID-19 Vaccine or the COVID-19 Vaccine brought the shingles out. Second COVID-19 Vaccine is scheduled for 09Feb2021, patient was scared and afraid of it. Doesn't know what to do. On 20Jan2021 she was very tired and had a headache. Next day was ok. On 21Jan2021 thought she had bug bites. Started itching. Then it began traveling and she realized it was not bug bites. She started experiencing burning. Went to two Urgent Care and her Internist. Was told it was basically shingles. Her internist was on the fence because she just had the COVID-19 Vaccine and wasn't certain. Caller stated it was ironic that she broke out after the vaccine. Caller's internist stated for any rash it would be treated the same with Valtrex. Internist stated chances were the rash was viral so if it's not shingles, would be treated with Valtrex. Rash and Itching: Wasn't very bad on Saturday, 23Jan2021, which was the first time she had someone look at it. On Sunday, 24Jan2021 it was full blown and really blossomed. Was initially treating rash as if it was bug bites. Was applying Benadryl tropical. On Sunday, 24Jan2021, started taking Valtrex. Outcome of the events headache, malaise, fatigue was recovered on n unspecified date, while unknown for the other events.
71 2021-02-28 weakness, numbness Weakness, dizziness, numbness in face, hypertension-evaluated by EMS and refused transportation.
71 2021-02-28 numbness severe glaucoma; Intermittent itching, numbness around my left eye & down cheek; Intermittent itchin... Read more
severe glaucoma; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; Visual field defect; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; This is a spontaneous report from a contactable consumer. A non-pregnant 71-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EM9810), via an unspecified route of administration in the right arm on 05Feb2021 at 15:30 at 71-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the bnt162b2 administration. Medical history included controlled blood pressure high (HBP) from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing; "known allergies: comparing." Concomitant medications included unspecified medications taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccination. On 08Feb2021 at 07:30, the patient experienced: severe glaucoma (medically significant), intermittent itching, numbness around my left eye & down cheek (non-serious), visual field defect (non-serious); with no treatment received. The clinical outcome of the events was not recovered. The patient was not tested for COVID prior to the vaccination and post vaccination.
71 2021-02-28 weakness strength difficulty, tiredness, leg weakness,
71 2021-03-02 pain in extremity Chills, body aches, headaches, slight nausea, sore arm
71 2021-03-02 weakness Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a co... Read more
Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.
71 2021-03-02 pain in extremity could not get her legs to work; her arm was sore; Dizzy/ Dizziness was reported as worsened; This is... Read more
could not get her legs to work; her arm was sore; Dizzy/ Dizziness was reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) intramuscular on the right arm on 27Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included peritoneal dialysis from Apr2020 and diabetes (diagnosed about 30 years ago) both ongoing; blood thinner, 2 stents a and a balloon from Dec2020 and high blood sugar. There was no family medical history. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) for stents, insulin detemir (LEVEMIR) for diabetes, insulin aspart (NOVOLOG) for high blood sugar during the day and clopidogrel bisulfate (PLAVIX) as blood thinner all were ongoing. The patient stated that her arm was sore on 27Jan2021 and that was no big deal. She said that she got so dizzy and was walking like a drunk. Dizziness was reported as worsened. Patient said that last night (31Jan2021) she tried to get to the bathroom, but she could not get her legs to work. She said that her husband had to lead her to the bathroom with a walker and when she was done, she could not get back to bed. She was scared to death last night when her legs would not work. She said that she thought her symptoms would just go away. What should she do about her symptoms? The facility where the vaccine was administered was in a clinic. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office or Emergency Room. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. Outcome of the events was not recovered.
71 2021-03-03 tingling, numbness Left arm about 2 hours after shot got very heavy. Hand and fingers numb and tingled for about 15 min... Read more
Left arm about 2 hours after shot got very heavy. Hand and fingers numb and tingled for about 15 minutes then was ok After 1 hour I had I think like brain fog and hard time to navigate my phone. Seem just like confused or light headed kind of during day. Misplaced phones or things next day Next day at night just felt around 11pm getting ready for bed my head was ok and I could think ok again
71 2021-03-04 bell's palsy Bell?s palsy. Left eye will not close and left mouth droopy with muscle weakness left side.
71 2021-03-04 pain in extremity Fever, headaches, chills, sore arm. Loss of taste that started on day 3 and lasted 24 hours.
71 2021-03-04 weakness Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started aroun... Read more
Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started around 7am on March 3rd, when she woke up. The symptoms lasted almost all day, and he started to feel better around 6:30pm on the same day, March 3rd. He was able to eat and drink at this time without feeling nauseous. On March 4th, he experienced mild headache and was feeling a little dizzy, but much better. She is able to eat and drink, and move around the house now.
71 2021-03-04 tingling Pt. in observation was feeling tingling of arm, paramedics assessed blood pressure was high 174/80. ... Read more
Pt. in observation was feeling tingling of arm, paramedics assessed blood pressure was high 174/80. Once symptoms subsided paramedics release pt. to leave.
71 2021-03-08 pain in extremity Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my ... Read more
Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my torso; feeling of muscle heaviness that I almost felt paralyzed; extreme body ache; chills; I had a bad headache; stinging on both sides of my head and on hands and feet; was very lethargic; arm became real sore and was painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiry date not reported), via an unspecified route of administration on the left arm on 27Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included mild lupus, post concussion syndrome (PPCs) and allergies: sulfur (very sensitive to large doses) from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole magnesium (NEXIUM), tramadol, alprazolam and acetylsalicylic acid (ALKA SELTZER). The patient reported that after just a few hours on 27Jan2021, their arm became real sore and was painful to use until next morning, was sore for 2 days. Hurt after much normal use. Woke up on the morning of 28Jan2021 (3 am) with chills, extreme body ache and feeling of muscle heaviness that they almost felt paralyzed. They could still move. They had a bad headache and stinging on both sides of their head and on hands and feet. They took aspirin and went back to sleep. When they got up they felt some better, but did not feel well and was very lethargic. That night they took another aspirin before bed. On the morning of 29Jan2021 (second day ) they again woke up at 3 AM to extreme body ache, the same heavy paralyzing feeling, but this time their lower back felt really heavy and there was a pounding sensation up and down their torso. They repeated the aspirin dose and went back to bed but did not sleep anymore that day. They did feel some better but still very lethargic. Next day better, but took 5 days to feel some normal w/o fatigue. The patient is very sensitive now to regular meds. Therapeutic measures were taken which included aspirin. The patient was recovering from feeling of muscle heaviness that I almost felt paralyzed, extreme body ache, chills, headache, stinging on both sides of my head and on hands and feet, lethargy recovered from arm became real sore and was painful on an unspecified date, while the outcome of the other events was unknown. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since vaccination.
71 2021-03-09 discomfort, pain in extremity, muscle spasms, tingling, weakness After COVID vaccine #2- headache started same evening around 5 pm, tiredness, painful charlie horses... Read more
After COVID vaccine #2- headache started same evening around 5 pm, tiredness, painful charlie horses. 2nd night- chills, tiredness, sore legs, difficulty walking. 3/7/21- woke up with painful legs, heaviness, unable to walk, continued mild headache. treatment include: Tylenol, Gabapentin and lidocaine cream, avoiding narcotics rehab therapies
71 2021-03-10 facial pain, pain in extremity, numbness beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; fa... Read more
beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; face lips; felt paralyzed/Felt like I couldn't move it like paralyzed a little bit; whole left side of body started going numb/Left side was numb around 7 or 8 that night/all left side was numb; pains in all of her face; pain and soreness in arm/arm was painful; tachycard, high heart rate; very tired, sleepy; very tired, sleepy; headache, heavy in her head; pain in both ears; This is a spontaneous report from a contactable consumer (patient). This 71-years-Old female patient received the first dose of (Pfizer Biontech Covid 19 Vaccine, Lot No. EN6198) intramuscularly at single dose on 23Feb2021 for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. Past dug included flu vaccine in Sep2020. The patient received her first dose of Covid 19 vaccine on 23Feb2021 at 3:30 in the afternoon. She came home and felt, not bad at any time but more or less towards 6:00 or 7:00 at night she started feeling bad. Her whole left side of body started going numb around 7 or 8 that night. Her arm was painful, face lips and all left side was numb. Felt like she couldn't move it like paralyzed a little bit. Clarified as whole left side, even her leg, her feet everything on that left side. She started feeling pains in bones of head, especially her face, clarified all of her face and her left side was numb even her lips on the left side were numb. Her tongue was a little numb. She had muscle and joint pain. The pain, of course, in the arm, but that was normal. Clarified pain in the arm as the injection site. She didn't feel any swell there. She did not take medication for anything. She used a lotion. The lotion was trividol aloe vera arnica caleudula and helped to relive the pain. The arm was still a little painful but it's not bad but that feeling made her tachycard, clarified as high heart rate, feeling like boom boom boom, but she did not have any shortness of breath. The high heart rate was gone the same day. She had no fever or chills. She felt very tired and slept for about 10 hours but during the sleepy she started feeling a headache she couldn't get up because she was so tired and she felt pain in both ears. She had not been to the doctor in a while. She was still old fashioned so she carries everything in a little telephone book. While trying to read information caller states she had to change her eyes. She still felt numbness in left side of left leg but she thought it might be because she had not been exercising. When she was waking up around 9am in the morning, it was yesterday that she felt better in regards to the paralyzed feeling. When pains in her face came she felt and she thought what is this? It only lasted for a little while. It was during the night. The pain and soreness in arm at injection site is still there, she did not feel any swelling, or hot at that site. She confirmed she still felt a little tired, sleepy. It's getting better. She may feel a little heavy in her head and would like to go to sleep, but she was not sleeping. She had many things to do and knew she had to be up. The headache went away and was gone on 24Feb2021. It was persisting for a while, not too hard or heavy, but it resolved by 2 or 3 in the afternoon on the 24th. In regarding to pain in ears she mentioned she no longer had. She had beeps, noise in her ears even at the time she went to bed it was better. The outcome of events paralyzed, pain in arm, tired, sleepy, was recovering, the outcome of events tachycard, pains in all of her face, pain in both ears was resovled, the outcome of other events was unknown.
71 2021-03-14 numbness, pain in extremity I cannot move my pinky on my hand and my whole hand you know it feels like it is a nerve or somethin... Read more
I cannot move my pinky on my hand and my whole hand you know it feels like it is a nerve or something; I cannot think straight; the whole hand hurts; Hand of the arm where injection was placed is numb; a lot of pain; I could not move my thumb on my hand, very painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EN5318), via an unspecified route of administration on 04Feb2021 01:15 at a single dose in left arm for COVID-19 immunization. Medical history included hypertension/high blood pressure, diabetes. No other vaccine in four weeks. The patient was not a pregnant. Concomitant medication included atenolol, valsartan (DIOVAN) for high blood pressure, glimepiride for diabetes, gliclazide (GLIZA) for diabetes, insulin for diabetes. The patient had the first Covid shot (Clarified as Covid19 vaccine Pfizer) on Thursday (04Feb2021) and the next day (05Feb2021), the patient could not move her thumb on her hand, very painful. The patient experienced hand of the arm where injection was placed is numb and in a lot of pain on 05Feb2021. Now (06Feb2021), she cannot move her pinky on her hand and her whole hand you know it feels like it is a nerve or something. She did not know what it feels like and it is on the same hand as she got the shot. She cannot think straight. She believed it was later that night, going into the morning. Well, it might have been in the morning more. Probably in the morning and then the rest of the hand hurt me and now her pinky, the whole hand hurts. She cannot move it and it hurts that much. The patient underwent lab tests and procedures which included height: about 5'1, weight: about 200 lbs on an unspecified date. Adverse event resulted in none of the above. No treatment received. No known allergies. The outcome of events was unknown
71 2021-03-15 burning sensation, weakness Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to conce... Read more
Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to concentrate , extreme weakness & fatigue, extreme focused joint pain, headache, coughing and difficulty breathing requiring multiple nebulizer uses every 2 hours over 2 weeks, headache. Face & body rash, . Persistent exhaustion continues requiring 2-3 hour daily naps & non Fibro brain fog continues at 3 weeks.
71 2021-03-18 bell's palsy Bell's palsy left side of face; This is a spontaneous report from a contactable consumer (patient). ... Read more
Bell's palsy left side of face; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) at the age of 71-years-old, intramuscular on left arm on 28Feb2021 at 13:30 at single dose for COVID-19 immunization. Medical history included asthma, allergies, blood cholesterol abnormal (reported as cholesterol), and allergies to penicillin which were all ongoing. The patient was not pregnant. She has no COVID prior to vaccination and has no prior vaccination and other vaccines in four weeks. Ongoing concomitant medications included zileuton (ZYFLO CR) and budesonide, formoterol fumarate (SYMBICORT) for asthma; levocetirizine and azelastine hydrochloride, fluticasone propionate (DYMISTA) for allergies; immunoglobulin human normal (HIZENTRA); and atorvastatin (LIPITOR) for cholesterol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264) at the age of 71-years-old, intramuscular on left arm on 02Feb2021 at 14:30 at single dose for COVID-19 immunization. The patient previously took aspirin and experienced allergy. The allergy was reported to be ongoing. The facility type where the vaccine was administered as reported to be other and mega-site. The patient experienced Bell's palsy left side of face on 01Mar2021 which required physician office visit. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event and included treatment with valacyclovir 1g, 3x/day. The outcome of the event was not recovered. The event was assessed as non-serious by the reporter.
71 2021-03-18 pain in extremity, weakness Four days after the first dose of Pfizer on 2/24/2021, got blisters in mouth bleeding, bruises on th... Read more
Four days after the first dose of Pfizer on 2/24/2021, got blisters in mouth bleeding, bruises on the legs, arms, hands, and shoulder, sore legs, very weak, difficult to sleep.
71 2021-03-21 one side paralysis Patient presented with frequent falls and left sided weakness with severe headaches for greater then... Read more
Patient presented with frequent falls and left sided weakness with severe headaches for greater then 24 hours.
71 2021-03-23 weakness 15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat ... Read more
15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat tightness, sensation of difficulty swallowing. Then abdominal pain, nausea, then feeling of something really wrong, I didn?t feel well, then got weaker and weaker, couldn?t lift arms, and felt extremely fatigued, trouble staying awake. Taken by ambulance to medical center. On route, ambulance stopped and another team came in. I was given epinephrine, zofran, Benadryl, and maybe a steroid? Not sure. When I arrived at hospital, t think I was given dexamethasone and famotidine. I was barely awake but could speak. Could not hold anything. After several hours, they woke me up, I felt myself again, and I was discharged. Following days I felt exhausted and dizzy, and had a headache. Took prednisone for five days.
71 2021-03-24 weakness Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk o... Read more
Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk or get out of a chair); Severe weakness (could not walk or get out of a chair); Nausea; Diarrhea; Mild headache; Blurred vision; Significant swelling at injection site which spread to full upper arm; Significant swelling at injection site which spread to full upper arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 08:00 (lot number: EN6199) as single dose for COVID-19 immunisation. Medical history included osteoporosis (not bothersome), known allergies to some antibiotics, and felt dehydrated. The patient was not pregnant at the time of vaccination. The patient was taking other medications like grapefruit juice. The patient previously received first dose of bnt162b2 on 12Feb2021 (dose number 1, lot number: EL9267, administration time: 08:00 AM, vaccine location: left arm). No other vaccines received four weeks prior to COVID vaccination. On 05Mar2021 12:30, the patient experienced severe weakness (could not walk or get out of a chair), delirium (was convinced that (name) had taken over her body and was the cause of her illness), nausea, diarrhea, mild headache, blurred vision, significant swelling at injection site which spread to full upper arm over next three days and remains troublesome. Other symptoms (unspecified) lessened within two to three days and are no longer of concern. The AEs resulted in doctor or other healthcare professional office/clinic visit. Event 'significant swelling at injection site which spread to full upper arm' were treated with application of steroid cream (for arm only). Outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination.
71 2021-03-25 hot flush heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day... Read more
heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day after the vaccination; 6th day after the shot she had hot flashes and swelling; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Feb2021 as SINGLE DOSE for COVID-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. Medical history included allergies to penicillin and some other things. There were no concomitant medications. The patient experienced heart fluttering and dizziness 2nd day after the vaccination; repeated 3rd day after the shot; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness. All events started in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was given for the events. The outcome of all events was unknown. Information on the lot/ batch number has been requested.
71 2021-03-27 burning sensation, difficulty speaking On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eat... Read more
On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eaten that morning: mashed potatoes, milk, cream of wheat - Throughout the day, patient notes she was not feeling well. At 6 PM, she developed rashes on her hip, groin, and abdomen. At 7 PM, she took diphenhydramine 25 mg. By then, her mouth was swollen. Her tongue also started to swell. At 9:30 PM, she had increase itching, burning sensation, and hives worsened. Developed a large rash on her butt. At 10 pm, took a second diphenhydramine; notes she had tongue swelling voice changes (gravel-like quality), and bilateral facial swelling. She was also breathing rapidly. Went into the ER, was checked in after ~3 minutes. She was administered epinephrine IM, IV diphenhydramine, solumedrol 125 mg, and IV famotidine. Patient was also intubated for respiratory distress and airway swelling, and admitted to the ICU. Was intubated until the afternoon of the following day.
71 2021-03-28 weakness, tingling Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swel... Read more
Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
71 2021-03-31 seizure Her husband called to report that he could not arouse her on 3-28-21. Advised to call 911.
71 2021-04-02 pain in extremity Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and tur... Read more
Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
71 2021-04-03 weakness, one side paralysis Six days after receiving the vaccine I woke up on Friday, March 12, with a complete feeling of exhau... Read more
Six days after receiving the vaccine I woke up on Friday, March 12, with a complete feeling of exhaustion. Weakness was extreme in my whole left side and could barely put weight on the left side. I thought this would pass so tried to get along. The next day, Saturday, March 13, the complete exhaustion was even worse. Trying to get out of bed was very hard. I called a friend and went to hospital here . I was admitted, tested, and kept for several days. The report came back that I had a series of "mini" strokes on the right side of my brain, affecting the left side of my body. I could no longer walk at all without aide of person or a walker, After that I was taken to rebab, . I was given pt, OT, etc, and discharged several days later. No doctor or staff could tell me whether this was caused by the vaccine but the close days of administering the vaccine and the sudden onset of symptoms make me very concerned. How can I take a 2nd vaccine without knowing if that will have a worse effect or kill me? Can I take a different vaccine for the 2nd round, without a risk of something worse happening? Can you report to me if there is any correlation at all between this vaccine and my mini strokes?
71 2021-04-09 slurring Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan... Read more
Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan. All came back normal. March 26, MRI done. That showed a stroke. Then on March 31st, saw Drs. (neurologist). Confirmed the stroke and suggested Speech Therapy. Starting on April 19, Sppech Therapy begins. Since Stroke, I have to sleep 12-15 hours a day.
71 2021-04-11 pain in extremity About 30 minutes after 2nd vaccine, I felt abrupt pain, shocks and tightening in 3 fingers on my rig... Read more
About 30 minutes after 2nd vaccine, I felt abrupt pain, shocks and tightening in 3 fingers on my right hand, starting at the knuckles down to finger tips. Pain occurred with or without movement. Knuckles are swollen on that On day 4, pain moved from knuckle to the joint between knuckle and finger tip. Pain occurs mostly with movement but not always, and is from mild to moderate pain. It is day 16 post vaccine, and I still have intermittent pain in the 3 fingers where I hadn?t previously had any prior to vaccine. 30 hrs after 2nd vaccine, I also had a severe headache lasting about 1 1/2 hrs.
71 2021-04-21 numbness, pain in extremity Patient reports she started to have RT arm and shoulder pain after the injection, which was expected... Read more
Patient reports she started to have RT arm and shoulder pain after the injection, which was expected side effect, so patient did not report to the clinic. However, the pain did not go away over 3 weeks and it started to spread to RT upper back and shoulder and patient also started to feel numb in the area. Patient came to the clinic on 04/22/2021, reporting this is about 1 month and problem persists. Patient is referred out to nuerologist visit, and is prescribed for gabapentin 100mg BID. Will follow up in 2 weeks again.
71 2021-04-24 weakness She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said th... Read more
She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said this what she has, almost like a fibromyalgia; Shingles became aggravated; she had had broken toe on the other foot that was killing her; total fatigue, no energy at all; total fatigue, no energy at all; abscess on tooth that will be pulled tomorrow; She doesn't have the strength that she had before; This is a spontaneous report received from a contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiration date: UNKNOWN), dose 2 via an unspecified route of administration on 11Mar2021 12:00 as SINGLE DOSE, dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EN620) as SINGLE DOSE for covid-19 immunisation. The patients medical history included ongoing asthma since she was 4 years old, ongoing herpes zoster (Shingles) since Nov2019, Raynaud's phenomenon for 20 years, High anxiety, gastroesophageal reflux disease from 4 years. Concomitant medications included amoxicillin at an unspecified dose taken for an unspecified indication for 7.5 days from 29Mar2021 to 05Apr2021; Advair Disc at an unspecified dose taken for an unspecified indication for maybe 30 years she is prescribed twice a day but takes it only once day, fluticasone propionate, salmeterol xinafoate (PROAIR BRONQUIAL) taken for an unspecified indication from an unspecified start date and ongoing; she had been on this for maybe 30 years, as needed, montelukast sodium (SINGULAIR) taken for asthma from an unspecified start date and ongoing for 30 years, multivitamin, sambucus nigra, sodium, zinc (MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC) taken for an unspecified indication from an unspecified start date and ongoing, she says she has been taking this forever because she never ate vegetables, magnesium sulfate (MAGNESIUM SULFATE) taken for bowels from an unspecified start date and ongoing from around 4-5 years as it helps with her bowels, felodipine (FELODIPINE ACTAVIS) taken for an unspecified indication from an unspecified start date and ongoing, for 30-40 years; rosuvastatin calcium (ROSUVASTATIN CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing; calcium, colecalciferol (CALCIUM PLUS D3) taken for bones from an unspecified start date and ongoing for 30 years once menopause started, for bones, famotidine (FAMOTIDINE) taken for an unspecified indication from an unspecified start date and ongoing, says she has been on this for maybe 4 years because she was eating a lot of Rolaids. The patient was also taking for concomitant Products Hair, nail, skin vitamin for hair, nail, and skin health and says her nails are nice and strong, she still has wrinkles, but she says that was part of being old. The patient also said flu shot in Sep2020, pneumonia shot, shingles shot on an unspecified date and had nothing. patient says the first shot was nothing, everything was fine, the second shot she was thinking this is good, everything is good, it was on 11MAR2021 but by 14Mar2021 she was in total fatigue, started to get an abscess on tooth, she doesn't think this was because of shot, she has a prostheses, fake hip, her hip was killing her where the actual bone joint was, she had had broken toe on the other foot, that was killing her, she had no energy at all. She says normally, she is 71 years old, she was very active. She says her doctor takes care of everything, in her case she is asthmatic, everything, he does all of her bloodwork. she has to get this tooth pulled, she had some cadaver teeth put in, she went to the gym, everything was great, all the sudden she has an abscess, she went to her periodontist who says it is bad, it needs to be pulled. She says she was going to get her tooth pulled tomorrow. She reports her shingles seemed to get aggravated, her doctor said she will always have this, when she gets upset, aggravated or anxious it flares up, she is now back on the gabapentin, it is like pins and needles under rib cage where the actual shingles were. She says she was asthmatic but it did not bother her lungs one bit, she did not have any lung issues. She says everything happened on 14MAR2021. She reports that she does find she gets tired, she cooked all day Saturday, she stood over the stove all day, she did nothing but that all day. She says her tooth was bright red, her whole cheek and still, she took the last antibiotics, a heavy dose, last dose this morning too. She reports her foot is not bothering her anymore, her hip is still a little sore. She says she can do 2 miles in the gym, it was hard to exercise with mask on, it is always cold, she can't walk, she's limited to what she can do right now. she said this what she has, almost like a fibromyalgia, she diagnosed herself as having this condition, she Googles it and it says its muscle pain, she doesn't have the strength that she had before, she doesn't have hand strength, stamina, to walk a mile killed her, now she can do 2 miles, she is not 100% of what she was, she's coming along though. prior Vaccinations (within 4 weeks); she got her flu shot in SEP2020; AE(s) following prior vaccinations: She says flu shot, pneumonia shot, shingles shot, and had nothing. The patient was recovering from fatigue and asthenia, not recovered from tooth abscess and shingles and rets of the events was unknown. No follow-up attempts are needed. No further information is expected.
71 2021-04-24 muscle spasms severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touc... Read more
severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touch; severe pain in her head, it hurt to touch and had shocks and her whole body would cramp up; her whole body would cramp up; Tourette's; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198, expiration date: 30Jun2021) at the age of 71-years-old, via an unspecified route of administration in right shoulder on 05Mar2021 at 10:30 at single dose for COVID-19 immunization. Medical history included neuropathy in feet caused Tamoxifen (chemotherapy), anal cancer stage IV, breast cancer, double mastectomy, chemotherapy, and lymph node in left arm. Concomitant medications included gabapentin, meloxicam, and vitamins. There were no additional vaccines administered on the same date with the COVID-19 vaccine as well as within 4 weeks. The patient previously took tamoxifen as chemotherapy and experienced neuropathy in feet. The patient received her first COVID-19 vaccine on 05Mar2021 and on 13Mar2021, she experienced severe pain across the front of her stomach. On 19Mar2021, she said she has something, and it was a rash. She went to care facility on 20Mar2021 and was told she has shingles. The patient stated that the doctor just looked at her and said she has shingles, no testing was done. They told her it was ok for her to get the second shot, but she was worried about that. She experienced shingles since 13Mar2021, she still has it. She was supposed to have the shingles vaccine 4 years ago, but it was expensive. Her son heard on the radio that the shot may cause shingles, it may or may not be related but she wanted to let Pfizer know. The rash was starting to go away, and the pain was not, but the pain was far better. She ended up going to the doctor on 24Mar2021 with severe pain in her head since Mar2021, and she didn't know why. It hurt to touch and had shocks and her whole body would cramp up. Her daughter told her she looked like she had Tourette's, it was happening every 2-5 minutes. The doctor couldn't do anything and told her what she could take. It was an additional thing and the doctor said it was probably from shingles but she did not have a rash there. It was completely gone now. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiration date: 31Jul2021), via an unspecified route of administration in right shoulder on 26Mar2021 at noon and stated that it was getting better then, and by 27Mar2021 it was gone completely. She was petrified this was going to happen while she was there to get the second vaccine and they would say she couldn't do it. The outcome of the event shingles was recovering and recovered on 27Mar2021 for all other events.
71 2021-04-27 weakness lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated;... Read more
lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated; weak; dizzy; nauseated; fever; headache; This is a spontaneous report from a contactable consumer (patient). This 71- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 11Mar2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was Public Health Clinic facility. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EN6200) dose 1 on 18Feb2021 04:00 PM, for covid-19 immunization, left arm. No known allergies. The medical history included: Blood pressure abnormal. Concomitant medications included: Prozac, Inderal, Atorvastatin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 09:00 am, Day after 2nd injection, she felt weak, dizzy, nauseated, fever, blood pressure elevated and had an extremely severe headache. That evening I lost partial vision in my right eye, which has been determined to be AION. Vision has not returned at one month out. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included: Blood pressure monitoring and return 13Apr2021. The clinical outcome of the events was not recovered. The patient was not tested for COVID-19 after the vaccination. No follow-up attempts are possible. No further information is expected.
71 2021-04-28 discomfort, pain in extremity muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain... Read more
muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain in left arm; pain in the joints; Red circle around injection site; Weak feeling in arms and legs; body feels heavy; dizziness; Very exhausted; Nausea; Diarrhea; Some cramping in stomach; Brain Fog; Body aches; headache; itchiness; Left arm sore at injection site; anxiety; not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Feb2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes diagnosed 15 years ago, obesity, asthma with bronchitis as a child, allergy to other medications, anaphylactic reaction to sulfas twenty years ago (also reported as 50 years ago), muscle hurt/sore arm usually when she got a flu vaccine (unspecified) once a year, allergies to makeup and clothes (diagnosed at least 50 years ago), heart beats fast, low thyroid and borderline high cholesterol. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for 30 years for low thyroid, nebivolol hydrochloride (BYSTOLIC) taken for 25 years, rosuvastatin calcium, (CRESTOR OD) taken for 2 years for borderline high cholesterol and insulin (unspecified). The patient did not receive any other vaccinations on the same day or within 4 weeks of the vaccine. The patient previously took paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as pre-medication since she had allergic reactions to some things and would get this before the flu shot; as well as salbutamol sulfate (PROAIR HFA) for runny nose and coughing. The patient had the first dose of the vaccine on 28Feb2021, and "they" wanted to give her diphenhydramine (BENADRYL) after the vaccine but could not since she was driving. After the vaccination, the patient was not feeling well for 2 days (as of an unspecified date) and thought she was getting better. On 28Feb2021, the patient experienced anxiety. She was more anxious when "that stuff" appeared on the news on day 4 and 5 after the vaccine. She took a small dose of clonazepam 0.5 mg, dividing the pill in 4 pieces as she never took the whole thing. She took it when she got extremely anxious and tried not to take it because it can be habit forming. She may take it 3 times a week or in the middle of the night. It helped a little bit, but she still felt panicky and upset. She woke up feeling anxious. She did not normally take these medications. The patient reported that she experienced headache (constantly several times a week) and left arm sore at injection site, itchiness/ itching all over body (not constant but still happening) from 28Feb2021. On Mar2021 (day 4), the patient experienced dizziness (comes and goes and was not constant like it was), was very exhausted, nausea (tapered off after 2 weeks), diarrhea, some cramping in stomach, brain fog (still struggling and forgets to take her insulin, not as bad as when she first noticed), body aches. At first, the body aches were a pain in the left knee and left elbow and then moved to various joints and muscles. The left knee and elbow pain persisted without ever going away, but also moved to different areas. The calf muscle in left leg pain is also constant. The patient experienced pain in the joints and stinging pain in left leg (below knee down to ankle) from 04Mar2021, runny nose (tapered off) from 07Mar2021, and on an unspecified date muscle pain, back pain, fever, neck pain, pain in left arm. On Mar2021 (two weeks after vaccination), the patient had a red circle around injection site not all the way filled in, but rim around where she got shot. On Mar2021 (3 weeks after vaccination), the patient experienced a weak feeling in arms and legs and other times when she stood up her body felt heavy (persistent but not every day). The patient spoke with her physician who did not believe the patient about the symptoms and recommended she seek psychiatric help. The patient had not received the second dose of the vaccine because her physician did not recommend it. She was upset because her physician told her she could not get the second shot. She was having worsening anxiety because she had not been feeling well for so long, going on 7 weeks. She visited her physician's office 6,7, or 8 times. The patient underwent lab tests and procedures on unspecified dates which included an ultrasound of the leg (did not have a blood clot), an X-Ray of the back (unknown results) and an MRI of the back (did not find anything) to determine the pain. The physician thought it might be a compression fracture, but the MRI did not show anything. The patient was tested for antibodies on 05Apr2021 and had zero antibodies. The clinical outcome of anxiety, felt panicky, neck pain was unknown; dizziness, headache, runny nose, itchiness, pain in the joints, muscle pain, back pain, fever, very exhausted, nausea, diarrhea, some cramping in stomach, brain fog, body aches, stinging pain in left leg / pain in left arm, weak feelings in arms and legs, body feels heavy, left arm sore at injection site, red circle around injection site, not feeling well, was resolving. No follow-up attempts are needed. Information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s): same patient, different vaccine dose/event
72 2021-01-04 pain in extremity arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she coul... Read more
arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she couldn't get warm at first and then she is cold; high blood pressure/blood pressure was high 190/116; big toes hurting; nausea; dizziness; feeling weakness legs/Leg feeling weak; This is a spontaneous report from a contactable other HCP reporting for herself. A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: CJ1686), via an unspecified route of administration in the right arm on 28Dec2020 15:00 at single dose for COVID-19 immunisation. Medical history included breast cancer on the left side, hypertension, hiatal hernia, glaucoma, heart disease, hypertension, lymphadenectomy (lymph nodes being taken out was about 20 years before) and headache from 27Dec2020. She was working Sunday into Monday morning and she went to the Director of Nursing, and said she has a Headache on the left side of the temple, and so she went to eye doctor, and he had a test order ESR and so she has a hemorrhage in the left eye, and show she doesn't know if this could be bringing on some of the side effects she was speaking about, like the nausea and the migraine. She has had No positive test for COVID prior to the vaccine, she must have had about 20 tests and all were negative. She has not had any Antibody tests. She had pneumonia vaccine maybe in the last 5-3 years and flu vaccine in Oct2020 and she experienced achy arm. On 28Dec2020 the patient experienced leg feeling weak (about 15 minutes after injection), nauseous at 21:00, dizziness. On 29Dec2020 the patient experienced arm hurting (in the morning), lymph nodes hurting on the left side, chills, blood pressure was high 190/116, big toes hurting. The patient was calling to ask if these side effects she was experiencing were normal. On 29Dec2020 the patient underwent ESR with unknown results. The patient reported that her arm hurting began on 29Dec2020 in the morning. The breast cancer diagnosis was prior to the vaccine as well as her lymph nodes being taken out was about 20 years ago. Her Lymph nodes hurting on the left side started on 29Dec2020 in the morning. Her Leg feeling weak started right after the injection, about 15 minutes after on 28Dec2020. The chills started on 29Dec2020 in the morning in which she couldn't get warm. Her feeling nauseous started on 28Dec2020 in the evening like 9 PM. The Temperature 98.1 was her current temperature taken right before the call, as well as her blood pressure. Her feeling dizzy started after getting vaccine on 28Dec2020, she was fine to drive home, but then again on 29Dec2020 in the morning she felt it also. Her legs felt funny like rubbery. The big toes hurting started an hour before, on 29Dec2020 it woke her up since it was jabbing. The outcome of the events was unknown.
72 2021-01-05 weakness she just feels very weak now; room spinning; got very dizzy; This is a spontaneous report from a con... Read more
she just feels very weak now; room spinning; got very dizzy; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 29Dec2020 09:00 at a single dose in the left arm as COVID-19 vaccine. Medical history included blood pressure high (diagnosed a while ago at the time of the report), and she has been taking a medication for it for years. There were no concomitant medications. Patient said she had no new medications or other vaccinations administered with this vaccine. On 29Dec2020 22:00, he patient had a reaction where the room was spinning and she got very dizzy. She would like to know is that normal, since she has to go back for a second shot. She was given the vaccine by a nurse at the hospital she works as technician at which is not a military hospital. She said that the hospital is giving the vaccine to its employees. She got the vaccine yesterday morning around or after 09:00AM, and she was ok during the day. She said that the room spinning started before she went to bed at about 10:00PM, and when she got to her room she noticed everything was moving around. She said then she fell asleep, and it was better today, the room was not moving, she just felt very weak now (30Dec2020). Patient said as her treatment for room was spinning and she got very dizzy was that she fell asleep. The events room was spinning and she got very dizzy were recovering. The outcome of the event felt very weak was unknown.
72 2021-01-07 pain in extremity Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; E... Read more
Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; Every place I touched my head where a blood vessel ran is where the pain was; Terrible chills; Ran the temperature about a 100; Really bad headache; Slight soreness in my arm; Cough; Temporal arteritis; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. Medical history included sinus issues, allergy, hormone replacement therapy. Concomitant medication included estradiol as hormone replacement, metronidazole (METROGEL), vitamins and supplements. Patient stated, "I had the COVID injection 19Dec, the first one, afterwards there was a slight soreness in my arm to take couple of days, that was it, until this past Monday (28Dec2020) which was the 9th day afterwards, I started having chills, terrible chills, ran the temperature about a 100 and had a really bad headache. Woke up the next day (29Dec2020), I had noticed the blood vessels across my forehead were very enlarged like a big varicose vein and were very sore to the touch. I realized that my headache, every place I touched my head where a blood vessel ran is where the pain was. I've googled all my symptoms and the word that comes up when I read about is - Temporal arteritis. I didn't know if there was any possibility that was connected with that injection. Along with the chills and the fever, I had also had a cough and a headache." Patient stated, "I have been taking Ibuprofen two 200 mg tablets, once today and once last night" as treatment. The outcome of everts was not recovered.
72 2021-01-07 weakness she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; ti... Read more
she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; tired; feels like she doesn't have enough energy; dry cough; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Dec2020, the patient experienced signs and symptoms of allergic reactions which was progressing. Mentioned that she had fever, fever with temperature ranging from 98.7°F-102.2°F, body ache, tired and feels like she doesn't have enough energy, dry cough. Wants to know how long does the symptoms last. The outcome of the events was unknown. Information about lot/batch number has been requested.
72 2021-01-09 pain in extremity Sore arm
72 2021-01-13 pain in extremity, feeling cold Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to... Read more
Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to her elbow; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; Nausea; total loss of appetite; stated that she gained 10lbs, but she is very physically active.; either not making blood or there was an interference; she was freezing/she woke up cold and could not get warm/ felt cold; she had a little headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021), intramuscular at left arm on 31Dec2020 at single dose for covid-19 prophylaxis. Medical history included low sodium, Covid-19 in Nov2020 (She had felt sick for a week and on 13Nov2020 she went to the ER and they did blood tests and she could not eat or drink for 3 days. She stated that she had 4 different IV fluids going and one of them was sodium and the other was for nausea), blood did not clot properly, broke her back. There were no concomitant medications.The patient had a unique reaction after receiving the Covid-19mRNA Vaccine. She clarified that she never had a reaction to a shot before. She received the vaccine on 31Dec2020 and was fine for the first 20 hours. She said that the next morning on 01Jan2021 at 0600 she woke up cold and could not get warm. She said that she spent the next 24 hours to where she kept adding clothes and blankets to keep warm. She stated that she was freezing and the she felt like the interior of her body was freezing even down to her toes felt cold. She also had injection site pain and the arm felt heavy and stated that the pain extended from her shoulder down to her elbow. She stated that the injection site pain was kind of delayed. She had aches and pains. She said that some of the pain went from the injection shoulder and spread to the middle of her spine. She had nausea and total loss of appetite and could not even eat. Her aches and pains after the vaccine were similar aches like she had with the Covid. She said that she had a terrible headache when she had Covid though. She stated that after the 24 hours of receiving the vaccine she had a little headache, but she took a migraine pill for it. She said that she was able to shed clothes, but she could not take a shower, but within 24-36 hours she was back to normal like it all never happened. She said that was when she figured out it was like her hemorrhaging with one of her childbirths. She explained that she had 3 children and hemorrhaged with each of her child births and was going into shock with one of them and felt this freezing sensation due to blood loss. She thought that her reaction to the vaccine was so bad that she was either not making blood or there was an interference. There was some kind of weird interruption. She said that her blood clots break down from minutes to hours after her child birth or with dental procedures. She had a PAI-1 deficiency or Plasminogen Activator Inhibitor-1 deficiency. She said that there was also something deeper that her doctors had not figured out yet too. She said that her blood did not clot properly. She said that she did not bruise or anything, but she was not allowed to have internal surgery without a transfusion. She said that her doctor's started to figure this all out after she broke her back before. She went to a hematologist and had her counts checked regularly. She said that she was being studied by 127 different clinics. She gained 10lbs, but she was very physically active. This was her first dose of teh vaccine. She said that her doctors told her that she needs to be under 48 hours of observation if she gets the second vaccine. Her primary care physician recommended that she did not take another mRNA vaccine. She said that she was taking their advice and canceled her second dose appointment. She said that when she had Covid-19 they did a Chest x-ray on 13Nov2020 and she had low sodium. She said that they gave her tramadol at the hospital for her headache, but she had already taken 3 migraine pills that day. She had already had her flu shot and read somewhere on a website, that mRNA vaccines might cause unstable anticoagulation. She wondered if it could be possible that Covid-19 antibodies interfered with her injection? The outcome of events was unknown.
72 2021-01-14 numbness, tingling At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has con... Read more
At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has continued with occasional spreading to nose & eyes & sometimes on other side of face - it waxes & wanes Same day - headache, dizzy, exhausted - lasted 2 days Next day - nausea, intestinal discomfort - continuing mildly Mild headache continuing
72 2021-01-15 feeling hot swollen neck near collar bone on left side.hot,
72 2021-01-17 weakness, pain in extremity After waking in the AM of the following morning after vaccination, felt total exhaustion and weakne... Read more
After waking in the AM of the following morning after vaccination, felt total exhaustion and weakness, unable to function with morning duties, left arm sore with a notable lump approximately 2 inches wide. Able to lie down and sleep for about an hour; awoke and felt better. Took two 200mg ibuprofen and laid down again. Within an hour of rest, felt awake with no weakness or exhaustion. Arm was less sore; however placed a warm heating pad on arm throughout the day which improved the lump and soreness.
72 2021-01-19 discomfort Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heavi... Read more
Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heaviness in chest rated at 7/10 pain scale, mandibular pain, appeared diaphoretic and fatigued, skin grey/pale, though remained alert and responsive to questions appropriately. Patient also communicates she was having some chest pain prior to the immunization today, though she indicated on her forms that she was feeling well today. Vital signs assessed, P72 R16 O2 99, patient denied difficulty breathing. Rapid response protocol initiated, applied 2L O2 via NC, transferred patient to wheelchair and taken to ED for evaluation by response team. ED assessment reveals calf tenderness and patient reporting TKA x 2 weeks ago, elevated D-Dimer, CT results pending at this time.
72 2021-01-19 tingling Per RN, patient reported tingling fingers and itchy palm on R arm during 15-minute observation perio... Read more
Per RN, patient reported tingling fingers and itchy palm on R arm during 15-minute observation period post-Pfizer COVID-19 vaccine (Lot # EL1283). Diphenhydramine 25 mg PO administered. No additional symptoms observed. Patient discharged ambulatory in NAD.
72 2021-01-22 flushing Rapid heartbeat, rash, hives, itching, felt flushed, no fever. I still have mild symptoms.
72 2021-01-23 pain in extremity sore arm, slight fever, extreme fatigue. lasted most of the day and they are gone now.
72 2021-01-24 weakness 1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after t... Read more
1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after the steroid shot, I started reactions---Severe headache, chills, nausea, cough, upper chest pain, severe weakness, blood pressure up and down. Went to family doctor 1/22 and covid shot in office showed negative. Worse on 1/24/21 and went to ED. They did a chest x-ray, CTA chest, lots of bloodwork and covid test that took 2 hours to receive results. All was negative except the D-dimer test. Thye thought it might be a result of the 2 injections within days of each other.
72 2021-01-24 seizure brought by EMS to ED; seizures at home in bed; 6 Epi and 1 bicarb; no hx of seizure
72 2021-01-24 pain in extremity chills, low grade fever, aches, pain in arm, slight nausea, headache started about 12 hours after re... Read more
chills, low grade fever, aches, pain in arm, slight nausea, headache started about 12 hours after receiving shot lessening after about 48 hours
72 2021-01-24 pain in extremity, cold sweat leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after inj... Read more
leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after injection & still have malaise and nausea. Had headache yesterday and day before. Also woke up at 3AM yesterday and day before in a cold sweat. Some leg ache today as well. Have been taking 2 extra strength Tylenol every 6 hrs which sometimes gives relief but not always.
72 2021-01-25 tingling At vaccine site, had numbness; tingling on lips and tongue on left side of face; tingling on left si... Read more
At vaccine site, had numbness; tingling on lips and tongue on left side of face; tingling on left side of face; headache/Mild headache; dizzy; exhausted; GI - mild naseau; intestinal discomfort; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL32216), via an unspecified route of administration on 09Jan2021 10:00 at SINGLE DOSE at arm left for covid-19 immunisation. Medical history included known allergies: yes. Concomitant medications included levothyroxine sodium (SYNTHYROID), lisinopril, fexofenadine hydrochloride (ALLEGRA), progesterone (PROMETRIUM [PROGESTERONE]), and "PULMICO". On 09Jan2021, it was reported that At vaccine site, had numbness, tingling on lips and tongue on left side of face. This has not subsided, sometimes spreading, waxing & waning. Same day - headache, dizzy, exhausted - two days. GI - mild naseau (nausea), intestinal discomfort - on going. Mild headache continuing. The patient did not receive treatment for the events. The outcome of the events was reported as recovering.
72 2021-01-25 pain in extremity her brain is going blank; back pain that occurs in her left leg past the knee until the top of her f... Read more
her brain is going blank; back pain that occurs in her left leg past the knee until the top of her foot; back pain that occurs in her left leg past the knee until the top of her foot; She wanted to know if it is like a sciatic nerve pain she is experiencing; she just thought it was swelling in her spine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left shoulder on 11Jan2021 at a single dose for covid-19 immunization. Medical history included other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, spinal stenosis, has a lot of back issues, like sciatic has a lot of problems. There were no concomitant medications. The patient had the COVID-19 vaccine on Monday (11Jan2021). On Tuesday (12Jan2021), she experienced back pain that occurs in her left leg past the knee until the top of her foot. She also mentioned that she had other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, and spinal stenosis. She wanted to know if the COVID-19 vaccine can cause the adverse event that she experienced. She wanted to know if it is like a sciatic nerve pain she is experiencing. The patient stated it may sound crazy, but she got the COVID 19 vaccine on Monday, she is 72 years old, and has a lot of back issues, like sciatic has a lot of problems, and she got the shot and Tuesday) morning, her back hurt so bad, down into her sciatic, into her butt, leg, her lower leg and as far as her foot, the top of her foot, and she doesn't know if this is something that was going to happen, she read about joint pain, tiredness, that would include joints in the back, she would expect. She wonders if she is out of her head, since it was the very next morning, this was Tuesday, and instantly, she was sitting with ice and trying to get ahold of her healthcare person, she gets pain shots in her back, but she hasn't had them in a couple years, she was going along pretty good, then this was bad enough, it is in her thigh and leg, and is always under her foot, and she just thought it was swelling in her spine. She wonders if it is a side effect or her imagination. When asked for address, the patient stated her brain is going blank. She stated this may be just her. She has bad back problems, and was going along pretty good, it has been a year or two since she has had any kind of anything. But this was a good one, a strong one, the ice hurts so bad. She woke up with it, it is staying the same- after having something like this, she was trying to get ahold of the pain clinic, to get a shot, but that may be 3-4 weeks out. She has had no blood work in a while. Outcome of the events "she just thought it was swelling in her spine" and "her brain is going blank" was unknown; while not recovered for other events.
72 2021-01-26 tingling PATIENT NOTED DIZZINESS AND TINGLING AND FAINTNESS MINUTES UPON RECEIVING VACCINE.
72 2021-01-27 pain in extremity, muscle spasms 1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day he... Read more
1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day headache, nausea, mind fog and imbalance, 6th day ulcers on my tongue, very painful for 3 days, severe crippling muscle cramps in my toes on my right foot during the night while sleeping. hives and red blotches. I didn't feel like myself for at least 12 days after the vaccine. I'm a little nervous about today, 01/28/2021, I took my 2nd dose this morning. Hope I don't have to report anything on the 2nd.
72 2021-01-27 bell's palsy DROOPING ON RIGHT SIDE OF FACE, EYE LID, RIGHT CHECK, RIGHT SIDE OF MOUTH, HEADACHE N SOME RIGHT EAR... Read more
DROOPING ON RIGHT SIDE OF FACE, EYE LID, RIGHT CHECK, RIGHT SIDE OF MOUTH, HEADACHE N SOME RIGHT EAR DISCOMFORT, EYE IRRITATION. CAT SCAN DONE AND ALL SHOWED OK AND THE FINAL OUTCOME ITS BELLS PALSY
72 2021-01-27 weakness, pain in extremity Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished m... Read more
Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished meal I started to get double over pain we went home and that took 15 min. The pain was sharp and continues for a total of 30 min. I payed down with heat pad then it went away .since then I feel very tired, no energy,and my arm still feels weak and sore after the first shot .today I go for the second one.
72 2021-01-28 weakness 12 minutes after receiving shot began to feel sweaty and light headed and like I was going to faint ... Read more
12 minutes after receiving shot began to feel sweaty and light headed and like I was going to faint - felt like something was going on with my heart.
72 2021-01-28 numbness, tremor Sever shakes and chilled to the bone. Fingers went numb with being so cold.
72 2021-01-28 pain in extremity awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt ... Read more
awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt woozy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration in the right arm on 13Jan2021 at 17:39 at a single dose in the hospital for covid-19 immunisation. Medical history included anxiety, seizures, and high cholesterol. She passed out last summer and they put her in the hospital from 31Aug2020 and ran all kinds of tests. In the end, they said she only had a few PVCs (premature ventricular contractions) and she doesn't need to see the doctor for a year. Mentioned she also has chronic bronchitis and this is related to having low platelet count and low immunity. All of these events predate treatment with Pfizer COVID 19 vaccine. Concomitant medication included amlodipine, atorvastatin for high cholesterol, clonazepam for seizures, escitalopram for anxiety, levothyroxine sodium for thyroid, and mirtazapine for sleep; all were ongoing. Stated that she had something weird happen after her injection about four hours after the shot. She received the first dose of the Pfizer COVID 19 vaccine on 13Jan2021 at 17:39 in the right arm. About three or four hours later on 13Jan2021, she was getting ready for bed and when she sat down and leaned over she had a god awful burning in her chest and nausea. She was going to take baking soda but when she sat up she had horrible pressure and pain in her chest and felt woozy so she sat on the floor and then the pain started to radiate through her arm and into her neck. The horrible pain and pressure in her chest felt like something was sitting on her chest and the bad pain in her chest was going into her arm and a little into her neck. She laid real still on the floor, and did a lot of praying, and then 20 minutes later it totally stopped. She got up slowly and finished getting ready for bed and was fine. She was just hoping they will still let her get the second shot. The whole event only lasted 20 minutes and when it was over it was completely gone. She did tell her husband when he came home. She was alone when this happened. The patient wanted to know if she can receive second dose of vaccine. She stated it almost felt like a heart attack. She was planning to get the second dose on 03Feb2021. Wanted to know if her effect will preclude her from getting the second dose of the vaccine. Outcome of the events was recovered on 13Jan2021.
72 2021-01-28 weakness pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like he... Read more
pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like her head is big; she didn't feel good; headache; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular on 14Jan2021 12:00 at a single dose on left arm for COVID-19 immunization. Age at vaccination: 72 years old. Medical history included hypertension, infection (term highlighted by the reporter: Yes; patient was admitted to a hospital from 29Dec2020 to 30Dec2020 due to infection), dyspepsia (reported as stomach, digestion), psoriatic inflammatory arthritis (she receives infusions for her arthritis once a month), sinus infection/sinus problems a month or two months ago, had cancer back in 1996 (had lumpectomy), stomach problems, and gastric endoscopy. Ongoing concomitant medications included losartan potassium, hydrochlorothiazide, omeprazole, and methotrexate. Other concomitant medications included folic acid, and plantago ovata (METAMUCIL). The patient had a regular flu shot a month ago (Dec2020). She can't remember when. The patient experienced headache on 14Jan2021. At the beginning, she had one, but then she got home, and the headache was like in the back of her head, like in her neck. She had pain all around her neck. She was feeling dizzy. She was able to sleep, however, the pain in her head is still there. She took aspirin along with her regular medication. When providing details, the patient made the comment that she can't think straight. She also has sinus problems, so she doesn't know if she has a headache from the sinus problems or because of the shot. She doesn't have a fever. She just feels like her head is big. She sees the date of when she is supposed to return for her second vaccine, 04Feb2021. She sees the lot number and then it has (name of center). The actual dose is unknown, she knows this is her first dose. She also receives infusions for her arthritis. She receives an infusion at a facility once a month, she used to receive it less than that, but her arthritis has been really bad, so she now does it once a month. She was supposed to go today but she didn't go because she didn't feel good. She had three COVID tests done because she had the sinus situation going on. A COVID test was done yesterday (14Jan2021) and it was negative. Another one was done when she had a gastric endoscopy on 09Dec2020. This test was also negative. She doesn't remember if she had another one in Dec2020 when she was at the emergency center, but all of her COVID tests have been negative. The patient has not recovered from headache. Outcome of the rest of the events was unknown.
72 2021-01-31 muscle spasms severe muscle cramps , muscle fatigue , low grade temp
72 2021-02-01 breast pain, pain in extremity her right arm began having a shooting pain that went up to her neck and left breast; her right arm b... Read more
her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; Indigestion; dry mouth; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982) via an unspecified route of administration on the left arm on 15Jan2021 at a single dose for COVID-19 vaccination. Medical history included ongoing heart murmur. There were no concomitant medications. She received the first dose of COVID vaccine on 15Jan2021 in her left arm. Patient stated that 15 minutes after receiving COVID vaccine her right arm began having a shooting pain that went up to her neck and left breast. She was given 4 Aspirin and a Nitroglycerin tablet. She was then transported to (Institute Name Withheld) by ambulance from vaccination facility. While at the hospital blood work was obtained and her pancreas was checked. Patient stated she was there for three hours. She would like to know if she should receive the second dose of the COVID vaccine? Reported she had an adverse event 15 minutes after receiving her first dose of the COVID-19 Vaccine. She said she had pain in her right arm. She said the pain went up to her neck. She said she had pain under left breast. She said she felt like she had indigestion. She said she was told to chew 4 aspirins, clarifying she was given 4 aspirins by the ambulance staff that was at the scene to treat her. Reported she was told her blood pressure was high. She said she doesn't know what her blood pressure reading was because the ambulance staff would not tell her. Reported she noticed she had a dry mouth while she was being transported in the ambulance to the hospital. Reported she was transported by ambulance to the hospital emergency room in (City Name Withheld), (State Name Withheld). She said she was treated and released from the emergency room. Reported her neck pain was gone first, but she still felt like she had indigestion while being treated in the emergency room. Treatment: Reported the hospital staff had her drink something, and then her indigestion, and arm pain went away. She said the hospital did blood work and checked her pancreas. She said she has no information on her blood work results, saying the emergency room doctor didn't share her results with her. She said the emergency room doctor only mentioned that he was checking her pancreas. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event pain in arm was recovered in 15Jan2021, patient recovered from neck pain, breast pain, indigestion and dry mouth in Jan2021; and unknown for the other event.
72 2021-02-01 facial pain she got it Thursday and that night she noticed a little itching/itching a little again in the palm o... Read more
she got it Thursday and that night she noticed a little itching/itching a little again in the palm of her hands; some face soreness; her BP was 152/85 that was high; she has to got the rash on her behind where she has been scratching; having an allergic reaction; a little puffiness on her lip; the cellulitis part of her skin; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247), via an unspecified route of administration on 14-JAN-2021 at the 72 years old at single dose for COVID-19 immunization. The medical history included COPD so sometimes she would cough, kidney stent, rheumatoid ("two" Tylenol and 20 mg prednisone for "her rheumatoid"). The concomitant medication was clarithromycin (MACROBID) from an unspecified date to 12Jan2021. The patient got it on the 14Jan2021. She says she had been doing fine she didn't know now. She was a retired paramedic so she usually felt things out, she got it Thursday and that night she noticed a little itching on 14Jan2021 but she did not think anything of it. Friday evening she had a good time eating some walnuts and she woke up about 2:30 itching that was Saturday morning before day, she took Benadryl and went back to sleep later then later on she was itching a little again in the palm of her hands and she just took a Benadryl and it went away. Then Sunday night, last night, she was okay so she decided to go to the pharmacy to get some Benadryl, they had no Benadryl and she only had old Benadry. Then about 12:30 she started itching on her bottom, itching on her arms and she was scratching. She noticed she was having some face soreness in Jan2021 but she was using some expired facial cream so she thought that was why her face was sore so she put some hydrocortisone cream on it. Since she was itching she decided to take a little of her nieces Benadryl, it is pediatric Benadryl. She was itching so she called her doctor and she heard him in the ER say they had too many people in there to tell her to go to the ER so she said okay. She hung up and called the pharmacy and they said it sounds like having an allergic reaction in Jan2021 and she told him she had the COVID vaccine but she doesn't think she was short of breath and she gave them her vitals her BP was 152/85(BP 157/85) that was high for her in Jan2021, but it came down, she took some Tylenol then it was 146/77, her pulse rate was 77 and her respirations were good she did not have shortness of breath or cough well she has COPD so sometimes she would cough. Then she got up and said let me go one over and get some Benadryl so she went by there got some good Benadryl and she thought she would call and see what they think about all this. She took the Benadryl at 10:25 and she is doing okay right now but she had whelps, she has to got the rash on her behind where she has been scratching in Jan2021, it is on the left side of her hip, the cellulitis part of her skin that is mostly where she is itching in Jan2021. She remembers when she worked at the health department they would give Benadryl and Prednisone. She thought if the Benadryl does not help then she would call, then she decided she would go ahead and call to see what information they have. She says Pfizer is giving her alerts that she has been answering but she did not have the itching at that time. She retired from being a paramedic in 2009. She says she is 72 now but she woke up in 1985 and her lip was swollen like not totally swollen but her top lip was swollen more than the bottom in Jan2021. They gave her an Epinephrine shot and Benadryl and she is just wondering if this itching is related to the vaccine or if it is just an allergy that she may have come up on or something like to the walnuts or something. She says they went there and they gave the shot and they gave Benadryl but they are not sure. She said the doctor never figured our what it was that cause it and it never happened again until she did notice a little puffiness on her lip again this morning. She said the itching first started around 2:34 AM in the morning before light. It had improved since taking up to date Benadryl. She was supposed to get her second dose 04Feb2021. She didn't want COVID 19. She knew she just came off, she had a kidney stent and she had stopped taking 2 days before, she was taking Macrobid. She was not taking that right now. She took a lot of other medications but the Macrobid she was just on and it was stopped on Tuesday 12Jan2021, 2 days before the vaccine. She didn't know if the Macrobid would interfere with getting vaccine. The outcome of the event itching was recovering, the other events was unknown.
72 2021-02-03 pain in extremity Fatigue, headache, chills, aches in extremities.
72 2021-02-03 burning sensation itching and burning sensation around the face, ears and arms and continued down the back, legs to th... Read more
itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet; itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet; This is a spontaneous report from a contactable health professional, the patient. A 72-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3246), via an unspecified route of administration in the left arm on 20Jan2021 at 11:45 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no known allergies. The patient was not diagnosed with COVID prior to the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 20Jan2021 at 23:30 (the evening after receiving the first dose), the patient experienced an itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet. The patient was treated for the events with 1 tablet of expired diphenhydramine (BENADRYL), one to one and a half hours after which the symptoms started to improve and by 02:00 the patient was able to get some sleep. Since the vaccination, the patient was not tested for COVID. The clinical outcome of "itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet" was resolved on 21Jan2021.
72 2021-02-03 pain in extremity positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt ... Read more
positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt lethargic and had a dull headache; Her arm hurt the night of the vaccine and the following day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient) reported similar events for two patients (patient's husband and patient). This is the first of two reports. A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot EH9899), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. Medical history included cholesterol. Concomitant medication included pravastatin sodium (PRAVACOR) for cholesterol, levothyroxine sodium (SYNTHROID), she had been taking both at least 10 years and were ongoing. The patient experienced her arm hurt the night of the vaccine and the following day since 04Jan2021. She had been tested a few times. Tested in (state) and then came to (state). Quarantined for two weeks and test were negative. She had COVID testing on 11Jan2021 and got results were 13Jan2021. She experienced positive for covid on 11Jan2021, cough and she felt lethargic and had a dull headache on 06Jan2021, she had a mild case, did not have a fever, she went to the walk in clinic, had lungs checked, her oxygen level was normal, she had been testing normal, she did not have any severe symptoms of the COVID, she got post nasal drip and She started Azithromycin on 11Jan2021. The patient was such a careful person. When she went to the supermarket, she wore a shield, mask, and gloves. She did not socialize, was home body. She had no idea how she got it. She did call her internist when she found out she had it. The patient underwent lab tests and procedures which included oxygen level: normal in Jan2021, oxygen level: good on an unknown date, COVID test: negative on an unknown date, COVID test: positive on 11Jan2021, lung checked: clear in Jan2021, testing: normal in Jan2021. The even outcome was unknown.
72 2021-02-04 flushing 1333- Patient complaint of ?feeling flushed in my chest, like reflux?- vital signs 130/94, P-72, O2 ... Read more
1333- Patient complaint of ?feeling flushed in my chest, like reflux?- vital signs 130/94, P-72, O2 sat 99%; Patient states that she has hypertension and cardiovascular disease. States she has taken her meds today and BP?s are well controlled. Vitals taken and patient offered oral fluids. Patient observed for any additional complaints- none offered. Able to verbalize throughout assessment. By 1345 she states that she is feeling fine and episode has passed. She stated she thinks she was just very anxious. Patient instructed to seek emergency care after departure if need arises- patient verbalized understanding.
72 2021-02-04 flushing, feeling hot 72 y/o Female with sudden onset of "hot" feeling with flushed feeling. No shortness of breath, wheez... Read more
72 y/o Female with sudden onset of "hot" feeling with flushed feeling. No shortness of breath, wheezes, stridor, nausea/vomiting, or near syncope. Pt was placed in chair and observed. Vital signs: BP 138/84, HR 72, Resp. 16, Room air O2 99%. Symptoms resolved spontaneously. Pt observed x 30 min.
72 2021-02-04 burning sensation, tremor, tingling Five minutes after taking the vaccine, patient c/o facial burning, face turning red, facial tingling... Read more
Five minutes after taking the vaccine, patient c/o facial burning, face turning red, facial tingling, and feeling shaky. Admin Benadryl 25 mg PO. Patient c/o tongue numbness. B/P 180/94. HR 70;. EMS arrived for transport but patient declined. Symptoms resolved. F/U with patient confirmed that she went to ER. Admin Decadron
72 2021-02-04 weakness Headache, fuzziness, and overall weakness that kept me in bed for 1 1/2 days. No fever. Took Tylenol... Read more
Headache, fuzziness, and overall weakness that kept me in bed for 1 1/2 days. No fever. Took Tylenol and Metamizole..
72 2021-02-04 tingling Itchiness, tingling around lower lip. Bilateral arm tingling and lightheadedness. BP 125/74, pulse 6... Read more
Itchiness, tingling around lower lip. Bilateral arm tingling and lightheadedness. BP 125/74, pulse 64; refused Benadryl.
72 2021-02-04 pain in extremity arm hurt; This is a spontaneous report from a contactable consumer, the patient. This 72-year-old fe... Read more
arm hurt; This is a spontaneous report from a contactable consumer, the patient. This 72-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EH9899, Expiration date: 31Mar2021), first dose, via an unspecified route of administration in the left arm on 28Dec2020 at 09:30 (at 72-years-old) as a single dose for COVID-19 vaccination. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included famotidine (FAMOTIDINE), tiotropium bromide (SPIRIVA), latanoprost (LATANOPROST), timolol (TIMOLOL) and loratadine (LORATADINE). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the patient experienced arm hurt. The event did not require a visit to physician or ER. The outcome of the event arm hurt was resolved on 29Dec2020.
72 2021-02-04 pain in extremity body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a sponta... Read more
body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the right arm on 16Jan2021 at 18:15 at a single dose for COVID-19 immunization. The vaccination facility was a public health department. The vaccine was not administered at the Military facility. The patient had no additional vaccines administered on the same date of the Pfizer vaccine. Relevant medical history included gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. The patient had no family medical history. Concomitant medication included cimetidine for GERD, which she had been taking for years and years. The patient had no other vaccinations within four weeks prior to the first vaccination. The patient woke up on Tuesday, 19Jan2021, feeling off; she experienced body aches, joint pain, and fatigues. The symptoms (Sxs) were still ongoing. The patient had question regarding the side effects and duration: if these had been reported and was it normal to still feel the side effects and how long would it last for. The patient was also asking if these were indicative of something more serious. The patient added that her healthcare provider (hcp) told her to take 2 paracetamol (TYLENOL) every 6 hours; however, the Tylenol only lasted for 5 hours. The patient further asked that if she continued to have side effects, at what point should she be do something and wanting recommendations on management. The patient was also asking if the side effects would happen with the second shot. The patient further reported that she felt pretty good on Sunday and Monday (17Jan2021 and 18Jan2021), maybe just a little off, and stated that on Tuesday (19Jan2021), she woke up and started with the classic side effects body aches, joint pain, fatigue, and chills that had continued. She stated she was taking Tylenol 2 extra strength; it worked for about 5 hours and then the effects came back. The patient wanted to know if this was normal to last this long and had this been reported by others. She stated she had contacted her doctor and her doctor did not know. The adverse events did not require any visit to an emergency room or a physician office. Therapeutic measures were taken as a result of body aches/ body and legs aches, joint pain, fatigues, and chills. There were no relevant tests. The patient was not recovered from the events "body aches/ body and legs aches, joint pain, fatigues, and chills."
72 2021-02-05 facial paralysis Patient experienced slight facial drooping and it went away after 2 hours. Cleared for second vaccin... Read more
Patient experienced slight facial drooping and it went away after 2 hours. Cleared for second vaccine by site MD
72 2021-02-05 slurring Pfizer-BioNTech COVID-19 Vaccine EUA Laughing uncontrollably, slurring of words, headache, foggines... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Laughing uncontrollably, slurring of words, headache, fogginess. Event lasted about one hour.
72 2021-02-07 muscle twitching 14 hours after the injection I woke up and my teeth were hitting each other. I was not cold or hot. ... Read more
14 hours after the injection I woke up and my teeth were hitting each other. I was not cold or hot. Within a few minutes my body muscles began twitching uncontrolably. My arm,, legs,, jaw were all fluttering.. This lasted for one hour.
72 2021-02-07 tingling Approx 7 minutes after receiving the vaccine, client started c/o tingling in her left hand and the t... Read more
Approx 7 minutes after receiving the vaccine, client started c/o tingling in her left hand and the tip of her tongue. Vitals monitored, oxygen applied per nasal cannula. Her symptoms resolved very quickly without the use of medications. She also c/o metallic taste in her mouth. She was upset bc she had to wait 2 hours to get the shot and then had to be monitored for 1hr and 45 minutes after the vaccine. She did have one previous reaction to a pain shot in the past.
72 2021-02-07 pain in extremity Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip f... Read more
Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip floppy; Dizzy/ had the dizziness which was severe; Falling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), via an unspecified route of administration on 20Jan2021 at 08:00 AM at single dose because she would like to not get Covid 19. Medical history reported as no. Concomitant medication included levothyroxine. The patient reported that she had bnt162b2 shot on Wednesday the 20Jan2021 about 8 O'clock in the morning, no real problem when she had it, had little bit sore arm but this morning (in Jan2021) about 2 O'clock she woke up, was not able to sleep, moved around a bit, her heart was doing kind of flip floppy, was not thinking much, the next thing she knew, she was extremely dizzy and she passed out, patient was asking could that be a side effect of Covid 19, it was about 36 hours after she had the shot. Patient also stated falling and passing out kind of get you off key. She had the dizziness which was severe and did pass out in Jan2021. No investigation assessment. No treatment was received for the events. The outcome of the events was unknown.
72 2021-02-09 burning sensation On my drive home, my face started burning. When I arrived at home the burning increased with redness... Read more
On my drive home, my face started burning. When I arrived at home the burning increased with redness I reported this information on Tuesday 1/26/21 to the provider of the vaccine. I was told to take Benadryl which I did immediately. On Wednesday, I continued to take Benadryl every 4 hours. On Thursday, my face continued to burn with redness and a rash. I then started to get a low grade fever and it appeared my face was swelling and then we decided to go to Urgent Care. The Doctor said my face was swollen and gave me a 1/2 dose of a steroid shot and a prescription for steroid pills. I saw my Primary Care Doctor 2/8/21 and he said I should not get the second dose of the vaccine.
72 2021-02-09 weakness Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, chills, nausea, vomit, feeling unwell, di... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, chills, nausea, vomit, feeling unwell, dizziness and weakness
72 2021-02-09 flushing, feeling hot Within 20 minute of receiving the shot my face was very flushed and hot; Within 20 minute of receivi... Read more
Within 20 minute of receiving the shot my face was very flushed and hot; Within 20 minute of receiving the shot my face was very flushed and hot; lips slightly swollen; Mild itching on face continues 20 hours later; This is a spontaneous report from a contactable consumer reporting for herself. A 72-years-old non-pregnant female patient received BNT162B2 lot number unknown, via an unspecified route of administration on 22Jan2021 15:45 (at the age of 72-years-old) as a SINGLE DOSE in the right arm for covid-19 immunisation. Medical history was none. It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications were none. The facility where the most recent COVID-19 vaccine was administered was provided as other. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Within 20 minutes of receiving the shot, the patient's face was very flushed and hot, lips slightly swollen on 22Jan2021 16:00. Mild itching on face from unspecified date in Jan2021 continues 20 hours later. No treatment was received for the events. The clinical outcome of within 20 minute of receiving the shot my face was very flushed and hot was not recovered It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
72 2021-02-09 feeling hot raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took m... Read more
raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took my temperature and it was 97.4; My heart rate jumped to 93bpm; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via an unspecified route of administration on 22Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. The patient medical history included hypothyroidism, inflammation and sensitive to grains. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient was not pregnant at the time of vaccination. Approximately 4 hours after patient received the vaccination (22Jan2021 21:45), she felt very warm, and she started itching. Patient developed a rash all over the trunk. Patient took her temperature and it was 97.4. Patient heart rate jumped to 93bpm. Patient took a diphenhydramine hydrochloride (BENADRYL). As soon as the diphenhydramine hydrochloride took effect, her heart lowered pretty quickly. When patient woke up this morning (23Jan2021), she was still itching mildly and raised welts if is scratched. More diphenhydramine hydrochloride four hours ago. Treatment received for the adverse event included diphenhydramine hydrochloride (self administered). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovering. The events were reported as non-serious.
72 2021-02-10 inability to speak Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue... Read more
Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated "I was completely aware though a little "foggy". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came. Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned." Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
72 2021-02-10 weakness caller ( admitting physician) stated pt got the vax and then she got weak on 1/26/2021. Stated he f... Read more
caller ( admitting physician) stated pt got the vax and then she got weak on 1/26/2021. Stated he felt like she was lifting weight blocks. She went to Medical Center ER and was discharged and fell and in the parking lot. Pt came back to same ER 2 days later and was admitted w/ Guillain-Barre dx. Pt was then treated with IV Immunoglobulins. Labs; Sodium 132. BUN7 , Albumin 2.7, Glucose 112, WBC 3.5 HGB 10.4
72 2021-02-21 flushing Patient received vaccine at 10:23 am and parked and instructed to wait 30 min due to prior reaction ... Read more
Patient received vaccine at 10:23 am and parked and instructed to wait 30 min due to prior reaction to bee stings. At 10:47am patient reported feeling a flushed and reddened face, "blurry eyes", and lightheadedness. Assessment VS as follows BP 150/70 HR 70 - SR skin- warm and dry SpOx-99 % This reaction was not like a typical bee string reaction. She denies restricted airway and throat tightness. Talking in a normal rate and rhythm. Advised patient that we will call EMS for transport to a higher level of care, however patient refused. This patient was instructed to remain onsite for further observation and she agreed. She was accompanied by her spouse who was the driver. She reported that she will return home and take benadryl or the epi-pen if condition worsens. She will contact her doctor and report her experience today. Patient felt recovered and decided to leave after 30 additional minutes.
72 2021-02-21 tingling, numbness, tremor Pfizer-BioNTech COVID-19 Vaccine EUA: immediately after receiving vaccination patient reported dizzi... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: immediately after receiving vaccination patient reported dizziness, tremors, diaphoresis, and numbness and tingling of legs. Medical emergency team called to evaluate patient. Vital signs checked four times throughout observation period and all were within normal ranges. Patient's symptoms improved with food and juice and able to leave vaccine clinic for home asymptomatic and stable.
72 2021-02-21 weakness, hot flush the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredne... Read more
the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
72 2021-02-21 tingling tingling on top of her ears, headaches, possible rash on top of her hands that resembled prior histo... Read more
tingling on top of her ears, headaches, possible rash on top of her hands that resembled prior history of contact dermatits
72 2021-02-22 tingling Patient at Covid vaccine drive up clinic Patient with multiple medication allergies-confirmed with ... Read more
Patient at Covid vaccine drive up clinic Patient with multiple medication allergies-confirmed with patient Allergies Allergen Reactions ? Levaquin [Levofloxacin] Hives ? Percocet [Oxycodone-Acetaminophen] Nausea and Vomiting ? Amoxicillin Nausea and Vomiting ? Bactrim [Sulfamethoxazole W-Trimethoprim] Other dizziness ? Hydrocodone-Acetaminophen Other ? Keflex [Cephalexin] Other Severe vertigo ? Norco [Apap-Fd&C Yellow #10 Al Lake-Hydrocodone] Nausea and Vomiting ? Oxycodone Nausea and Vomiting ? Tramadol Nausea and Vomiting patient reported tingling of face and lips after receiving vaccine @1630 States lips appeared more swollen then prior to vaccine Denies shortness of breath, wheeze, tongue/ throat swelling, chest pain, palpitation OBJECTIVE: Blood pressure :138/ 78 HR 77 Oxygen saturation 99% on room air Gen: sitting in car. No acute distress Eyes: Conjunctivae and sclera without injection/icterus and lids and lashes normal. Oropharynx moist and intact without lesions. HENT: Atraumatic. No facial droop. Minimal swelling of right upper lip without erythema. Oropharynx moist and intact without lesions. Neck: supple Pulm: No tachypnea, retractions or cyanosis. clear to auscultation bilaterally with symmetric air entry in all fields. Speaking in > 5 word sentences without difficulty. CV: regular rate and rhythm Psych: Speech fluent with normal volume, rate, and pitch alert and oriented x iii,pleasant affect/mood. Skin: Exposed areas warm,dry, without rash or jaundice ASSESSMENT/PLAN: 1. Tingling of face and lips 30 minutes after receiving Covid vaccine. No evidence of hypoxia or respiratory distress/ hemodynamic instability. Patient with history of multiple allergies to medications. Benadryl 25 mg orally x1 given @ 1640 Lot 201666 Exp 04/2023 Reassess in 15-20 minutes Addendum Reassessed at 1700 Patient reports increased swelling/tingling to lips and face right > left Denies shortness of breath, wheeze, difficulty swallowing , itching, hives Exam Gen: sitting in car- appears comfortable Eyes: Conjunctivae and sclera without injection/icterus and lids and lashes normal. HENT: Atraumatic. No facial droop -increased swelling to lips/ perioral right > left -mild erythema periorally -Oropharynx moist and intact without lesions. Neck: supple Pulm: No tachypnea, retractions or cyanosis. Speaking in > 5 word sentences without difficulty Psych: Speech fluent with normal volume, rate, and pitch alert and oriented x iii,pleasant affect/mood. Skin: Exposed areas warm,dry, without rash or jaundice ASSESSMENT/PLAN: 1. Increased edema and patient reports increased tingling of lips/ face ~ 60 minutes after receiving Covid vaccine. Not improved with benadryl 25 mg x1. Concerning for allergic reaction with history of multiple allergies. Urgent Care to continued monitoring and treatment Patient agrees Husband will transport via private care Urgent Care notified by clinic: Patient given EpiPen in case symptoms return. Instructed patient to go directly to the emergency department for any tongue swelling lip swelling trouble breathing or need to use of EpiPen. Patient is asymptomatic. Patient has additional Benadryl or will pick up from the pharmacy.
72 2021-02-22 numbness after 1 hour feeling light headed, felt drunk for 7 hours, elbow stiffness on right arm, numbing fee... Read more
after 1 hour feeling light headed, felt drunk for 7 hours, elbow stiffness on right arm, numbing feeling on right arm, fingertips numbness
72 2021-02-22 discomfort, hot flush angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy... Read more
angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy; muscle aches and heaviness; muscle aches and heaviness; she just woke up feeling sick; fevers may come like a hot flash; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown), via an unspecified route of administration on 23Jan2021 at a single dose, in left arm for COVID-19 immunization. Medical history included fibromyalgia diagnosed years ago, angina (some stents). There were no concomitant medications. On Jan2021, the patient experienced angina, fever, chills, cough, sore throat, runny nose, nausea, diarrhea, headache, arm heavy, muscle aches and heaviness, and she just woke up feeling sick. The patient experienced multiple AEs after 1st dose of vaccine (received on 23Jan2021). The patient experienced angina later last week. Clinical course: The patient has misplaced card, states her second appointment for the second dose is this Saturday. Caller stated she started having these experiences the day after she was vaccinated with her first dose, received first dose of 23Jan2021. She had fevers, chills, cough- not an aggressive cough, a funny kind of sore throat- like something wrapped around her throat like the muscles of her throat, no congestion but does have a runny nose, states she has some nausea, no vomiting but feeling like she needed to vomit and diarrhea, and headache. The symptoms started about the third day after the vaccine, started with the fevers, stated the fevers may come like a hot flash, lasts seconds even, states you know it is a fever because your bones get hot. These symptom's did not attack her body at one time. Her whole arm stayed heavy, the whole arm not just the injection site, for almost 10 whole days. She previously had fibromyalgia and thought maybe that made the symptoms worse. She had muscle aches and feeling heavy. Her symptoms were spread out over time, no two were at the same time, sore throat was one of the last things. Diarrhea was ongoing, not a runny diarrhea but it was enough to empty stomach and was soft. She was a medic in the military, worked as a Nurse, clarifies she was an LPN and took all the underlying courses to be a PA. One of the issues she found, she thought it may be deadly, as a prior healthcare person and in tune to her body, the people who are in the nursing homes may not be mobile, states so one of the things she felt was just feeling really really sick, that she couldn't put a pin point on it, states she just woke up feeling sick, states she had the urge to get out of bed and got up and after she got up the feeling left her, states a person in the nursing home may just feel really bad and cannot get up, thinks a protocol should be that the people that are immobile should be required to move or if they can't get up they need to move their muscles, people with these symptoms need to get up and get moving. She also has history of angina and a stent, has not had angina in a while and had 3 days where she thought she may need to go talk to her doctor. It was on Wednesday, Thursday and Friday this week. States one of her friends, 92 years old, said she got high after the vaccine and didn't want to talk to anybody, states it was her first dose, she was kind of leery about the 2nd shot, feels like this was kind of aggressive. She had both doses and had no symptoms, but 92-year-old female had no symptoms right away, other than normal body aches and pains, but the next day was high as a kite. Her son has heart disease and she advised him not to take it right now. They were losing a lot of people to the vaccine in nursing homes, no further information provided. This could be affecting good hearts more than damaged hearts, read that this virus likes to work in parts of the body that are already damaged. The outcome of event diarrhea was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, a causal association between the reported angina and BNT162B2 cannot be completely excluded. Note however, that the patient has underlying angina with some stents that may also have contributed to the event. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
72 2021-02-23 pain in extremity Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. F... Read more
Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. For two days
72 2021-02-23 pain in extremity My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged ly... Read more
My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged lymph nodes and the lymph nodes under my arm has been very, very sore. I've had fevers, chills and fatigue. My stomach has been upset since the vaccine and my appetite has been decreased.
72 2021-02-23 weakness Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pa... Read more
Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pass out." Patient had not eaten since yesterday. Given orange juice. Patient began experiencing slight altered mental status (appeared to be losing consciousness in-and-out). EMS treating patient and transported patient to ED.
72 2021-02-23 tingling Pt left tent 13 to observation lane. Pt. was complaining of tingling hands. Paramedics monitored u... Read more
Pt left tent 13 to observation lane. Pt. was complaining of tingling hands. Paramedics monitored until symptoms subsided. Paramedics released pt. to leave.
72 2021-02-23 tremor, weakness feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; he... Read more
feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; her eyes start feeling funny and burning when she has a fever; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of 2 reports. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at the right upper arm close to the shoulder on 02Feb2021 07:30 at single dose as she doesn't want to get COVID again or give COVID to anyone else. Medical history included metabolic syndrome from 1994 and ongoing, it all started when she was 46 and it runs in her family and it was a genetic thing; ongoing diabetes mellitus, was diagnosed when she was 65, so 7 years ago; she had COVID in Nov2020 but it was just a very mild case and she just had a cough; and cardio artery problems. She takes a lot of medications and she has metabolic syndrome which includes cardio artery problems and diabetes, but she has taken all of those medications for a long time. The patient says she was calling to report a couple little concerns she has. She received her shot on Tuesday, 02Feb2021 at about 7:30 in morning and her arm started at about 2 to 3 in the afternoon and she noticed it was getting sore, but it was no big deal, she did not think anything of it, and on the second day she thought that was it and she was over it on 03Feb2021. She states her husband also mentioned that he had soreness in his arm after his vaccination. She says at three in the afternoon on 03Feb2021, she started feeling weak and shaky, but she didn't think much of that. She says this began around 3 to 4 when yesterday afternoon, 03Feb2021, she had a fever. She says she took her temperature and it was 100.4 and that all kind of was gone by the evening but when she woke up this morning, she was weak and shaky again. Today she got up and was weak and shaky and it never left, she was still weak and shaky. The patient mentions that she was diabetic so she can get weak and shaky when she needs to eat something, but she had just eaten, and she ate yesterday so she doesn't think it was caused by that. The patient says she thinks we should know that she was diabetic. She says then she could tell that she had a fever, so she took her temperature and it was 100.4 which for her was high. She states she didn't even have a fever when she had COVID. The fever began yesterday afternoon (03Feb2021). She says her eyes start feeling funny and burning when she has a fever and they felt that way so that's why she took her temperature. This was the highest it has been in years. She says last night she took her temperature again and the fever had gone away in 30 to 40 minutes, so she thought it was over. She took her temperature again before she called this morning, 04Feb2021 and it was 99.2, which was still a little hot for her. She says for her that's a fever. She was 96 and 97 usually. The patient says she still feels like she has a little fever. She was not someone who usually has a fever and it can be just a little bit of a fever for instance like this morning when she was 99.2. Her eyes were still feeling funny and burning this morning and that was why she took her temperature this morning. The outcome of the event arm was a little sore was recovered on 03Feb2021; feeling weak and shaky was not recovered; fever and her eyes start feeling funny and burning when she has a fever was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162089 Same reporter/drug, similar event, different patient
72 2021-02-23 flushing high blood pressure and flushed; 152/90
72 2021-02-23 weakness pt states that the next day after her vax she had weakness, chills, fatigue and she still has these ... Read more
pt states that the next day after her vax she had weakness, chills, fatigue and she still has these symptoms. Pt states that the injection site hurt for just a few days. Pt contacted her PCP regarding her symptoms and was told not worry about them at this time but has an appt next week for an annual check up and will FU w/ her about this at that time.
72 2021-02-24 feeling cold I was feeling chilly and I went to bed early and got under the covers. At 3 in the morning, I had a ... Read more
I was feeling chilly and I went to bed early and got under the covers. At 3 in the morning, I had a fever - 99. something and aches and pains. I took ibuprofen. I got up at 7:00 am and my temperature had gone up to 100 something. My body ached really bad. It ached all day long ( and fever continued) and it felt like I had a really bad flu. I called my doctor (telemed appt) and she thought it would be over by 24 hours. It did go away after 24 hours.
72 2021-02-24 tenderness Left axillary (ipsilateral) adenopathy with tenderness. Advised symptomatic treatment due to tender... Read more
Left axillary (ipsilateral) adenopathy with tenderness. Advised symptomatic treatment due to tenderness (OTC acetaminophen, warm packs) and monitoring for resolution. No evidence of local or systemic infection.
72 2021-02-24 tingling Light headed and dizziness, left side headache tingling sensation down entire left arm to finger t... Read more
Light headed and dizziness, left side headache tingling sensation down entire left arm to finger tips, and up to chin neck and chest area for about 20 minutes
72 2021-02-24 facial paralysis, numbness Right eye will not blink closed; numbness on the right side of face, lip; and right side of mouth is... Read more
Right eye will not blink closed; numbness on the right side of face, lip; and right side of mouth is turned down.
72 2021-02-25 weakness None for first injection. Second injection started with extreme chills, moved to headache, muscle ac... Read more
None for first injection. Second injection started with extreme chills, moved to headache, muscle ache, weakness. Lasted 24 hours, mitigated with Tylenol. 10 days later, still suffering intermittent fatigue, weakness, inflamed lymph node near left breast, diarrhea and muscle ache.
72 2021-02-25 numbness, tingling Patient experienced shortness of breath and bilateral extremity numbness and tingling since receipt ... Read more
Patient experienced shortness of breath and bilateral extremity numbness and tingling since receipt of recent COVID vaccination.
72 2021-02-25 facial pain pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms... Read more
pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms, hands and knees, a splitting headache, also had pain in her ears, face, and upper back. Next day the pain was worse. Pt contacted her PCP and was told to report to VAERS. She still has pressure in her head, eye, ear ache and cant do regular every day activities.
72 2021-02-26 tremor Developed nausea and vomiting after her COVID vaccine earlier today. Associated with chills and trem... Read more
Developed nausea and vomiting after her COVID vaccine earlier today. Associated with chills and tremors. These improved 45 minutes ago. Poor PO intake. No abdominal pain. COVID, flu negative. Mild systemic vaccine reaction. Zofran given and rx. Advised patient to speak with her PCP before considering second COVID vaccine.
72 2021-02-28 tingling, flushing, cold sweat Approx 5 minutes after receiving the vaccine client started c/o tingling, clammy, flushed apperaranc... Read more
Approx 5 minutes after receiving the vaccine client started c/o tingling, clammy, flushed apperarance. States she is on beta blockers and gets light headed often. no medications given. Client recovered quickly. This information was obtained by her daughter. She denies any problems with her first dose, and only thing now is some soreness in her shoulder.
72 2021-02-28 weakness I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in gener... Read more
I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in general I feel like I have been poisoned.
72 2021-02-28 weakness Sleepy and weakness. Drunk like sx at 1900 hr. Currently very tired. Steady gait.
72 2021-02-28 migraine Too long to have muscle pain from a shot; Migraine headache; severe arm pain where the shot was inje... Read more
Too long to have muscle pain from a shot; Migraine headache; severe arm pain where the shot was injected; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261; expiration date not provided), via an unspecified route of administration from 21Jan2021 to 21Jan2021 at SINGLE DOSE for an unspecified indication. Medical history included 'thyroid' from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine from an unspecified date and unknown if ongoing at 100 ug, 1x/day for 'thyroid'. Patient stated that she spoke with her physician's assistant. Patient received vaccine on the 21st of January, the first shot at her local place. The following morning at 4 in the morning, patient had severe arm pain where the shot was injected. So patient put a hot compress on it and took some paracetamol (TYLENOL). Patient mentioned that it didn't relieve for about an hour and a half. Patient meant the pain was really severe but finally it went away. The next day, it came back again and then the patient did it again and the pain keep coming back. Patient stated "And now it's been tomorrow will be a week. And that's too long to have muscle pain from my shot". Patient also mentioned that second day after the shot, migraine headache started. Patient stated, "Now I get them, but I only get them in the spring and I get them in the Fall. I don't get the migraine headaches in the winter time. I could only take Excedrin Migraine for the migraine, it's just over the counter medicine. And so I took that for the headache but those have not gone away either. When patient contacted her physician's assistant just now, it was reported that patient the physician's assistant is going to write a prescription for a muscle relaxer. Patient also reported that she is not going to take that second shot as she didn't know where to go to cancel it but she is not taking it. Patient mentioned she can't have pains like this. Patient stated that she can't tolerate pain to begin with, let alone have excess pain in her system. Patient added that she doesn't take medications. She is only on a thyroid medication (later confirmed the name as levothyroxine). Patient confirmed that the vaccine was Pfizer COVID-19 vaccine. When probed for the due date of the next shot, patient stated 'February 11th at 12 o' clock'. Patient also stated 'I am not getting it, I am not taking the second shot. I didn't get you, I don't know what you said. I am not understanding you. I am not getting what you are saying. I am not taking the second shot, it is scheduled for February 11th of 2021, I am not taking it. Because they called and asked if I wanted to receive it and my age is almost 73. So, I thought I probably should give it a chance. But now with the reaction I don't want the second one' and 'I don't know if there is something wrong with this phone or something wrong with the connection, I don't understand, I get part of it but I don't understand the other part. It blanks out, I don't know what's wrong, you are asking me something, but I don't know what it is'. Patient also reported that the pain started the day after she got the shot, 22Jan2021. Patient is still having pain. Patient also confirmed that TYLENOL was the treatment for pain but it was not working. Medication for migraine was reported as EXCEDRIN migraine. Patient further confirmed EXCEDRIN Migraine did not help with the migraine and stated 'No, I still have it, it gives me some relief but then after wears off it comes back, the migraine comes back'. Patient further added "Okay, I am just going to rely on my physician assistant, she has got some medication ordered for me, a muscle relaxer. And I am going to try that and see if that will make everything go away". Outcome of the events 'severe arm pain where the shot was injected' and 'migraine headache' was not recovered; outcome of the remaining event was unknown.
72 2021-02-28 pain in extremity fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain o... Read more
fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain onset 12 hours after receiving the vaccine ongoing at this point
72 2021-03-01 weakness Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating m... Read more
Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating much; Achy; This 72- year-old female patient contactable consumer (reported for herself) received the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EL9265; expiration not provided), via an unspecified route of administration, on 28Jan2021 at 09:15 AM (at the age of 72-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital. Medical history included: COVID in Mar2020 and was hospitalized for 10 days, hypertension, thyroid disorder, and flu shot. Concomitant medication included: Hydrochlorothiazide 12.5 mg, once a day for blood pressure and medication for thyroid reported as: "NP" 0.5gms. On 28Jan2021 later on after vaccine, she reported 9:15 pm that she did not feel good. She had chills, fever, headache, did not feel like eating much, was achy, and not feeling very energetic. During the night temperature was 101.4. At 8 in the morning, I started taking 2 Tylenol, 500 mg and it went lower but then it would come back up, so I take more. So, it never went over 101.8. now here we are on the Saturday morning and I am not feeling very energetic and I still have just a 99 temperature. Treatment included: Tylenol. The clinical outcome of the events I did not feel good, chills, fever, headache, did not feel like eating much, Not feeling very energetic, and Achy were unknown. No follow-up attempts are possible. No further information is expected.
72 2021-03-01 tremor SOB, weakness, bilateral trembling, feeling sleepy, evaluated by EMS-cleared
72 2021-03-02 pain in extremity, discomfort Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash ... Read more
Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared day after injection as well as burning. Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
72 2021-03-02 tingling In observation patient noticed a new onset of tingling and itching on her upper extremities. Admini... Read more
In observation patient noticed a new onset of tingling and itching on her upper extremities. Administered benadryl with no relief and subsequently given epi pen. Patient has prior allergy to flu and pneumonia vaccine. Advised by PCP to take benadryl prior to COVID vaccine which patient took. Patient presented to ED subsequent day as itching continued. No lip swelling or tongue swelling or difficulty breathing.
72 2021-03-02 pain in extremity Pain in arm; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-o... Read more
Pain in arm; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: 1284, expiration date was unknown), via an unspecified route of administration in the left arm on 07Jan2021 at 16:00 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was the hospital. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jan2021 at 16:00, the patient experienced pain in arm, which was still bad after more than 3 weeks. The patient assessed the event as non-serious. Therapeutic measures were taken as a result of pain in arm, which included paracetamol (TYLENOL) or ibuprofen (ADVIL). The patient was not recovered from the event.
72 2021-03-02 weakness Throwing up, falling from weakness.
72 2021-03-02 pain in extremity abdominal cramping; diarrhea; sore arm day of injection (dose 2); This is a spontaneous report from ... Read more
abdominal cramping; diarrhea; sore arm day of injection (dose 2); This is a spontaneous report from a non-contactable consumer (patient). A 72-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration at arm left on 16Feb2021 at single dose for COVID-19 immunisation. Medical history included cirrhosis unknown origin, autoimmune disease/unknown origin and no known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT), omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included 1st of BNT162B2 on 26Jan2021. The patient experienced sore arm day of injection (dose 2) on 16Feb2021, abdominal cramping/diarrhea post dose day 2 (17Feb2021) vax 2. No treatment was received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the lot/batch number has been requested.
72 2021-03-02 pain in extremity while she was on the top step of a 2-step stool, her left leg went out from her, and she fell straig... Read more
while she was on the top step of a 2-step stool, her left leg went out from her, and she fell straight back, landing on the floor; her left knee keeps wanting to go out/ left leg kept wanting to buckle under her; she has 2 big bruises on arm, 1 bruise at her elbow and 1 bruise on her upper arm.; horrible pain in her left back/ pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek; pain ran from the bottom of her left rib cage; caller experienced pain from her kidney to her butt cheek; her arm was mildly sore; her left leg muscle is sore from above her left knee; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 22Jan2021 10:00AM at a single dose on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included COVID-19 in Nov2020 and lost taste and smell. Reported she tested positive for the COVID-19 Virus in Nov2020. She said she was never sick during the time she had the COVID-19 Virus, though she lost her sense of taste and smell. She said she may have had a headache during that time, but she doesn't know if the headache was from the COVID-19 Virus or something else. She said anything she was experiencing during the time she had the COVID-19 Virus was kind of normal for her. Concomitant medications were none. Reported she got her first dose of the COVID-19 Vaccine on Friday, 22Jan2021, and thinks she may be having an adverse reaction. She said after she received her COVID-19 Vaccine, she was OK for the remainder of Friday, 22Jan2021, as well as, Saturday morning, 23Jan2021. Reported she was working outside the day before she had her first COVID-19 Vaccine dose (21Jan2021). She clarified she had a tree cut down in her yard, and she moved all the 3 foot length cut-up pieces of tree by herself. She had been moving tree cuttings. Her arm was mildly sore. Reported on Saturday (23Jan2021) in the middle of supper, she experienced a horrible pain in her left back. She clarified that the pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek. She said the pain was so bad she didn't think she was going to be able to finish eating supper. She said after supper she got on a heating pad and walked around the kitchen to see if that would help with the pain. She said she sat on the heating pad and walked around the kitchen 4 times that night. She said by Sunday (24Jan2021), the pain started to go away, and by Sunday night, she was OK. Reported this past Thursday, 28Jan2021, she was going to her mailbox. She said while she was walking out to her mailbox, she was holding onto her front porch post to go down the front porch stairs, and her left leg collapsed out from under her. She said she would have fallen if she wasn't holding on to the front porch post. She said she tried to continuing walking to the mailbox, and her left knee went out from under her again. She said her left leg kept wanting to buckle under her. She said after she got back inside her house, she sat down in a chair to read a book. She said she was making soup at the time and grabbed her husband's cane to walk to the kitchen. She said she is short and got on her 2-step stool to look in the freezer for vegetables. She said while she was on the top step of the stool, her left knee buckled and her left leg went out from under her. She said she fell straight back, landing on the floor. She said she has 2 big bruises on arm, 1 bruise at her elbow and 1 bruise on her upper arm. She said her left leg went out from under her again, yesterday (31Jan2021), while she was going to church. She said everything she has experienced since getting her COVID-19 Vaccine shot is only happening on her left side. Reported her left knee keeps wanting to go out and she has to be really careful when she walks. She said her left knee feels like it is wanting to buckle, like when someone runs up behind you and hits the backside of your knee. She said her left leg muscle is sore from above her left knee. She said she doesn't know if what she is experiencing is from getting her first COVID-19 Vaccine dose, and she wanted to know if anyone else has reported a similar experience since receiving the COVID-19 Vaccine. For fall treatment, she took a couple of Aleve 220mg tablets (UPC Number: 325866555090, Lot Number: NAA6W3T, Expiration Date: Jun2021) on 28Jan2021, after she fell off her stool. Reported she took another 2 Aleve 200mg tablets last night (31Jan2021) at 11:00PM. Reported she is pretty darn healthy and only takes 3 pills. No other details provided. Reported she is trying to lock her left knee when she walks, saying she can feel her left knee giving away. She said she while she was walking down a small ramp at church on Sunday (31Jan2021) her left knee wanted to buckle from under her. She said she had to hold onto a railing while she was walking down the ramp, so she wouldn't fall. She said she is not used to her left knee trying to go out from under her. The reported adverse events did not require a visit to the emergency room or physician office. Outcome of events "horrible pain in her left back/ pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek" (back pain, rib pain, and buttocks pain) was recovered on 24Jan2021. Outcome of "her left knee keeps wanting to go out/ left knee kept wanting to buckle under her" (joint instability), and "her left leg muscle is sore from above her left knee" (myalgia) was not recovered. Outcome of the remaining events was unknown.
72 2021-03-03 weakness 2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, ... Read more
2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, with fever & brain fog, & felt very weak, & I had a swollen & sore lymph node under my arm. On day 6 my upper are (& underneath) turned red & swollen. I also had been suffering random itching. On day 8 I went ER, & was given steroid cream. That night most of my back turned red. I put the cream on & it was gone next day, but my arm stayed red & itching. All this has made me weaker, & My stomach hasn?t felt good.
72 2021-03-03 pain in extremity Chills,fever,almost passed out,headache,sore arm
72 2021-03-03 pain in extremity Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report... Read more
Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the left arm on 25Jan2021 (13:45) at a single dose for COVID-19 immunization at the university clinic (not a military facility). Medical history allergy to penicillin; allergy to bees; allergy to environmental grass and ragweed; and was in muscle relaxant therapy. Concomitant medications included cannabidiol (CBD OIL) as muscle relaxer; and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). The patient previously took SHINGRIX on 18Oct2019 (when the patient was 71 years old) for shingles vaccine, and had subacute thyroiditis, enlarged thyroid and glands, rash from wrist to arm and shoulder, swollen and sore arm, and swollen neck glands and thyroid around left side. The patient previously took codeine, and had allergy. On 25Jan2021 (20:00), the patient had sore arm. The sore arm improved the next day. On 30Jan2021 (between 18:00 and 19:00), the patient was "sort of" feeling achy. On 30Jan2021 (23:00), the patient had fever of 100.4 (unit was not provided). The patient took paracetamol (TYLENOL) as treatment for the fever, and started getting better. The patient got tested as a precaution, and was negative for COVID-19 test on 31Jan2021. On 31Jan2021 (between 08:00 and 09:00), the patient had stomach issues. On 31Jan2021 (13:00), the patient had chills. The outcome of the events, 'sore arm', 'achy', 'fever', 'stomach issues' and 'chills', was recovering. The patient was due to the second dose of vaccination on 15Feb2021, and wanted to know if it would be okay for her to get it.
72 2021-03-03 pain in extremity Left big toe swollen/painful and foot and toes were red
72 2021-03-03 numbness Numbness and slight swelling on entire left side of face within half hour following shot, accompanie... Read more
Numbness and slight swelling on entire left side of face within half hour following shot, accompanied by severe stiff neck (left side). Headache and slight transient facial rash with skin discoloration under eyes about two hours later. Mostly subsided by 10:30 PM- about eight hours later, although some numbness remained l through the night. Symptoms were mostly gone the next morning, replaced by arm soreness and bruising at the injection site. Black and blue remains (3 days later).
72 2021-03-03 hot flush left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear wh... Read more
left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear where you cannot scratch; severe tightness in her left eye that felt like it was going to swell up; hot skin for several hours; hot flashes; She has itching in ears and throat; Onset of burning and itching; Skin had feeling of about to break out in hives/full blown body hives all over; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3249), intramuscular on the right arm, at the age of 72 years, on 13Jan2021 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient would like to know if the vaccine was derived from or does it have any products from Acacia. One of the reason's she was asking was because she knows it has Polyethylene Glycol in it. Her resources are limited. She was a retired healthcare provider and she taught graduate level nursing and has background in epidemiology and public health. The Polyethylene Glycol was in the vaccine, according to the prescribing information. Some forms of Polyethylene Glycol in some type of way are derived from gum acacia and she does not know if this is the case for the COVID vaccine. She did have 1st dose and waited 15 minutes. When her left eye felt tight and felt itchy, she took 2 Benadryl and then waited in car a little longer. She felt like she was going to go into what she has had in past 3-4 times relating to fish. She has had full blown facial swelling, intense itching in inner ear where you cannot scratch. Those times, if she had chopsticks, she would want to scratch inside her ear. She never had that with the COVID vaccine. They told her when she got the vaccine that if this develops further, she should go to her doctor or ER, but should not come back there. She did not want to go to the ER and sit there for 12 hours waiting to see if she was going to have a worse reaction, so she went home, took 2 more Benadryl, and went to bed. Eight hours later, she was fine and did not have hives. She then stated she completed report with Pfizer online and did not have a reference number for previous report. For those time when she had these episodes with the fish, she had extreme itching and hives. The worst allergy she had, her fingers looked like they were webbed. She was treated with Adrenaline, Cortisone and Benadryl by injection and that would usually stop the reaction, but it usually takes 3-4 days for the swelling to go down. In later years, if there is a piece of fish mixed in with fried shrimp and she inadvertently eats it, she knows it immediately. She will take Benadryl immediately. She will have facial swelling and swelling around her eyes. The Benadryl will contain it. She will be disfigured for 2 weeks, with bags of fluid in her cheeks. She is going for her second shot tomorrow. She can self treat with Benadryl. In 1994, she had a very positive wheels from an intradermal scratch testing for Acacia and codfish. The patient had an onset of burning and itching, periorbital. She took 2 25 mg Benadryl tablets. She has itching in ears and throat. After my 15 minutes waiting, she left. She had various hot spots of burning skin, legs and arms. Left eye felt like past episodes of itching, about to swell. Her skin had feeling of about to break out in hives. Facility said to go to provider or ER if got worse. She chose not to go to ER, and wait and be miserable for hours on end, while waiting for full blown body hives all over. She took two more 25 mg Benadryl and went to bed. She had intermittent burning skin, various areas, for several hours. About 8 hours later, was resolved. The patient was about to receive 2nd dose of the Covid vaccine. After the 1st dose she experienced an itchy feeling in throat, rotating heat in arms and legs, slight bag fluid under left eye and it felt to her like she was going to have an allergic reaction but did not. She took some Benadryl and after 8 hours she was fine. The patient stated after the first dose of the vaccine she had itching, severe tightness in her left eye that felt like it was going to swell up, and hot skin for several hours. She took two Benadryl while she was still in the waiting period and perhaps that blunted the reaction. She had hot flashes on the drive home. She took two more Benadryl at her daughter house (100mg total after taking 4 that day). She didn't feel good and felt she was on the verge of getting hives. She had episodes of hot skin and itching and after 8 hours it was over and done with and she was fine. She stated she is nervous about the second dose but stated they have what they need if she has an immediate reaction and it is worth the risk of getting vaccinated. Therapeutic measures were taken as a result of left eye felt tight and felt itchy/severe tightness in her left eye (eye pruritus), intense itching in inner ear where you cannot scratch (ear pruritus), onset of burning and itching (skin burning sensation), skin had feeling of about to break out in hives/full blown body hives all over (urticaria). The outcome of the event onset of burning and itching and skin had feeling of about to break out in hives/full blown body hives all over was recovered on an unspecified date while other events were unknown.
72 2021-03-03 feeling cold, muscle spasms, pain in extremity second dose soreness in left arm, Nightime pain in right arm; cold not full chills but cold; shoulde... Read more
second dose soreness in left arm, Nightime pain in right arm; cold not full chills but cold; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; This is a spontaneous report from a contactable 72-year-old female consumer reported for herself that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3247) single dose on 16Feb2021 09:00 AM at left arm for COVID-19 immunization. Medical history was not provided. Historical vaccine included 1st dose of BNT162B2 (EL3247) on 25Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Concomitant drugs included lisinopril, levothyroxine sodium (LEVOTHYROXIN), pravastatin, vitamin D and vitamin K. The patient reported second dose soreness in left arm, cold not full chills but cold, Nightime pain in right arm, shoulder neck down to wrist very sharp pains like muscle cramps started on 17Feb2021 at 01:00 AM. No treatment was received for the events. Event outcome was recovered.
72 2021-03-04 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable Physician and a consumer. A 72-years-o... Read more
Bell's Palsy; This is a spontaneous report from a contactable Physician and a consumer. A 72-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Left arm on 05Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. Concomitant medication included ASA, levothyroxine sodium (SYNTHYROID), telmisartan and simvastatin (ZOCOR). There was no other vaccine in four weeks. The patient previously took lisinopril and experienced allergy. The patient experienced bell's palsy on 20Feb2021 and treated with prednisone. Event resulted in Doctor or other healthcare professional office/clinic visit. Covid did not test post vaccination. The outcome was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered the reported serious event as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
72 2021-03-04 cold extremities, tremor Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until ... Read more
Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a bit feverish but getting better. A more severe reaction than from first shot on 2/8/2021 with similar side effects that lasted about 3 days. Fatigue did not go away.
72 2021-03-04 cold extremities, tremor Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until ... Read more
Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a little better.
72 2021-03-04 weakness, flushing Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and... Read more
Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and then blacked out woke up laying on floor, couldn't move arms or legs, not sure if hit head, laid on floor close to 1 hour, difficulty getting back into bed, extreme nausea, dry heaves, weak, headache, dizzy, chills, dizzy x 1 week, dizzy 3/3/21, got into bed 6:30 PM, face flushed and reddened, called daughter who is nurse, daughter checked temperature and blood pressure, no fever, B/P 156/102 (normally 120/82), B/P came down to when retaken to 140/90), was "upset" at time of first B/P reading, causing elevation. Continues to have weakness and fatigue, headache comes and goes.
72 2021-03-04 weakness Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hou... Read more
Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hours. After 4 hours weak for several hours.
72 2021-03-07 pain in extremity Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; C... Read more
Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Questioned if she might have a blood clot in left leg; Might have an infection in area of cellulitis in left leg; pain in the left leg; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, expiration date 31May2021), via an unspecified route of administration on 01Feb2021 at left upper arm around 19:00 or a little later at single dose (at the age of 72-years-old) for covid-19 immunization. Medical history included bad knees and got injections for this and recurrent cellulitis of legs (cellulitis was not active at time of vaccine; but anytime her leg swells with bad knees she had a little episode with the cellulitis down around her ankles on both legs but left leg was more predominant. She had been keeping it at bay), mineral supplementation, bad knee pain, blood pressure medication (abnormal), urine output control (abnormal), dehydrated and dizzy. Concomitant medication included lisinopril as blood pressure medication, potassium for Mineral supplement, solifenacin succinate for urine output control, paracetamol (TYLENOL 4) for bad knee pain. She had taken potassium before and it calmed it down: she was little dehydrated, little dizzy, so was drinking some Pedialyte, water, and taking potassium. The patient had it once before but it kind of snuck up on her again. The patient called to ask if anyone had reported any type of blood clot on the same side of the body that the Pfizer COVID-19 Vaccine was administered. She questioned if she might have a blood clot in her left leg after having been administered the Pfizer COVID-19 Vaccine. She had recurrent cellulitis in both legs prior to Pfizer COVID-19 Vaccine. The doctor thought the cellulitis in left leg may be acting up and that she might have an infection in that area of cellulitis. She reported pain in the left leg when she rested her leg on a pillow; but did not feel any pain when she was standing and walking. The pain became a little too hard for her to bear so the doctor prescribed her Cephalexin 500m capsule every 12 hours-she was on the 3rd capsule now. Onset date for the events was approximately 03Feb2021 or 04Feb2021. The events were better since started Cephalexin. Second dose date scheduled for 22Feb2021 but did not give her time. The outcome of the events was recovering. Follow-up (23Feb2021): New information received from the product quality complaint group includes confirmation of lot number (EL9262) and new expiry date.
72 2021-03-07 weakness Patient is a 72-year-old female presenting with fever and altered mental status. History is obtaine... Read more
Patient is a 72-year-old female presenting with fever and altered mental status. History is obtained for the patient and her husband. She got her second dose of Pfizer vaccine for Covid on 3/6/21. On 3/7/21, she woke with fever and urinary symptoms. She have an episode of incontinence and urinary frequency and urgency today. She was too weak to get up out of the recliner at home. She did have a fever this morning, which resolved with Tylenol. She also has been confused much lower mentally than normal. She is on 4L chronically for COPD, DM, HTN, HLP, CAD, previous DVT. She has had sepsis previously. She was admitted to the hospital, and received one dose of IV Rocephin, IV fluids, and tylenol.
72 2021-03-10 bell's palsy, unresponsive to stimuli, facial pain Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; no... Read more
Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; non-amblitory, could not support weight, major balance issues. Televisit 1/26/21=earache. Blacked out cold 5 min, non responsice 30 min 2 am 1/26/21; woke with Bell's Palsey; Ddumb televisit 1/28/21=BP. Urgent Care visit-EKG (normal), bloodwork, urine lab work. 2/1/21 Saw NEURO = MRI brain w/contrast to rule out cancer (2/4/21; Two weeks of solid hallucinations 24/7. Horrendous balance issues-almost non-amblitory from onset 1/26/21 to present. Lost 9 pounds in 2 weeks.(I was 104 now 95 pounds). I was walking 5 mi a day, walked 1/24/21, healthy. Devastating pain to left side of head/face, esp ear. PAIN
72 2021-03-14 speech disorder, weakness, pain in extremity, tingling, tremor severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hur... Read more
severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hurt 48 hours; severe whole body muscle pain even my fingers hurt 48 hours; drooling woke me up soaked the pillows; headache worse in my life 48 hours; dropping things hands wouldn't work; vomiting; severe diarrhea still problematic; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Still can't function normally 5 days now after 2nd shot; Still stuck in the house to weak to leave; Cognitive dysfunction; could not drive; trouble speaking; pins and needles both arms and legs; ataxia; received second dose of bnt162b2 on 19Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 72-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 19Feb2021 01:15 pm on left arm at single dose for covid-19 immunisation. Medical history included Known allergies: iodine dye X-rays from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took first dose of bnt162b2 (COVID 19, brand: Pfizer) on 22Jan2021 at arm at single dose for covid-19 immunization. The patient experienced cognitive dysfunction (cognitive disorder) (medically significant) on 19Feb2021 18:00 with outcome of not recovered, could not drive on 19Feb2021 18:00 with outcome of not recovered, trouble speaking on 19Feb2021 18:00 with outcome of not recovered, pins and needles both arms and legs on 19Feb2021 18:00 with outcome of not recovered, ataxia on 19Feb2021 18:00 with outcome of not recovered, severe brain fog still 5 days later dysfunctional on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, drooling woke me up soaked the pillows on an unspecified date with outcome of not recovered, headache worse in my life 48 hours on an unspecified date with outcome of not recovered, dropping things hands wouldn't work on an unspecified date with outcome of not recovered, vomiting on an unspecified date with outcome of not recovered, severe diarrhea still problematic on an unspecified date with outcome of not recovered, chills/cold shaking so hard teeth chattered on an unspecified date with outcome of not recovered, still can't function normally 5 days now after 2nd shot on an unspecified date with outcome of not recovered , still stuck in the house to weak to leave on an unspecified date with outcome of not recovered. No treatment received. She is not pregnant. Facility type vaccine was hospital. No other vaccine in four weeks. The patient reported that "Cognitive dysfunction, could not drive, trouble speaking, pins and needles both arms and legs, ataxia, stumbling. 72 hours of ataxia severe Brain fog still 5 days later dysfunctional severe whole body muscle pain even my fingers hurt 48 hours drooling woke me up soaked the pillows , headache worse in my life 48 hours dropping things hands wouldn't work vomiting and severe diarrhea still problematic Chills/cold shaking so hard teeth chattered Still can't function normally 5 days now after 2nd shot Still stuck in the house to weak to leave , still ataxic." No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch number is requested.
72 2021-03-15 tingling, tenderness, numbness I am reporting the below as everything written has NEVER happened to me before in my 72 years of liv... Read more
I am reporting the below as everything written has NEVER happened to me before in my 72 years of living. This has all taken place since I have had the Vaccine Injection on Wednesday, February 24th. I am attributing all of this as a possible reaction to the vaccine or maybe coincidence. I wanted to report what has taken place so you all can assess if this is a possible adverse reaction, a direct effect from the vaccine or just coincidence. Please let me know if anything like this has been reported and what your thoughts about the matter. Wednesday, February 24th 11:15am Pfizer Vaccine right arm ?about an hour later discomfort on shot side that went from the shoulder up the right side of the neck. Was gone by next day. Thursday, February 25th Day seemed to be normal. When I went to bed that evening a pressure and pounding on the left top side of the head, on the part line. Lasted 5-6 hours and then went away for that episode. Friday, February 26th Day started off OK, walked 2 miles and then ran some errands. *3:00pm I bent down to pick up something and when I came up I had extreme light headedness like I have never had before. I was able to get myself collected and then continued to get ready to go out. *6:00pm I just sat in a chair in the restaurant and BAM the room started spinning at about 500 miles (that is the speed that it felt like) an hour. My arms were flailing as I was trying to grab something to old onto. Just when I was about to fall off of the chair my husband walked up and grabbed me as he could see that something was going on and he said that I was white as a sheet. Once I got somewhat collected, I knew immediately that I had to throw up. My husband took me to the restroom. I had severe dry heaves that just would not stop. I wasn?t breathing properly so my hands and feet were numb, tingly and very white in color. Then I had to have a bowel movement. We phoned for the ambulance to take me to the hospital jus to make sure that I did not have a stroke, or it was my heart, or a vessel had burst in the head. The Paramedic tested me for a stroke and I passed the test. *8:00pm or so I had another episode with room going around at top speed and I started having dry heaves. Nurse gave me medicine in the IV for nausea. My Doctor said that everything was Benign. He said that the CT patient scan was negative and all other tests were OK. Saturday, February 27th I was released from the hospital and went home. I did very little that day. I slept that night from 10:00pm until 10:00am the next day. Sunday, February 28th I was lightheaded, had a headache, and ears ringing all day. I just did not feel myself at all. Tuesday, March 9th Around noon I had a severe lightheadedness/spinning episode, eyes felt like they were spinning. Laid down for about 2 hours and when I got up I was able to function and the spinning had gotten better. Headache all night long, ears ringing, feeling of lightheadedness. Wednesday, March 10th Not quite as dizzy, headache all day, back of neck and left side of head sore to touch. Pounding on left top side of head ? along the part line, where I had the same discomfort the 2nd day after the vaccine. Thursday, March 11th Having discomfort on left side of head. To the right of the left ear, going down to the neck. I can touch those areas and add to the discomfort. Friday, March 12th On Monday, March 7th I noticed a red spot on the right side behind where I was given the injection. I tried to treat it myself but my remedies were not helping. Contacted my Dermatologist on Thursday, March 11th. She saw me today, Friday, March 12th. She is not sure if it is a possible aftermath of the vaccine or something else. Had some bloodwork run to rule how Shingles. Prescribed some medication for Shingles to take until Monday when the bloodwork report is due for review. Blood work was negative for Shingles. Ever since the episode on February 26th I have NOT felt myself at all. Lightheaded, nausea, headache, pressure in head and feels heavy, not steady on my feet, discomfort in back of head near neckline, on/off discomfort in the top of the head with a pounding force. BLOOD PRESSURE IS NOW HIGHER THAN NORMAL ESPECIALLY WITH BOTTOM NUMBER BEING HIGH. I have never had a Blood Pressure problem, although as I have aged the top number has elevated but not enough to take medicine. However, the lower number is now elevated (high 80-?s, low mid range 90?s) and Cardiologist is going to make a decision on whether I should start on a low dose medicine. I am to take my 2nd Pfizer shot tomorrow ? Wednesday, March 17th at 11:00am. Thank You for reviewing the above writings. I look forward to the conclusion VAERS makes on my situation.
72 2021-03-15 facial paralysis Patient reported have a slight left sided mouth droop on 3/8/2021- went to ER states EKG, CXR, and C... Read more
Patient reported have a slight left sided mouth droop on 3/8/2021- went to ER states EKG, CXR, and CT of head all negative. Kept overnight and had MRI 3/9/2021 in AM revealed "mini stroke" TIA per neurology. She was discharged with Plavix and Lipitor. Has follow up appointment with neurologist 4/8/2021 and cardiologist 4/1/2021. Patient states she was on Amiodarone and Bystolic prior to having this TIA. Patient is scheduled for second dose of vaccine 3/19/2021 and wants to receive it. She is cleared to receive from our stand point. Please reach out via email or phone if you guys disagree.
72 2021-03-18 weakness RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tastel... Read more
RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tasteless/no taste; fibro; no taste/food was tasteless; She did not feel very well; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for her husband and herself. This is the first of two reports for herself. Only this case is serious. A 72-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot # EN6201, via an unspecified route of administration on 10Feb2021 17:15 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified products in two weeks. There was no other vaccine in four weeks.The patient experienced coughing, weak, no taste, chilling, diarrhea, no energy, headache all on 11Feb2021. She did not feel very well on the day she took her shot on 10Feb2021 but did not have a fever. She was not hungry but food was tasteless.It was also reported that "she had RA OA and fibro. and take thyroid medicine besides medicine for the others. Adverse event start date: 11Feb2021". No treatment was received for all events and events outcome was not resolved.The patient did not have COVID prior vaccination and no COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207100 same reporter/product, similar events, different patient
72 2021-03-22 discomfort, numbness, burning sensation Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose star... Read more
Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose started and continues until now. It decreased after dermatologist perscribed medication. On 3/13 went to hospital with severe chest pain. They determined it was muscular-sceletal. While in the hospital and to this day has burning in bottoms of feet. Has weakness and numbness in both legs and feet. The weakness decreases ability for activity- very uncomforatable and making her unsteady when up. She also has some weakness in her arms.
72 2021-03-23 flushing my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started ... Read more
my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started feeling stuffy; felt flushed; my face was red; what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain; what feels like my heart quivering for several seconds; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at left arm on 08Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included gastroesophageal reflux disease, osteoarthritis, nodules on thyroids and allergy to Aspartsme. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40). the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took Sulfanomide (Sulfa drugs) and had allergy (swelling), codeine and had allergy (nausea). The symptom that has made patient concerned enough to report the possibility of a side effect is: she had her shot this morning and between about 8:55 and 9:15 this evening she had 9 or 10 episodes of what feels like her heart quivering for several seconds followed 3 or 4 times by very slight pain, just below her right breast, she has never experienced such a thing before. (she took baby aspirin around 9:20 in case she was having some kind of heart thing). It's 9:45 pm, and the quivering episodes haven't happened for the last 30 minutes, so maybe they're all cleared up. Earlier, within 30 min of getting the vaccine, her ears started feeling like they were stopped up and her nose started feeling stuffy. Then as she was driving home she felt flushed and looked in the mirror and her face was red, she took one Sudafed in case it was allergies, and those symptoms improved quite a lot. Adverse event start date was 08Mar2021 10:00 AM. Since the vaccination, the patient has not been tested for COVID-19. Unknown if treatment received for ears started feeling like they were stopped up and nose started feeling stuffy. Outcome of what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain was recovered. Outcome of felt flushed and face was red was recovering and outcome of other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
72 2021-03-24 inability to speak, one side paralysis Aphasia & right sided weakness. CVA.
72 2021-03-24 migraine two migraine headaches - atrial fibrillation; two migraine headaches - atrial fibrillation; This is ... Read more
two migraine headaches - atrial fibrillation; two migraine headaches - atrial fibrillation; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration in the left arm on 07Mar2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included warfarin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); both taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 10:00, the patient experienced two migraine headaches and atrial fibrillation. It was unknown if the patient received any treatment for the events. The clinical outcomes of the two migraine headaches and atrial fibrillation were recovered in Mar2021.
72 2021-03-27 bell's palsy Bell's Palsy - right side of face is paralyzed, right eye doesn't close fully, teary right eye, blur... Read more
Bell's Palsy - right side of face is paralyzed, right eye doesn't close fully, teary right eye, blurry right eye, and headache; This is a spontaneous report from a contactable healthcare professional (patient). A 72-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in right arm on 05Mar2021 10:00 as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hypothyroid, chronic achilles tendonitis, pre-diabetic. The patient had no known allergies. Concomitant medications included losartan, metoprolol; thyroid (NATURE THROID) reported as 'Zinc Berberine Nature Throid.' The patient was not diagnosed with COVID prior to vaccination. She was not pregnant. No other vaccine was administered in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) via unspecified route in right arm on an unspecified date at 12:00PM. On 06Mar2021 12:00PM, the patient experienced Bell's palsy - right side of face was paralyzed, right eye doesn't close fully, teary right eye, blurry right eye, and headache. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received included CT scan of brain, prednisone 60 mg total, and valaciclovir (VALTREX) 1. Outcome of the events was not recovered. The patient had not been covid tested post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
72 2021-03-29 numbness, tremor, seizure, cold extremities mini stroke or seizure; mini stroke or seizure; pinched nerve; left arm was weak, numb, cold; left a... Read more
mini stroke or seizure; mini stroke or seizure; pinched nerve; left arm was weak, numb, cold; left arm was weak, numb, cold; left arm was weak, numb, cold; a fine tremor on extension of my arm; This is a spontaneous report from a contactable other hcp (nurse and patient). A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:45 (Batch/Lot Number: EN6198) as SINGLE DOSE (at the age of 72 years) for covid-19 immunisation. Medical history included partial seizures, autoimmune thyroiditis, eczema, osteoarthritis, asthma, irritable bowel syndrome, carpal tunnel syndrome from an unknown date and unknown if ongoing 10 years ago. The patient is not pregnant, and the patient did not have Covid prior vaccination. Concomitant medication included phenytoin (DILANTIN) taken for seizure, start and stop date were not reported; levothyroxine sodium (SYNTHROID); ergocalciferol (VIT D) and unspecified vitamin. The patient previously took amoxicillin and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity, azithromycin and experienced drug hypersensitivity. The patient experienced mini stroke or seizure on an unspecified date with outcome of unknown, left arm was weak, numb, cold and a fine tremor on extension of arm on 03Mar2021 14:45 with outcome of recovered. On 06Mar2021, patient woke up and left arm was weak, numb, cold and she had a fine tremor on extension of arm. Symptoms resolved after 45 minutes but returned within 30 minutes and lasted another 45 minutes. No treatment was received for left arm was weak, numb, cold and she had a fine tremor on extension of arm. Patient called doctor, spoke to the advice nurse and was advised to go to the ER (emergency room) now. Patient did deep breathing and relaxation, symptoms resolved, and did not go to the ER. Instead spoke with a doctor and agreed to go to the ER if symptoms returned. Patient also had a video visit with primary doctor, and she was advised to take baby ASA. The Doctor said it could be a pinched nerve on unspecified date with outcome of unknown. Symptoms have not returned. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Mar2021. The case was reported as non-serious.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the CVA and other events. The reported events likely represent intercurrent medical conditions. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, EEG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
72 2021-03-30 difficulty speaking, facial pain had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylacti... Read more
had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; pain in abdomen and face/Abdominal pain; pain in abdomen and face; Generalized pruritus with skin rash; Respiratory distress; Angioedema (not hereditary); a lot of pain after her tooth extraction; Upper airway swelling; Cyanosis; Hoarse voice; Difficulty breathing; Sensation of throat closure; Generalized urticaria (hives); Generalized erythema; Generalized pruritus with skin rash; Localized injection site urticaria; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6199) (at the age of 72 years old) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD); osteoarthritis; rheumatoid arthritis (RA); allergy: Environmental; asthma. Concomitant medications included ubidecarenone (COQ10 [UBIDECARENONE]) ongoing; atorvastatin ongoing; nebivolol hydrochloride (BYSTOLIC) ongoing; methimazole ongoing. The patient was taking some medications prior to the event being reported. No prior vaccinations (within 4 weeks). The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than bnt162b2 prior to the event being reported. The patient had not received any other vaccines around the time of bnt162b2 vaccination. Caller would like to know if there was an impact on efficacy if she chooses to take her second dose of the Pfizer BioNTech COVID-19 vaccine at a later date than the recommended 21 days. Caller received her first dose of the Pfizer BioNTech COVID-19 vaccine on 03Mar2021. She stated that on 08Mar2021 she had a tooth extraction and was told by her physician to take Advil. Then on 11Mar2021 caller reported that she had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days. She stated that her physicians were unsure if it could have been a delayed reaction to the vaccine or a reaction to the Advil (which caller stated she had taken all her life) (lot number: 55633, Expiry Date: Feb2023). Caller was scheduled to receive her second dose of the vaccine next week and would like to know if she should take it. She stated one physician told her it was okay to do so while another told her to hold on taking it, so she was confused as to what to do. Reporter seriousness for Anaphylactic reaction was Hospitalization. The patient was in hospital for Anaphylactic reaction from 11Mar2021 to 14Mar2021. The patient stated she received her first COVID vaccine on 03Mar2021, and on 08Mar2021, she had a tooth extracted. Because of that, she was taking Advil on 11Mar2021, she had an anaphylactic reaction to the Advil and an acute hepatitis. And the doctors couldn't give her any answer. They didn't know what caused what and if it was a delayed reaction from the vaccine because it was one week following the vaccine or if it was just coincidental. The patient due next week (scheduled for 23Mar2021) for her second dose and wanted to know if she should she take it. She ended up in the hospital for five days. Date of hospitalization was 11Mar2021. Reason for hospitalization was Anaphylactic reaction. Date of discharge from the hospital was 14Mar2021 (pending clarification). Event "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days" started from 11Mar2021 18:00. Seriousness Criteria: Hospitalization / Prolongation of hospital, hospitalized Duration of stay was 5d, event not recovered. The event required visit to Emergency Room. Treatment included steroids and fluids IV. "Tooth extraction" started from 08Mar2021 and treatment included Tylenol and Advil. Consumer stated she was still in a lot of pain after her tooth extraction (Mar2021). On 08Mar2021 she had a tooth extraction. After the procedure she had severe pain and she was taking Advil and by Thursday 11Mar2021 she had a lot of pain in abdomen and face. She went to ER 18:00 PM, she was going through a complete reaction. The patient required medical intervention: Corticosteroids, IV fluids. The patient was seen in the Emergency Department. The patient had hospitalized for 5 days. The patient was not admitted to an Intensive Care Unit. In Mar2021, the patient had Upper airway swelling, Respiratory distress, Cyanosis, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Generalized urticaria (hives), Generalized erythema, Angioedema (not hereditary), Generalized pruritus with skin rash, Localized injection site urticaria, Abdominal pain. No Bilateral wheeze/bronchospasm. No Stridor, No Increased use of accessory respiratory muscles, No Recession, no Grunting, no Dry cough, no Sneezing, No Rhinorrhea, No Shock, No Tachycardia, No Capillary refill time > 3 sec, No Decreased level of consciousness, No Loss of consciousness, No Generalized pruritus without skin rash, no Generalized prickle sensation, No Diarrhea, no Nausea, no Vomiting. Tachypnoea: Unknown. Measured hypotension: Unknown. Reduced central pulse volume: Unknown. The events did not require the initiation of new medication or other treatment or procedure. Lab work included Liver function over 10 000 in Mar2021. Patient's outcome following the potential anaphylactic reaction was Recovering. The outcome of the events "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days", "a lot of pain after her tooth extraction" was not recovered, of "pain in abdomen and face" was unknown, of the other events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events anaphylactic reaction, hepatitis acute, and respiratory distress with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
72 2021-04-01 cold extremities Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hos... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hospital for her first covid vaccine. After approximately 10 minutes vaccination, she started feeling dizzy, light headed, slightly nauseated. Reports sweating and cold hand. Patient was taken to the emergency department and later admitted to the hospital with new onset afib/aflut with RVR following first dose of Pifzer Covid-19 vaccination. Further workup revealed reduced EF on ECHO and elevated LFTs. Patient was treated and discharged home.
72 2021-04-04 inability to speak Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion,... Read more
Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion, inability to speak or find correct words for communication, sitting up on her own, incontinent episode x1, admitted to hospital for fever, vaccine reaction, discharged home
72 2021-04-06 facial paralysis 1st symptom 3/19/21 at 5:30 am - Weakness in fingers on right hand. Called nurse line, they recommen... Read more
1st symptom 3/19/21 at 5:30 am - Weakness in fingers on right hand. Called nurse line, they recommended calling EMT. EMT said no stroke but could go to urgent care for further evaluation. Urgent care recomended ER. ER recommended appointment with Neurology 2nd symptom 3/21/21 slight droop on right side of mouth. Went to ER in Hospital. MRI revealed clot. Additional ultra sound of heart and carotid arteries clear. Final diagnosis: Subacute CVA-Lt Centrum Semiovale w/ right facial droop and right hand deficits. Recomendations: Nuerology evaluation, Outpatient PT/OT for right hamd deficits. Hospitilization: 1 day Hospital Name: Unnamed City: Unnamed State: Unnamed
72 2021-04-11 weakness Pt received first dose of the Pfizer COVID 19 vaccine on 3/30/2021. She presented to the ED on 4/1... Read more
Pt received first dose of the Pfizer COVID 19 vaccine on 3/30/2021. She presented to the ED on 4/11/2021 with fatigue, cough, hypokalemia, and generalized weakness. She was admitted to an inpatient unit and tested for COVID-19 which came back positive. Anticipated discharge is today, 4/12/2021
72 2021-04-17 pain in extremity congestion in her chest; The congestion in her chest is, she knows it's there, it's tight,; cough; a... Read more
congestion in her chest; The congestion in her chest is, she knows it's there, it's tight,; cough; arm was sore; This is a spontaneous report from a contactable consumer (patient) reporting for herself. This is report 1 of 2. A 72-year-old consumer (female) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266, Expiry date: May2021) via an unspecified route of administration on 25-FEB-2021 at left arm around 11:30 -12:30 and patient received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8730/GR8730) via an unspecified route of administration on 25Mar2021 both as a single dose for COVID-19 immunization. Medical history and concomitant medication reported as diabetes and blood pressure medicine (From: Unspecified To: Ongoing), has since about 2015 or 2013 or something like that. She declines to provide her medication. She is not a serious diabetic. Sometimes she does not have to even take the diabetes medication because she keeps her A1C is so low she doesn't have to take the diabetes shots. She did not receive any other vaccines within four weeks prior to the vaccination. She didn't have any other real problems with the first dose of Pfizer COVID-19 Vaccine other than her arm getting sore. For her second Pfizer COVID-19 Vaccine she don't have to bother her arm. She had a little cough started sometime last week before she took the second Pfizer COVID-19 Vaccine. The cough doesn't happen all the time. She was coughing quite regular every 2-3 minutes before. She got the Diabetic Tussin cough syrup which has no sugar or alcohol. After taking that cough started quieting down. She was asking is it a regular cough or did the Pfizer COVID-19 Vaccine cause the cough. She's taking it once a day sometimes twice a day. It is nasty cause it's got nothing in it. Maybe she is not taking it enough, it says to take it every 4 hours, maybe she is not taking it enough, she does not know. She is taking it maybe once or twice daily, maybe she takes it more. She reports it's not a constant cough. She also has some congestion in her chest. The congestion in her chest it's tight, she just knows it's there. Her chest congestion is staying about the same. If she gets rid of the cough, she'll get rid of the chest congestion she guesses. Caller reported that people are not educating themselves on these shots, referring to the Pfizer COVID-19 Vaccine shots. They'll tell you it's gone kill you; that she does not believe because some people have died, they took the shot and they didn't get a chance to take the second shot and they passed away. And they are telling her not to get the vaccine because it's going to hurt her. She's going to put it in God's hands and take that Pfizer COVID-19 Vaccine to help prevent or at least have it in her system. She's 72 years old and concerned about herself. The outcome of the event arm sore is unknown, little cough with outcome recovering, congestion in her chest outcome not recovered. Follow up (29Mar2021): This is a Follow-up spontaneous report received from a contactable consumer reporting patient information, event information, concomitant medication. Follow-up attempts are needed. Information on lot/batch number was obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021347466 Pfizer
72 2021-04-17 pain in extremity hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/cli... Read more
hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195; Drenched in sweat/sweating/sweating like a dog in the middle of the night; Wasn't feeling well; Tightness in chest; Cough; Sinuses congested; Sore; Puffy, bubbled up arms, inflamed; Puffy, bubbled up arms, inflamed; Feverish/felt hotter than usual; Really, really tired/wiped out tired; so sleepy; Sore Arm/her arm started to hurt; Nauseous; Sore Throat/throat hurts; eyes half closed/eyes closing; Puffy Face; blood clot; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733, expiry date: unknown), via an unspecified route of administration, on 29Mar2021 11:45, as single dose, for COVID-19 immunisation. Medical history included ongoing latex allergy (developed welts where the straps met the skin) diagnosed 20-30 years ago; ongoing dye allergy (developed warm soreness to leg, tightness in the chest, could not breathe) diagnosed many years ago; sulphite allergy (diagnosed about 1975-1980; cannot eat processed foods, bleached foods, frozen pre-made foods; tries to eat only single item foods; last anaphylactic reaction after eating olive oil at a restaurant because it had sulphites in it; Mother was possibly allergic to sulphites; Son also allergic to sulphites); and blood pressure that runs low. The patient previously took epinephrine and experienced epinephrine allergy; ciprofloxacin (CIPRO) and experienced Cipro Allergy (eyes closed, got puffy, couldn't breathe); amoxicillin for abscessed tooth and had a reaction because of the sulphites in it; epinephrine (EPIPEN) and experienced epinephrine allergy (does not use it anymore); plantago ovata (METAMUCIL) which she then found out the orange one had sulphites. Historical vaccine included flu shot for immunization and she experienced 104-degree temperature and was sick as a dog and she went to the emergency room (she had flu shot maybe 3 times). Ongoing concomitant medication included multivitamins. The patient got her first dose of BNT162B2 on 29Mar2021 at 11:45. On the same day, once she got home, she became really, really tired/wiped out tired; was so sleepy; experienced sore arm/her arm started to hurt; was nauseous; had sore throat/throat hurt; eyes half closed/eyes closing and puffy face. On 30Mar2021, the patient experienced elevated pulse/her pulse got too high/pulse was 165 beats per minute/climbed up to 195. Her heart rate was 194 at some point for a couple of minutes then stayed at 165 for a long time. She hoped she wasn't having a heart attack. She had tightness in her chest, wasn't feeling good and was coughing. She stayed in her bed to wait out her symptoms. These lasted for 10 minutes (as reported). She started meditating hoping her heart rate would decrease and it did after about 15-20 minutes. The patient also felt feverish/felt hotter than usual. Before she took the vaccine on 29Mar2021, her temperature was at 96. She stated that her temperature usually runs low as 95-06 degrees. She also felt like her sinuses were congested; was sore; had puffy, bubbled up arms, inflamed. The patient hoped it was not a blood clot she developed. At the time of the report, the patient stated that her heart rate was 61 beats per minute, earlier it was in the 70s; and her temperature was at 96.3. Her second dose is scheduled on 19Apr2021 and mentioned that if these were her reactions with the first dose, she is questioning getting the second dose. The outcome of "blood clot", "hoped she wasn't having a heart attack", "Wasn't feeling well", "Tightness in chest", cough, and sinuses congested was unknown. The patient recovered from "Drenched in sweat/sweating/sweating like a dog in the middle of the night", and "Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195" on 30Mar2021; and was recovering from "Sore Arm/her arm started to hurt", and "eyes half closed/eyes closing". The outcome of the remaining events was not recovered. Information on the lot/batch number has been obtained. Additional information is expected.
72 2021-04-20 feeling cold Dry heaves; diarrhea; headache; ringing in her ears; dizziness; fever; chills/ shaking with chills; ... Read more
Dry heaves; diarrhea; headache; ringing in her ears; dizziness; fever; chills/ shaking with chills; sweats; Freezing; dehydrated; This is a spontaneous report from a contactable consumer who reported for herself. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ER8732, via an unspecified route of administration, administered in left arm on 25Mar2021 at 16:30 as single dose for COVID-19 immunisation. Medical history included ongoing osteoarthritis. She had severe osteoarthritis and took medication for the arthritis pain. She said she had been taking the osteoarthritis pain medication for a couple years. Concomitant medications were not reported. Patient has no additional vaccines administered on same date of the Pfizer vaccine and has no prior vaccinations (within 4 weeks). Patient with a history of severe osteoarthritis said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 25Mar2021. The next day on 26Mar2021, she had terrible diarrhea, headache, ringing in her ears, dizziness, fever, chills and sweats. She was admitted to hospital from 29Mar2021 to 31Mar2021. Consumer wanted to know if she should still receive the 2nd dose. She further reported that she got her COVID-19 Vaccine late in the afternoon on 25Mar2021. She said she seemed fine after she got her COVID-19 Vaccine. She said the next morning on 26Mar2021, she woke up with terrible diarrhea, (really bad) headache, ringing in her ears, and dizzy. She said everything went sideways on 26Mar2021. She clarified she also had the chills, was soaking wet with sweat (but never seemed to have a fever). She said she was either sweating, freezing, or shaking with chills. She said she kept having diarrhea. She said on 29Mar2021 she had dry heaves with the diarrhea, and finally went to the Emergency Room. She said while she was at the hospital, she overhead hospital staff saying they thought she had the COVID-19 Virus. She said she treated as if she had the COVID-19 Virus by the hospital staff. She said she had a negative COVID-19 Virus nasal swab test, and the negative COVID-19 nasal swab test had come back within an hours-time on 29Mar2021. She said she was admitted to the hospital because she was dehydrated, and the doctor wanted to make sure she was over her diarrhea and getting better. The adverse events required a visit to the emergency room. She said she was hesitant about getting the second COVID-19 vaccine because of her severe side effects. She had blood work and a urinalysis done at the hospital in Mar2021. Diarrhea and dehydration treatment: Reported she took 3 doses of anti-diarrheal medication on 27Mar2021, and another dose on the morning of 29Mar2021 before she went to the Emergency Room. She said her diarrhea had kind of stopped after the morning of 29Mar2021, because she was unable to provide a stool sample when she went to the Emergency Room. Reported while she was admitted to the hospital, she was given IV fluids. She said she was unsure which IV fluids she was given. Patient reported she had recovered completely from all her reported symptoms in Mar2021.
72 2021-04-21 seizure 4 seizures over a 2 Week period involving hospitalization.
72 2021-04-24 pain in extremity Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racin... Read more
Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding; Arm barely sore; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 72-years-old , via an unspecified route of administration, administered in Arm Left on 31Mar2021 11:40 am as single dose for covid-19 immunisation. Medical history included ongoing food allergy, she had anaphylactic shock from a food allergy (she was 40 at the time and she doesn't eat anything she is allergic to), sinus infection and then got horrible hives under her eyes. No Prior Vaccinations (within 4 weeks). Concomitant medication was eye drops every night. No additional vaccines administered on same date of the Pfizer Suspect. The patient previously took epipen had two episodes when she was 40. She is bad about carrying her EpiPen, she forgets it. She was allergic to Amoxicillin. At 11:40 am last Wednesday patient had the vaccine, and around 4 or 5 pm, her heart started pounding for 10 seconds, and it felt like forever. An hour later, her heart started pounding again. It happened twice an hour apart and the second time lasted longer. It described as hard pounding. It started at 4 or 5 pm and then for 4.5 hours there was nothing, but then her heart started racing. At around 4 or 5 pm her heart was pounding, than around 9:30 pm her heart started racing and beating fast, she could feel it. She lives in a rural community and her husband called the local fire station and asked if he could take her there, to the station, so that she could have her heart checked. She was hooked up to a monitor and the paramedics said that she had an irregular arrhythmia and needed to go to the hospital by ambulance. Her heart rate was 115 to 130 beats, then 140 beats, at the hospital. It was about 11pm when she was evaluated and then left in the ambulance, as she was 45 minutes from the hospital. The paramedics would have, the arrhythmia, on record and that 5 minutes before she got to the hospital, the paramedic said her heart rhythm was normal. She was not admitted to the hospital, but held in observation and left the hospital at 4:30 in the morning. She hasn't felt anything after that. it was only one time she thought her heart was going faster, after that, but it didn't happen again. It is currently no problem and even at the hospital, the heart racing stopped and it was normal. The doctor in the emergency room said she was totally normal. Her arm was barely sore, when touched, and noticed this when she was being helped to the bathroom in the emergency room, maybe later in the afternoon, it was not hurting. But she didn't have any other events. She was tired the next day on 01Apr2021. She was up all night in the emergency room. people say that one will be tired, as an effect, but she can't say that it is because of the vaccine, or if she only had 3 hours of sleep. She hasn't been sleeping but she can't attribute it to the vaccine. She can't attribute this to the vaccine, that she has been tired lately and not sleeping. Event outcome of irregular arrhythmia and Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding was recovered on 31Mar2021, of Arm barely sore was recovered on 02Apr2021, of the remaining was unknown. Information about Batch/Lot number has been requested.
72 2021-04-26 weakness With in one hour patient experienced severe Vomiting and Diarrhea. She had called her Doctors offic... Read more
With in one hour patient experienced severe Vomiting and Diarrhea. She had called her Doctors office. She saw a PA which told her to drink more water. She experienced Uncontrollable Diarrhea For 18 days. She was sent to Hospital by ambulance on Monday March 15, 2021. She was was treated with an IV and sent home discharged with Weakness. She continued to have Uncontrollable Diarrhea to were she was wearing Diapers. She fell from Weakness on March 16, 2021 to the point where she laid on the floor for an hour and half before she could drag herself up. She went to Hospital on March 18, 2021. Her blood pressure dropped and was admitted to ICU on the March 18th. She started suffering from a Heart attack and was taken back to have a stent put in her wrist to help with possible heart blockage. She went into cardiac arrest and passed away.
73 2021-01-05 tingling, numbness, flushing, facial paralysis The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the pat... Read more
The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the patient called complaining of right eye drooping, right facial tingling, mild shortness of breath, facial flushing and new onset headache. She arrived at ED at 2:06 pm presenting with facial swelling, tingling and shortness of breath. At that time, she stated her shortness of breath had actually improved and stated "probably just nerves". She still had a funny sensation in her face. She denied any focal numbness or weakness in her extremities. She stated she felt a little lightheaded. She had no sensation of throat swelling, difficulty swallowing. Physical Exam in ED: Constitutional: She appears well-developed and well-nourished. HENT: Head: Normocephalic and atraumatic. Eyes: EOM are normal. Neck: Normal range of motion. Cardiovascular: Normal rate and regular rhythm. Pulmonary/Chest: Breath sounds normal. No respiratory distress. Abdominal: Soft. There is no abdominal tenderness. Musculoskeletal: Normal range of motion. Neurological: She is alert and oriented to person, place, and time. Patient has symmetric facial numbness, she has right periorbital swelling causing what appears to be a facial droop however her mouth seems symmetric, she has negative Romberg's, she has full strength and symmetric sensation throughout Skin: Skin is warm and dry. Psychiatric: She has a normal mood and affect.
73 2021-01-11 weakness, pain in extremity Arm pain; headache; tiredness; extreme weakness; This is a spontaneous report from a contactable con... Read more
Arm pain; headache; tiredness; extreme weakness; This is a spontaneous report from a contactable consumer (reported for herself). A 73-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 05Jan2021 13:15 at single dose at left arm for COVID-19 immunization. Medical history included High cholesterol, Fibromyalgia, Protein S Deficiency, Anxiety, known allergies: Scallops. Concomitant medications received in two weeks included warfarin, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluoxetine, clonazepam (KLONOPIN), rosuvastatin calcium (CRESTOR), fenofibrate (FENOFIBRAT). Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, the patient experienced Arm pain, headache, tiredness, extreme weakness. No treatment was received for the adverse events. The report was non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
73 2021-01-15 numbness Facial numbness Narrative:
73 2021-01-17 numbness gait disturbance with visual symptoms for 4 days, numbness of left side of face, flare of cold sore
73 2021-01-18 night sweats, breast pain Part of lip went numb right after, started getting nauseous, threw up several times. right breast ac... Read more
Part of lip went numb right after, started getting nauseous, threw up several times. right breast ached. Slept all day yesterday. since injection no apatite. Had night sweats.
73 2021-01-18 weakness, tingling intermittent paresthesias left side of face, left arm and left leg, subjective weakness in the left ... Read more
intermittent paresthesias left side of face, left arm and left leg, subjective weakness in the left leg
73 2021-01-19 night sweats 1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping... Read more
1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping 10-11 hours on both nights. 1/17/2021 Chills and temperatures between 99 and 101.2 degrees 1/18/2021 Temperature of 100.1 degrees in the morning with gradual decline to 98.9 degrees in the evening 1/19/2021 and 1/20/2021 Temperature normal 1/13/2021 to 1/15/2021 Injection site "sore" 1/15/2021 Injection site became hard and painful to the point where I was not able to move the arm without pain at the level of 10 or above which of course limited my use of the arm 1/20/2021 Injection site still painful and difficult to lift or move the arm without pain at a level of 4-5.
73 2021-01-19 tenderness Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swel... Read more
Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swelling back of roof of mouth and tenderness neck glands unilaterally. Difficult/painfulswallowing -takes considerable effort to swallow.
73 2021-01-20 tingling Within 5 minutes after leaving the hospital, my lips and left cheek started tingling. When I got hom... Read more
Within 5 minutes after leaving the hospital, my lips and left cheek started tingling. When I got home, my left cheek was beet red. That went away in a couple of hours, but left jaw up to my ear still feels strange with intermittent tingling in left cheek and lips. Called dr.
73 2021-01-20 weakness, numbness weakness, a rush (like adrenalin or B-12 shot effect), rash on forehead, 3 hives on right cheek, two... Read more
weakness, a rush (like adrenalin or B-12 shot effect), rash on forehead, 3 hives on right cheek, two on right chin, slight breathing issue, slight numbness on sides of tongue and between bottom of nose and top of lips,
73 2021-01-22 burning sensation, flushing Patient experienced flushing and burning of face ~45minutes after receiving the first dose of Pfizer... Read more
Patient experienced flushing and burning of face ~45minutes after receiving the first dose of Pfizer vaccine. Patient returned to the clinic because of the symptoms. Patient notes having a similar reaction to prednisone.
73 2021-01-24 weakness Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body ac... Read more
Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body aches and no strength. Caregiver stated on 1/23/2021 patient was having same symptoms with loss of appetite and fatigue. On 1/25/2021 caregiver noticed 2x2 red spot around the injection site that warm sore to touch. Caregiver reached out to the PCP and was told to keep an eye on red spot and put a damp warm rag on it.
73 2021-01-24 tenderness Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still ther... Read more
Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still there at 5 days after vaccination.
73 2021-01-24 pain in extremity Left arm pain, redness & swelling at injection site
73 2021-01-24 inability to speak, slurring STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME... Read more
STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME WORDS, DIFFICULTY SIGNING NAME, HIGH bp WAS ADMINISTERED EMERGENCY CLOT BUSTING DRUG IV AND THEN TRANSFERRED TO NEUROLOGY HOSPITAL. SYMPTOMS OF SLURRED SPEECH, DISAPPEARED NEXT DAY, WRITING HAND RETURNED TO NORMAL RAPIDLY AFTER IV. SLIGHT HEADACHE REMAINED FOR A COUPLE OF DAYS
73 2021-01-24 numbness, tingling left side of face numb, tingling, redness initially bu gone as of time of call 1/21. Told her to co... Read more
left side of face numb, tingling, redness initially bu gone as of time of call 1/21. Told her to cont to monitor and get evaluated if did not go away in 24 hours or got worse
73 2021-01-25 tingling About 5 minutes afterward had right arm and elbow tingling. About 20 minutes after vaccination had s... Read more
About 5 minutes afterward had right arm and elbow tingling. About 20 minutes after vaccination had self-described sensation of throat tightness and tongue and lip swelling, and "numbness" but NO tingling. About 1.5 hours and symptoms ~90% better. Plan to continue to monitor until symptoms close to 100% better and patient comfortable going home.
73 2021-01-25 pain in extremity, difficulty speaking Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy and sharp ... Read more
Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy and sharp pain pain in eyes hoarse throat
73 2021-01-26 numbness Numbness from forearm down to fingers
73 2021-01-26 cold sweat Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood press... Read more
Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood pressure was 198/91. Per clinical nursing director, EMS called. EMS checked vitals again and blood pressure was 130/82. At that time EMS and patient decided that patient did not need to be transported to hospital at this time. Patient left with husband. At time of departure patient was oriented and reported feeling well.
73 2021-01-26 seizure Systemic: Seizure-Severe
73 2021-01-27 pain in extremity Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely ... Read more
Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely sore. Joint pain increased, involving shoulders, hands, legs, arms, knees and hips. Left hand began swelling on January 23rd and continued so I could no longer see my knuckles and it ballooned and it was hot and very painful. The knees were so bad it was almost impossible to stand from a sitting position and walking was stiff. Could not sleep laying down because pain in shoulders and knees would increase. I went to the doctor on the 26th. he prescribed Prednisolone for one week and I am scheduled to see him next Tuesday February 2nd.
73 2021-01-28 flushing Pt. c/o flushing/burning in vaccinated arm, nausea and light headed.
73 2021-01-28 weakness This is a spontaneous report from a contactable other health professional. A 73-year-old female pat... Read more
This is a spontaneous report from a contactable other health professional. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EV0140, via an unspecified route of administration in the left arm on 03Jan2021 13:00 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Patient was not pregnant at vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included Simvastatin, Gabapentin, Flonase, Claritin and multi (not specified). The patient previously took codeine and experienced allergy. Within two days (on 05Jan2021), patient experienced headaches, body aches, fatigue, nasal congestion. Strength not yet fully recovered ten days out. The outcome of events was recovering. Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
73 2021-01-28 weakness, pain in extremity overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, na... Read more
overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, nausea, dizziness (the last two symptoms were brief)
73 2021-01-29 weakness Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep b... Read more
Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep breaths. Them couldn't get warm. Shivering. Felt fevered but no elevated temp registered. Lasted about another hour. Tired/weak after. Noal next day.
73 2021-01-31 pain in extremity, feeling cold, weakness Flue like symptoms, right arm hurt and felt very cold, body ached, , felt dizzy like vertigo, had th... Read more
Flue like symptoms, right arm hurt and felt very cold, body ached, , felt dizzy like vertigo, had the chills, needed to sleep. went to bed early around 8 and slept through the night getting up once to go to the bathroom. Has breakfast just toast the next morning and had to get back into bed and slept 4 more hrs. Body still aching. slept with heating pad and iced my arm. I felt a little better the next day around 2 pm. I drank lots of fluids and rested the rest of the day. Next day still felt weak. 3 days later feeling ok. I am worried about my next vaccine due on the 14th of Feb. Would like to know what to take. My doctor referred me to you with no instructions......
73 2021-01-31 tingling, flushing, weakness Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjectiv... Read more
Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjective Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness,chest tightness, sweating, and feeling flushed She denied hives, loss of sensation, SOB. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress and tongue swelling. ALLERGY REVIEW OF SYSTEMS Previous Reactions: PCN Objective Vitals Vitals: 01/29/21 1514 01/29/21 1521 01/29/21 1526 01/29/21 1539 BP: (!) 153/97 (!) 154/116 (!) 167/90 (!) 172/84 Pulse: 59 64 59 55 SpO2: 99% 94% 96% 99% Blood Sugar 97 collected at 1500 Physical Exam No Rashes or Hives noted. No facial swelling , no wheezes. HEENT Pharynx is clear without exduate. No facial or tongue swelling. Lungs CTA all wheeze No SOB. Neck is supple. No swelling is noted. pt is anxious and nervous. No sign of anaphalyxis No stridor, no swelling Assessment/Plan Treatment included: antihistamines Benadryl 25 mg, Pepcid 10 mg Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Mild reaction, improving. Pt refused any further medications or assessment at the ER. Her husband will pick her up.
73 2021-01-31 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (patiet). A 73-years-old female ... Read more
Sore arm; This is a spontaneous report from a contactable consumer (patiet). A 73-years-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248) in the Public Health Clinic/Veterans Administration facility, via an unspecified route of administration on 16Jan2021 09:15 AM at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has not had COVID-19 prior to vaccination. The patient did not have any other vaccine in four weeks. Concomitant medication included losartan (manufacturer unknown), levothyroxine (manufacturer unknown), hctz (manufacturer unknown), montelukast (manufacturer unknown, also reported as 'monounsatu'). The patient experienced sore arm on 16Jan2021 at 09:45 AM. The patient did not receive any treatment for the event. The outcome of the event was recovering. The patient has not been tested for COVID-19 post vaccination.
73 2021-01-31 numbness Systemic: Other- SOB, light headed, numb hands. Pulse ox was normal. Patient has a history of anxiet... Read more
Systemic: Other- SOB, light headed, numb hands. Pulse ox was normal. Patient has a history of anxiety.
73 2021-02-01 pain in extremity, weakness, feeling cold she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chi... Read more
she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chills; nausea; She had a terrible headache; Feeling freezing cold; she was going to faint; She thought she was losing her mind; slight pain in her arm/sore arm/sore spot; She feels weak, and is still weak; She couldn't walk; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) via an unspecified route of administration in the left arm on 10Jan2021 at single dose for COVID-19 immunization. There was no medical history. There were no concomitant medications. The patient had the first dose of the vaccine on 10Jan2021 and didn't have a reaction, but had a slight pain in her arm on 10Jan2021. Her sore arm started on 11Jan2021. There was a sore spot and when she would pick up her arm it was sore and achy. No pain, but sore and achy. It lasted for a day or two. She didn't have any symptoms until Saturday the 16Jan2021, this past Saturday she thought she was dying. She had chills, nausea, feeling freezing cold, and had a headache. She thought she was losing her mind. The headache just stopped today. She had the chills that would not stop and she thinks she broke the sweat on Sunday (17Jan2021). She had a little nausea and couldn't eat anything on 16Jan2021. She had a terrible headache, which just stopped about 2 hours ago. She stated she must have to take 10 Tylenol over the course of time, every 4 hours. On Saturday 16Jan2021 she was just laying on the floor in pain. She was not even eating, just drinking water. All of her symptoms stopped this morning around 5 AM (18Jan2021). She had a big sweat. She is unsure if she had a fever because she does not have a thermometer. She is unsure if she has recovered completely from these symptoms. She feels weak, and is still weak (on Jan2021). She cannot go out or get dressed or shower. She is not strong enough. She is just sitting up now, no longer laying in bed. She couldn't walk (on Jan2021) and was afraid she was going to faint on 16Jan2021. She can walk a little bit now and feels a little bit better. She has been out of it for three days, She hasn't felt good. She asked if side effects can appear 6 days later? Is this normal to have a reaction 1 week after getting it? She asked are the side effects worse after the second dose? She asked is this Covid or side effects, what are the COVID symptoms? She asked should she take the second one if she had these side effects? Caller clarifies this is the Pfizer COVID Vaccine. Whoever vaccinated her did not give her the paper about it afterwards. Her neighbor brought it to her cause they went together. She did not realize she could experience these things. She did not expect them a week after getting the vaccine. She thought she had COVID. She asks, "do you think I have COVID?" She is just now getting better and it has been 3 days of experiencing these symptoms. Should she get the second vaccine? She is trying to do the right thing. Event outcome of chills, nausea, feeling freezing cold, and headache was recovered on 18Jan2021, for was going to faint and couldn't walk was recovering, for weak was not recovered, while for others was unknown.
73 2021-02-03 tenderness PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADA... Read more
PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADACHE, AND NAUSEA FOR 24 HOURS.
73 2021-02-03 unresponsive to stimuli Patient's primary care provider received a death certificate to be signed for this patient. He spoke... Read more
Patient's primary care provider received a death certificate to be signed for this patient. He spoke with the patient's husband and son, who reported that the patient had pain and swelling at the vaccine administration site after receiving the vaccine and was feeling unwell after receiving the vaccine. The patient's family reported that they found her unresponsive on 2/2/21 and called 9-1-1. The patient was pronounced dead upon arrival of emergency responders.
73 2021-02-03 tingling Systemic: Other- TONGUE, LIPS AND NECK NUMB AND TINGLING-Mild
73 2021-02-03 cold extremities, feeling cold, pain in extremity flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ... Read more
flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ache; changes from her lower extremities freezing and sometimes it was her whole body; changes from her lower extremities freezing and sometimes it was her whole body; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 at a single dose for covid-19 prophylaxis; apixaban, oral from an unspecified date and ongoing at 5 mg, twice daily as blood thinner medication and atrial fibrillation. Medical history was not reported. Concomitant medication included ongoing dronedarone hydrochloride (MULTAQ) for blood pressure and heart beat, ongoing pravastatin for cholesterol, and dronedarone for blood pressure. For the past couple of days, she had had flu like symptoms. She has had a headache, body aches and chills. It changes from her lower extremities freezing and sometimes it was her whole body. Patient also had a pain in arm. Her left arm was bruised - still black and blue. All of these occurred on 13Jan2021. She did not have a fever. Today (20Jan2021), she was ok. When they went through the check in they asked if patient was on a blood thinner and she was. The patient's husband was wondering if the reactions had anything to do with the vaccine and if the blood thinner medication (Apixaban) she was taking would have caused the bruise. The patient was supposed to get the second vaccine 02Feb2021. Reporter was asking if it is ok to get the second dose. The action taken in response to the event for apixaban was unknown. Outcome of event chills was recovered on 19Jan2021, after 6 days; events flu like symptoms and lower extremities freezing and sometimes it was her whole body was unknown while recovering for other events.
73 2021-02-03 cold extremities, feeling cold, pain in extremity the thermometer that marked 100°F orally (she says that the fever was higher in the night); States ... Read more
the thermometer that marked 100°F orally (she says that the fever was higher in the night); States she is shrinking. Weight varies; cough; 86 of oxygen saturation/O2 saturation was anywhere between 86-88; pulse was 133/rapid pulse, it was 133/rapid heartbeat; her breathing was above 94; shooting pain/stabbing pain at the injection site/extremely excruciating stabbing pains in her arm with the shot; shivers; headache/splitting headache; freezing; slight breathing difficulty; slight body aches; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), via an unspecified route of administration on 15Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included high blood pressure diagnosed 15 years ago, maybe; High cholesterol diagnosed 20 years ago, she doesn't know, reflux diagnosed 20 years ago, maybe more, prediabetes and allergy induced asthma which she carries an inhaler, and she has used it maybe three times a year. Patient reported that she was tested and they don't know for sure, but she reported that she may have allergy induced asthma as she has to take, carries an inhaler, and she has used it maybe three times a year, in the fall when leaves are falling down, the leaves get moldy, and she was driving in her car, or walking in a wooded area, she gets tightness, takes her inhaler and was fine, that's the extent, no other circumstances; fall or she had where a plant was blooming outdoors, she gets tightness, and she took her inhaler, and was good for the next year, so sitting in the environment and nothing further materializes, if she takes the inhaler three or two times a year, considering what other people have, she thought this was insignificant. There were no concomitant medications. The patient reported that she got vaccinated this Friday and had nothing but a sore arm afterwards, on 16Jan2021 and was fine all day, evening, all day Saturday. She just had soreness at the site, she had no redness at the site of injection, but the weird part: she doesn't think anyone would believe, 33 hours later, at midnight, she was still up, on her way to bed, and all of a sudden she experienced extremely excruciating stabbing pains in her arm with the shot, it was stabbing, excruciating, and immediately at the same time, she had shivers/shivered and had a splitting headache, was freezing and had to put socks on, and had noticed very slight difficulty breathing, and since it was midnight, she didn't want to wake up her husband, she dozed off, and was up at 0530. She had body aches, slight, it was the least, but the stabbing stopped in her arm. She slept from 12:30 to 05:30, and the shivering and aches stopped, but the headache was still on, so she took a pill for the headache. She took the thermometer that marked 100F orally; she stated that the fever was higher in the night and she assumed with the shivering, she had a greater fever than 100. Also, the oximeter indicated 133 pulse and 86 of oxygen saturation. By 10:00, it all had resolved. She has an oximeter, and since she still had the feeling of difficulty breathing, she put it on, but her pulse was 133, that was when she was feeling better. It was reported that all symptoms were gone except for rapid pulse, it was 133 and the slight breathing, and her 02 saturation was anywhere between 86-88, it varied, and by 10:00, all issues resolved, her heartbeat was down to normal, her breathing was above 94, or whatever, everything was fine, and has been fine since then. Maybe she had fatigue on Saturday and Sunday, on Sunday was like after the flu, after you finish, you have fatigue and was a little out of it, this was on Sunday. On an unspecified date, the patient stated that she was shrinking and weight varies. Patient stated that the only thing she does have, says she has a cough, but because she needs a drink, she was not sick and she gets to drink water. She felt like the reaction she had was in the limit of a severe allergic reaction due to the rapid heartbeat and her difficulty breathing. She would like to know if there was information about these side effects reported so she can determine if she was going to have the second dose of the vaccine. Outcome of events states she was shrinking, weight varies and cough was unknown; and outcome of the rest of events was recovered on an unspecified date.
73 2021-02-04 burning sensation, flushing Headache A severe feeling of burning on my facial skin and a flushing of the skin My forehead felt... Read more
Headache A severe feeling of burning on my facial skin and a flushing of the skin My forehead felt as though I had a severe sunburn A slightly elevated temperature: normal is 97.3 elevated 98.6 All day 02/01, Partial day 02/02, Redness gone and feeling of burning less severe 02/03 and 02/04. 02/05 a couple of episodes of sensation of facial burning and slightly elevated temp
73 2021-02-04 numbness Left hand numbness approximately 15 min after vaccine on thr left deltoid. Pt was really anxious how... Read more
Left hand numbness approximately 15 min after vaccine on thr left deltoid. Pt was really anxious however the hand numbness improved after 20 mins of rest and relaxation. Initially pt was hypertensive however after resting BP improved
73 2021-02-04 pain in extremity tired; mildly sore arm; This is a spontaneous report from a contactable nurse (patient). The 73-year... Read more
tired; mildly sore arm; This is a spontaneous report from a contactable nurse (patient). The 73-years-old female patient received bnt162b2 (BNT162B2, lot number: EL3302, Expiry Date: 31May2021) via an unspecified route of administration in Left arm on 21Jan2021 10:45 at SINGLE DOSE to gain immunity against Covid-19. Medical history included asthma well controlled Diagnosed 6 years ago. No Prior Vaccinations within 4 weeks. There were no concomitant medications. The patient experienced mildly sore arm on 21Jan2021, tired on an unspecified date. The AEs did not require a visit to emergency room or physician office. The outcome of the event mildly sore arm was recovering. No follow-up attempts possible. No further information expected.
73 2021-02-06 involuntary muscle movements Acute intractable generalized abnormal movements. Writhing, choreiform movements x3 days until prese... Read more
Acute intractable generalized abnormal movements. Writhing, choreiform movements x3 days until presented to hospital. Given Ativan 2 mg IV and Keppra 1g IV with resolution
73 2021-02-06 pain in extremity Redness, swelling, aching, pain, in the arm where injection was administered.
73 2021-02-07 pain in extremity Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her ... Read more
Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her hips and legs; Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her hips and legs; her arm was sore yesterday but better today/her arm was sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration in left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing 'sometimes her hip and leg would hurt prior to getting the vaccine'. There were no concomitant medications. Caller received the covid shot on Wednesday, 20Jan2021, her arm was sore yesterday (21Jan2021) but better today (22Jan2021). Caller reports worsening hip and leg pain on 22Jan2021 because sometimes her hip and leg would hurt prior to getting the vaccine. Caller would like to know if it's okay to have taken Tylenol for her symptoms after taking the covid vaccine. Response: The interim ACIP guidelines note that, "Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time.& quot; If you are a patient, you should discuss this with your healthcare provider. Caller would like to know how long the symptoms from the covid vaccine would last. Calling about the Pfizer COVID vaccine she took it on Wednesday (20Jan2021), the Pfizer Biontech, and yesterday (21Jan2021) her arm was sore all day, which is probably to be expected, but today (22Jan2021), she has, her hips and legs feel real achy, she has achiness in her hips and legs, it was asked if that is normal. it was asked if it is a side effect from the shot. Her arm is not like it was yesterday (21Jan2021) if the achiness was a side effect, she thought she may have had it yesterday (21Jan2021), but she didn't, just today (22Jan2021). The outcome her arm was sore yesterday but better today/her arm was sore was recovering. The outcome of other events was not recovered.
73 2021-02-07 unresponsive to stimuli Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weir... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weird", reported nausea and shortness of breath, and were found to have a blood pressue of 200/96 mmHg despite taking blood pressure medications that day. Patient was transported to the emergency department during which they had a brief episode of unresponsiveness and were non-interactive. On initial exam in the emergency department patient symptoms were improving: speech, sensation, and cranial nerves are intact, normal strength in all extemities, lungs are clear, and there is movement in all extremities. No rash, wheezing, or respiratory distress noted. Repeat vitals within normal ranges except blood pressure 151/87. Patient administered medication for nausea. Symptoms resolved and patient discharged to home stable.
73 2021-02-07 weakness she has probably shrunk in height; 5am on 21Jan2021, for the whole day i had a fast heart rate, 125b... Read more
she has probably shrunk in height; 5am on 21Jan2021, for the whole day i had a fast heart rate, 125bpm; blurry eyes; dizziness; Her blood pressure was also up; In the morning of the 20Jan2021 I was weak; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 19Jan2021 10:02 at a single dose for Covid-19 immunization. Medical history included ongoing Seasonal Allergies (probably started in the last 4-5 years; reoccurs every year from about Oct through Mar), ongoing high blood pressure since like 2006 or 2004, ongoing Iliac artery stent placed started couple of years ago, anxiety from 2010 and ongoing (her cardiologist put her on Xanax around 2010-ongoing). Concomitant medication included ongoing alprazolam (XANAX) since 2010 for anxiety. She gets the flu shot every year and has never had a problem with the flu shot. She got her last flu shot in Oct2020, no adverse events with that or other flu shots historically. On the second dose of Pneumococcal vaccine, it swelled her arm up from the injection site all the way down to her wrist; she went to the urgent care for that. They gave her some medicine and eventually the adverse event went away. She experienced some side effects following that injection. The patient reported that in the morning of the 20Jan2021, she was weak and just kind of rested. She did not have any other side effects until 21Jan2021. At 5am on 21Jan2021, for the whole day she had a fast heart rate, 125bpm, she woke up with her heart rate up, fast heartbeat, then down to 110 and then just toggled a little bit, she had blurry eyes so she could not really focus her eyes, weakness and dizziness. These events continued all throughout 21Jan2021 but her heart rate came down, it was running in the 90s and she was weak all day. Her blood pressure was also up on 21Jan2021. She thinks the blurry eyes, with her eyes being squirrely was related to her heart rate being up and blood pressure being up. She feels like she recovered completely from these events by this morning 22Jan2021. She feels good, strong and her eyes are clear today, felt better than yesterday but not 100%. She has probably shrunk in height, her last known height was 5' 9. She called to ask if she should or should not get the second dose as scheduled for 12Feb2021 in response to the side effects. Outcome of the event 'she has probably shrunk in height' was unknown while the rest of the events was recovered on 22Jan2021. No follow-up activities are needed. No further information is expected.
73 2021-02-09 pain in extremity sore arm; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-o... Read more
sore arm; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at arm at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. patient asking if one have a sore arm, are one allowed to take Ibuprofen. Female consumer received the first dose of the COVID-19 vaccine today and had a sore arm (25Jan2021). When she received the vaccine, it was administered closer to her shoulder. patient asked what does intramuscularly mean. Outcome of the event was unknown. It was a non-serious report. Information on the lot/batch number has been requested.
73 2021-02-14 tremor Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood press... Read more
Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood pressure 193/94; shakiness; This is a spontaneous report from a contactable consumer (patient) reported for that a 73-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) , via an unspecified route of administration on 30Jan2021 14:30 at single dose at right arm for covid-19 immunisation. Medical history included blood pressure. Concomitant medication included pantoprazole, metoprolol, atorvastatin, metformin. The patient previously took Cefdinir and experienced allergy. The patient experienced dizziness with very high blood pressure 193/94, also shakiness, major headache on 30Jan2021 16:30. Adverse event result doctor or other healthcare professional office/clinic visit. The patient had EKG. Therapeutic measures were taken as a result of events included unspecified medication. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
73 2021-02-16 nerve pain Started having neck and L shoulder pain on 2/6. Continuously got worse and on 2/12 went to PCP. Dx a... Read more
Started having neck and L shoulder pain on 2/6. Continuously got worse and on 2/12 went to PCP. Dx a pinched nerve. On 2/13 at 2:23pm, my whole L arm broke out in vesicles. Went to ER. Dx with Shingles. Started on Valtrex 1ooomg TID and Prednisone 50mg daily x5 days. V.esicles continued down into my L hand and fingers. Nerve pain continued to be severe. Went back to PCP on 2/16. Started on gabapentin.
73 2021-02-16 pain in extremity Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joi... Read more
Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joint and muscular aches. Then progressed to persistent productive cough. No fever during this time. These symptoms lasted until 2/15/2021.
73 2021-02-16 pain in extremity, muscle spasms psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible ... Read more
psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible palsy, as if her muscle was being pulled like a rubber band; the worse bowel movement. She had to go the bathroom a lot; Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening; muscle cramping and pulling; Her toes would contort and go backwards.; she feels like the left arm is going to do something, its like the last to be pulled; shingles; muscles became tight/contort; minor nausea; Stomach cramps; Gas; Indigestion; became weird in her head, almost like a lightheadedness; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on 30Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included fever, being ill (deathly ill and it lasted for three weeks) and bug bites from an unknown date and unknown if ongoing. There were no concomitant medications. The patient is the type of person that takes a lot for her to take medications. She is allergic to a lot of things; she always has crazy reactions. She can't take morphine. It took her 7 pills to get the right one for high blood pressure. She has the craziest one-day reactions. She received the COVID-19 vaccine on Saturday much against her will, knowing she had COVID but not diagnosed in March. She had a fever, she was deathly ill and it lasted for three weeks. She had a nasal swab done and it came back negative. She doesn't think that was right, she believes she had COVID-19 in Mar2020. Her daughter is younger, and she had the same thing, she couldn't breathe good for 3 weeks. She had pneumonia. She knows she had COVID-19. She was trying to lose weight. She was given her first COVID-19 vaccine by a doctor. Everything was going okay at first. About an hour and a half later, she became weird in her head, almost like a lightheadedness. She can't describe it. She has never taken drugs. She doesn't drink alcohol at all. She has like a virgin body. She states plus she is red headed, which it is known red heads have a harder time with medication. As the day goes on, she just felt lightheaded all the rest of the day. The next day (Sunday, 31Jan2021), she wakes up and it hits her like a ton of bricks. She woke in the morning and seemed to be okay and then it was like she was pregnant and blew up. She started cramping really bad and had gas. Everybody has gas. She was a little nauseated as well. She experienced lots of indigestion, cramping in her stomach like she was going to have a baby or the worse bowel movement. She had to go the bathroom a lot. She had a little bit of nausea. She had nausea pills because she had a gallbladder taken out and she took nausea pills for 2-3 days. She didn't take any medication for any of these symptoms she started to experience on Sunday. However, she did start popping Gas-X. She was taking two Gas-X every 3 or 4 hours. The caller states it helped. She had lots of gas; gas was just coming out of her bottom. She had the gas, cramps, her stomach hurt. She was able to get through it, which that is good. Then Monday, 01Feb2021 was the day she had weird things happen to her that she was kind of concerned about. Her muscles started to draw, that is the best way she can describe it. Her feet would just draw up weird. Her arms and hands would do crazy things and contort or draw up. This hurts because the muscles are like a rubber band pulling. It was weird, and she didn't like it. It wasn't like when she has a horse and has to get up and stand, it wasn't like that at all. Her muscles were tightening up like a rubber band. Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening. She thought to herself, "what is this Parkinson's?". She doesn't even know. She still has some stomach issues, but it is easing up. The gas is still coming out. It wasn't debilitating or anything. She has some minor nausea. What scared her more was the muscle cramping and pulling. Her toes would contort and go backwards. The muscle tightness occurred yesterday, 01Feb2021. It happened all day and was sporadic. Her toes moved in a different way like a rubber band pulling on muscle. Nothing has happened today. Everything was yesterday. Her whole body basically was affected, just different sections at different times. Today, she feels like the left arm is going to do something, it's like the last to be pulled. Her hands and fingers stayed the same. She explains like the upper arm area from her elbow to her shoulder part. She can't even think of what that area is, but it's the part between her elbow and shoulder. She has been doing lots of exercises and moving, hoping the part of her elbow to her should don't atrophy or won't pull. She hasn't told anybody about it. She doesn't like it. It was very frightening. She is scheduled for her second shot and she is scared to death to go back. She mentions her nerves are shot. From stress, she had previously broken out instantly. She thought it was a bug biting her. She never had gone to the doctor but after about 4 weeks, she thought she had these horrible bug bites. She was shaking her clothes and she almost wanted to strip it was so bad. She thought it was severe bug bites. She couldn't figure it out. She finally went to the doctor after a week. It was a Saturday. The doctor told her it was shingles. Explained that it itches a lot. She went on medication. She clarifies she went on acyclovir 800mg, three pills a day. She called her doctor knowing that she had shingles and how scared she is with medicine, the doctor assured her she could get the COVID-19 shot as scheduled. The medicine for shingles (acyclovir) was finished up the Friday before she received the COVID-19 vaccine. She got the shingles shot at 60 but everybody is now saying to get the new shot for shingles which she has never done obviously since she got the shingles. She plans to get the shingles shot in the summer. She is not worried about it. She took 3 pills a day and that was fine. She is fine, meaning every day she did normal things going through the whole process. She states she plans to go to the bank. She asked if anybody has reported the reaction she experienced after receiving the first dose of the Covid vaccine. She received the first dose of the vaccine last Saturday, in which within an hour and a half her "brain got weird, like a psychedelic feeling and it felt like I was getting an injection in the operating room to go to sleep." On Monday she experienced, "horrible palsy, as if her muscle was being pulled like a rubber band." Stated that it wasn't a horse feeling. Her hands and fingers would pull and contort in different positions, in which they would remain tight and stay in that position, and then she would be able to make a closed fist. On Monday night, her left arm contorted (which is not administration arm) and her muscle became really tight from her elbow to her wrist leading to her hand contorting as well. She describes the muscle tension as if a rubber band was being pulled, it would have burst. This muscle pulling hurt, in which she took 3 ibuprofen (ADVIL). She has crazy reactions with almost anything that she takes. She has never smoked or drank. The patient underwent lab tests and procedures which included COVID-19: unknown on an unspecified date and unknown on Mar2020, SARS-COV-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of gas (flatulence), muscles became tight/contort, minor nausea, horrible palsy, as if her muscle was being pulled like a rubber band and shingles. The outcome of the event 'the worse bowel movement. She had to go the bathroom a lot' was not recovered while of the rest of the events was unknown.
73 2021-02-17 weakness, pain in extremity At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely d... Read more
At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered. The information on the batch number has been requested.
73 2021-02-21 tingling After receiving her vaccine client stated that she feel a tingling sensation in the mid upper back a... Read more
After receiving her vaccine client stated that she feel a tingling sensation in the mid upper back area. Vital signs obtained by EMS. Bp 121/78, HR 82, O2 sat 97%, Blood sugar 120. Client states she feels better and discharged home by EMS.
73 2021-02-21 pain in extremity The morning after she got her shot, she experienced sharp pain in thumb. It has been 6 days since s... Read more
The morning after she got her shot, she experienced sharp pain in thumb. It has been 6 days since she got the shot and she is still experiencing the sharp pain.
73 2021-02-21 weakness This is not a critical reaction but want to report in order to help build up the information availab... Read more
This is not a critical reaction but want to report in order to help build up the information available to healthcare professionals going forward. Morning after chills, neck stiffness, pain back of head left side. Applied heating pad to neck. By late morning I was nauseous , and weak as a kitten. Took a 500 mg Tylenol and slept for about 4 hours. Woke up in a sweat but chills gone and am now able to eat a little bit. Back of head and neck still very sore. The injection site is sore but no rash; right arm seems to have "phantom pain" as well ( I experienced this with Shingles shot in December 2020 too).
73 2021-02-21 muscle spasms, pain in extremity Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 1... Read more
Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 18 hours. Had to use heating pad and massage to help feet relax from en pointe position so I could walk to the bathroom. Legs were sore after 18 hours but not cramped . Also massive headache made my eyes light sensitive all day Saturday and Sunday until about 9PM. Extreme exhaustion. Recovering today, Monday. Still tired an s slight residual headache at times but not bad enough for painkiller.
73 2021-02-22 pain in extremity After 15 minutes of the vaccine she left and when she got home had an anaphylactic reaction, had to ... Read more
After 15 minutes of the vaccine she left and when she got home had an anaphylactic reaction, had to use her Epi-Pen. Did a telemed appointment with her physician who told her to take one dose of the Epi-Pen, Benadryl, Prednisone, Ventolin, and Singulair. These medications have worn off, and wants her to take even more doses of the Prednisone, Benadryl and the inhaler. She is still having symptoms, but improving. She does not itch as badly. Her arm is sore.
73 2021-02-23 tingling, numbness About 20 minutes after vaccine, the right side of my face (including nose, some of my tongue) felt n... Read more
About 20 minutes after vaccine, the right side of my face (including nose, some of my tongue) felt numb or tingly. Very mild. Symptoms disappeared within, say, a half hour and did not return. The following morning I had fleeting head aches on right side - each lasting a' second or so only, and several hours apart. By the afternoon they disappeared. I am having no other symptoms. My arm never hurt at the injection site. I'm not even concerned but feel I should mention this reaction because I will be getting a second shot on March 16. Is it safe? Again, I have no symptoms any longer and feel great.
73 2021-02-23 pain in extremity Pfizer COVID 19 vaccine given 01/22/21. Patient reports severe arm pain the following day. She pre... Read more
Pfizer COVID 19 vaccine given 01/22/21. Patient reports severe arm pain the following day. She presented to ED and was seen by a provider who believes she may have bursitis or tendonitis secondary to the vaccine. I followed up with her 02/16/21 and she is still experiencing severe pain and unable to use that arm. She has an appointment scheduled with an orthopedic specialist 02/18/21 for further evaluation.
73 2021-02-23 cold extremities Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and contin... Read more
Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and continued upset stomach. Sunday night slight cramping in stomach. Monday AM Full blown cramping , afternoon 99.2 fever, chills, hands cold continued severe cramping. Took Tylenol. Tuesday slight cramping from stomach to rectum, normal temp. Wednesday slight cramping comes and goes. Feeling much better.
73 2021-02-23 tingling pt felt vague tingling in her head and then it went down to her feet. Initially on the R then resolv... Read more
pt felt vague tingling in her head and then it went down to her feet. Initially on the R then resolved then on the left then resolved. She also felt like her lungs were feeling weird. This gradually improved over the course of an hour.
73 2021-02-24 weakness COPD on 2L BL O2 requirement, hypothyroidism, cachexia, GERD with similar presentation earlier this ... Read more
COPD on 2L BL O2 requirement, hypothyroidism, cachexia, GERD with similar presentation earlier this month post-covid vaccine # 1, who presetned for feeling sick and SOB. Patient received her second dose of the covid vaccine on 2/19/21, 3 days prior to presentation. The following day, she started having "breathing issues" so she was given a dose of prednisone. 1 day prior to presentation, her breathing had improved but she was feeling generally sick, so she was given tylenol but not pred. Then, today, day of admission, patient was having bodyaches, weakness, headache, and breathing issues again. She took prednisone this morning, but still had to turn up her O2 because her work of breathing kept fluctuating. Admitted 2/22/21 ? 2/24/21.
73 2021-02-24 feeling cold, weakness, muscle spasms On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, ch... Read more
On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, chills, ear ache, pain level 8. Felt sick all over, like having the flu and then whole body ached, not just GI track. Left arm injection site was red, sore to touch, swollen (slightly). Doctor couldn't get vaccination needle into arm muscle the first time and so had to try a second time. Intense cramping of GI track started up again 8:45AM on Feb. 13th. By 4PM Feb. 15th fever 102F, chills, felt freezing cold and had to wrap myself in a heating blanket. Pain level 10, especially in pancreas. Fever broke around 2:30AM Feb. 16th and later when I was up at 8AM I felt very weak, faint, pancreas ached. Pancreatic pain lasted another 3 days. Pancreatic pain stayed around level 5. On Feb. 17th took ibuprophen. Pain level reduced to 1. This was the only time that I took pain medication between Feb. 10th and 17th, because I am conservative about using Ibuprophen, Tylenol, and have a high threshold for pain.
73 2021-02-24 numbness, pain in extremity Progress Notes Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 ... Read more
Progress Notes Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 Date: 2/25/2021 Subjective is a 73 y.o. female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L arm/hand numbness . She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH: none per pt. Not on any medication. She has not been back to her pcp for "several years". No known hx of htn. She does have a bp cuff at home. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/25/21 1118 02/25/21 1136 BP: (!) 172/84 124/82 Pulse: 96 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. No sensory deficit. Motor: Motor function is intact. No weakness. Coordination: Coordination is intact. Coordination normal. Gait: Gait normal. Comments: +5/5 strength to upper and lower extremities. Equal facial movement. Psychiatric: Mood and Affect: Mood is anxious (slightly). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Exam is stable/unremarkable. VS improved after monitoring. Pt monitored for 20 minutes. She feels well. More like anxiety than local reaction. Pt aware of what to watch for. Education on monitoring bp at home and recommended that she follow up with pcp sometime next week to get up to date on her physical and follow up on bp records she will have done at home. Electronically Signed 2/25/2021 11:33 AM
73 2021-02-24 tingling, weakness, pain in extremity, numbness Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely t... Read more
Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely tired and sore arm that day. Day 2 - tired easily, no stamina. Dizzy and nauseous after showering at3:30 pm. By 10:30, both hands were red and itched. Sometime in the night woke with a very sharp, painful headache. Did not last. No real problem again until Saturday. Nausea at 11:20 am. Sunday I sat all day doing taxes - no symptoms noted. Monday after walking - rapid heart rate and very tired after what is normal activity. By 4:30 I was tingling all over my body. Tuesday night my ankles are swollen for the first time in years. Only happened that nigh. Wednesday morning, the tingling is very strong in my calves. and I had a sharp pain in the area of my Achilles tendon. I believe that the vaccine has exacerbated the neuropathy (undiagnosed) of the bottom of my feet. Today I am reporting because I fell for no reason getting out of a chair, and the tingling is in my legs, arms, shoulders. I had not heard until today that the vaccine could affect the nervous system. The effects are the worst they have been and it has been one week since I had the vaccine. Should I get the second shot? Due March 11,2021.
73 2021-02-24 tremor, hot flush swelling of face and forehead, hot flashes. tremors pulse rate low, elvevated blood pressure
73 2021-02-25 tingling After about 10 minutes after receiving vaccine patient complained of shortness of breath, tingling d... Read more
After about 10 minutes after receiving vaccine patient complained of shortness of breath, tingling down to her fingers and feeling strange. I gave her 1 dose of EpiPen at site of injection. She did start feeling a little better. Paramedics came and she was transported to the hospital. I did speak with her later and she was feeling better. She did tell me that they didn't think it was an anaphylaxis reaction but a reaction to the vaccine
73 2021-02-25 numbness, flushing Client c/o numbness and hot flush to the face w/slight lightheadedness. Client verbalized that she ... Read more
Client c/o numbness and hot flush to the face w/slight lightheadedness. Client verbalized that she had not had anything to eat or drink due to nervousness of vaccine. Client seen and assessed by EMS. Vital signs are BP 132/70, HR 90, o@ 99. Client advised to drink and eat snack that she had in the car. After snack, client cleared to go home by EMS. Client also advised to seek medical attention if symptoms worsen.
73 2021-02-25 weakness Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This ... Read more
Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.
73 2021-02-25 discomfort Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain an... Read more
Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain and inability to support my weight, this lasted for three days with 2nd day being the worst pain and discomfort. Also had a headache for most of the day on the second day. Four days following vaccine I started to notice the injection site was getting itchy, then on day Five it was increasing and started getting red, swollen, hot and itch increased. Day Six it is still itchy, red, hot and swollen. Red site is about the size of an orange. As of Day Six, No fever, headache or other symptoms and knee has returned to normal discomfort.
73 2021-02-25 weakness ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching i... Read more
ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching in her shoulder, into her back; aching in her shoulder, into her back; weak and unable to function; weak and unable to function; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), intramuscular on 16Jan2021 1:45 PM at a single dose on the left shoulder, right at the very top for COVID-19 immunization. Medical history included ongoing lupus since 1999. Concomitant medications reported were none. The patient experienced aching in her shoulder, into her back, dizziness, she was not quite herself on 16Jan2021; she ran a fever of 101 degrees, had lots of chills and sweating on 18Jan2021; she became weak and unable to function, and tired on an unspecified date in Jan2021. The patient stated she got the first dosage of the COVID-19 vaccine and had some side effects. She received the first COVID-19 vaccine on 16Jan2021. She had some aching in her shoulder and stuff on 16Jan2021. For 2 days, she was weak and unable to function. She ran a fever of 101 degrees on 18Jan2021 and was sweating head to toe. At the time of report, she currently had no fever, but was feeling very fatigued. She stated she is trying to make her next appointment, but she can't pull up the paperwork. She wants to know what to do about the side effects. Her next appointment on 13Feb2021. Her shoulder hurt an hour after she received the vaccine on 16Jan2021. That night and the next day, the whole shoulder even into her back started hurting. Like when she rolled over and laid down, she would say "ohhh, I can't lay that way". This lasted for a couple of days. Her shoulder is still tender, but it is much better. She can lift it up, move it around and it's not causing her any difficulty. She stated she became weak. The first night after receiving the vaccine in the middle of the night, she kind of had like a dizziness, she was not quite herself. She thought it was just part of the vaccine. The next day, she couldn't do anything. She was down for 2 days after that. On the 17Jan2021 and 18Jan2021, she was feeling really happy. On 18Jan2021, she started to have a fever. She had a fever that night and part of the next day. She had lots of chills. The fever and chills have seemed to go away. She just feels really fatigued after. She woke up twice and her whole body was soaked. She states that is all gone now. She has had no fever. She had a very good night last night. She stated her aches and pains were at a minimal. She stated she is 73 years old, so she is going to have aches and pains as it is. At the time of the report, all she has is fatigue. She added that the fatigue isn't coming from her, it's from the vaccine. She was very active usually. But at the time of the call, she would get up to do a little and then she would have to sit back down. She was very tired. She was feeling weak and out of pocket. She was so tired. She didn't want to do anything. She stated she must find someone who can print her new paperwork. She plans to call her doctor and see what he thinks about her receiving the second shot. She feels she really needs to get the second shot. During the report, she made the comment "I'm sorry, I'm choking on my cough". The patient underwent COVID-19 test on 14Jan2021 with result of negative. She also underwent blood test on an unspecified date with unknown results. The reported adverse events did not require a visit to the physician office or emergency room. Outcome of the event fatigue was not recovered, while outcome of the other events was recovered on an unspecified date in Jan2021. Information on the Lot/Batch number has been requested.
73 2021-02-26 bell's palsy, slurring Day after second dose symptoms thought to be a stroke occurred. Patient was given a clean bill of h... Read more
Day after second dose symptoms thought to be a stroke occurred. Patient was given a clean bill of health at ER in hospital. Following day 2/16/2021 patient went to clinic to find out why face was dropping and speech was slurred. Primary Care Provider diagnosed patient as having Bell's Palsy (see physicians report).
73 2021-02-26 flushing, feeling hot Itching from head to toe; high blood pressure; flushed and warm
73 2021-02-26 feeling hot, pain in extremity Low grade fever, headache, fatigue , arm pain and heat.
73 2021-02-26 flushing PATIENT BECAME DIZZY, FLUSHED AND SLIGHTLY RED ON ARM AT SITE. GIVEN 25 MG BNENDRYL. SYMPTOMS RESOLV... Read more
PATIENT BECAME DIZZY, FLUSHED AND SLIGHTLY RED ON ARM AT SITE. GIVEN 25 MG BNENDRYL. SYMPTOMS RESOLVED WITHIN 30 ADDITIONAL MINUTES .
73 2021-02-26 night sweats extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no tast... Read more
extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no taste, extreme thirst rash on front of both legs and both arms,night sweats, runny nose
73 2021-02-27 discomfort Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Ch... Read more
Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: DEATH-Severe, Systemic: Heart Attack-Severe
73 2021-02-27 pain in extremity Sore arm for 24hrs, chills and low grade fever (99.1). 28 hrs
73 2021-02-28 weakness, pain in extremity Headache nausea chills weakness severe arm pain right arm . Recovered in 10 hours followed by ... Read more
Headache nausea chills weakness severe arm pain right arm . Recovered in 10 hours followed by slight headache for several days.
73 2021-02-28 discomfort I developed a rash (in the evening and continued all night). The instructions I received was to see... Read more
I developed a rash (in the evening and continued all night). The instructions I received was to seek medical attention. I went to Urgent Care at 8 AM on Feb.25. I was instructed to take one tablet Claritin and then 2 Benedryls in the evening. By 5:30 PM on Feb 25 I was extremely uncomfertible and took two benedryls. Still could not sleep and at 11:30 PM took 2 more benedryls. When I woke up at 7:30 AM on Feb 26, the rash was gone and has been gone since. I was also instructed not to take the second shot. (Which I will not)
73 2021-02-28 pain in extremity Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep becaus... Read more
Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep because I was just uncomfortable all over. Felt a little light headed. At 7:00 took temp,99.2,- my normal is around 97.7. Right arm was feverish and extremely sore,more so than first vaccine. All that day fever went up to 101.2 by the afternoon. Drank liquids all day. had a headache most of the day with all over joint pain. Never had the flu but think this must be how you feel. Fever broke around 3:00AM on 2/26. Upper arm remains sore, swollen,red and feverish as of today,3/1
73 2021-03-01 pain in extremity Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous... Read more
Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included medroxyprogesterone and estradiol. The patient previously took the first dose of BNT162B2 in Jan2021 for COVID-19 immunization (got the first shot exactly 3 weeks before for which the patient was not sure of the date). On 01Feb2021, just shortly after the patient and his husband both got the shot, the patient had sore arms by the time they drove home yesterday afternoon. The patient's sore arm was much better today but it was still just little tender - that is the only thing she had. Currently (02Feb2021), the patient's arm was slightly stiff still, just the muscle is slightly sore. No treatment was taken for the adverse events. The patient was recovering from "Sore arms; just little tender". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
73 2021-03-01 weakness Chills and fever began at approx. 1:30 a.m. on February 27. Continued until late mid-day on March 1... Read more
Chills and fever began at approx. 1:30 a.m. on February 27. Continued until late mid-day on March 1. Extreme weakness and nausea. Had no appetite. Very dry mouth. Fever lessened by evening of March 1. Weakness and feeling of lightheadedness continuing as of today, March 2, morning. No more nausea today. No fever today Able to eat small amount of food
73 2021-03-01 flushing Patient presented today for second dose of COVID vaccine. She tolerated her first dose well. She has... Read more
Patient presented today for second dose of COVID vaccine. She tolerated her first dose well. She has h/o elevated BP and "flushed" feeling with various meds including once when she was doing a bowel prep for a colonoscopy. We decided to monitor her for 30 minutes and she felt fine throughout. As she was walking to her car she felt "flushed" and a bit light headed so she returned to the monitoring area. Initial BP was 189/77, pulse 110, O2 sat 100%. We brought her to the back room so she could sit in a recliner and remove her mask. Subsequent BP 186/77, pulse 86 then 184/69, pulse 80 about 20 minutes later. O2 sat remained upper 90s to 100%. She continued to report feeling "flushed" and noted pressure/pain behind her left eye so we elected to call EMS (and this was also patient request to go to the ED) so she could be evaluated. She drove herself to appointment. Her plan was to call her son to have him meet her at the ED. She left via ambulance in stable condition.
73 2021-03-01 flushing SOB, facial flushing, observed by EMS-cleared
73 2021-03-02 flushing Facial flushing in recovery area. no respiratory distress or itching. Pt given Benadryl 50 mg PO. VS... Read more
Facial flushing in recovery area. no respiratory distress or itching. Pt given Benadryl 50 mg PO. VSS. Patient refused transport to hospital. Husband was a previous EMS and wanted to take her home.
73 2021-03-02 tingling, weakness rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week fe... Read more
rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week feeling
73 2021-03-03 pain in extremity Around 3 PM on 3/2 arm was extremely sore and became worse as time progressed. By 6 PM developed... Read more
Around 3 PM on 3/2 arm was extremely sore and became worse as time progressed. By 6 PM developed aches, chills and low grade temperature. Became lightheaded. Could not sleep due to symptoms. No appetite but drank herbal tea and water with added electrolytes. That severity of symptoms lasted until 3/4 at 6 AM. Still am having some residual effects as one might have with the flu ? fatigue etc. Temperature is gone no more chills appetite still diminished.
73 2021-03-03 tenderness, pain in extremity Day of shot my left arm felt sore and also my left arm pit. By evening it was so sore it hurt to m... Read more
Day of shot my left arm felt sore and also my left arm pit. By evening it was so sore it hurt to move arm or touch arm pit. Morning after 1 PM second shot, my left eye was almost completely covered in blood. My arm pit also very sore and found a bruise on the side of my left breast and also on my left hip. I slept a lot and by the next day everything eased up. After another day my eye was clear and bruises fading. The last thing to go away was the soreness in my left arm pit.
73 2021-03-04 muscle spasms March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symp... Read more
March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symptoms that had been in remission were now present. no strength in left injection arm, all muscles weakened. slight headache. All subsided about ten pm.
73 2021-03-04 pain in extremity Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulde... Read more
Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulder, arm to palm, thumb and finger tips. Muscular pain from neck (felt like pinched nerve) thru shoulder to wrist (felt like carpel tunnel). Blooming painful pustule rash from shoulder to wrist on inner arm for one week. Post-herpetic and muscular pain continues through rash scabbing and drying, to date March 6, 2021. This is my second event in 37 years.
73 2021-03-05 bell's palsy I have developed bell's palsy. I am not sure if that is due to the Pfizer vaccine. Otherwise, I ... Read more
I have developed bell's palsy. I am not sure if that is due to the Pfizer vaccine. Otherwise, I am in excellent health.
73 2021-03-08 feeling hot Site is very itchy.; Arm red and hot; Arm red and hot; This is a spontaneous report from a contactab... Read more
Site is very itchy.; Arm red and hot; Arm red and hot; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 23Jan2021 at 11:30 AM (at the age of 73 years) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, asthma, hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine sodium, hydrochlorothiazide/losartan potassium. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Feb2021 at 16:00 PM, the patient experienced arm red and hot. On an unspecified date the patient experienced the injection site is very itchy. No treatment was given for the events. The clinical outcome of arm red and hot was not recovered. The clinical outcome of injection site is very itchy was unknown. . It was also reported that since the vaccination, the patient had not been tested for COVID-19.
73 2021-03-14 numbness L arm/hand numbness; blood pressure abnormality; chest pain; respiratory distress; This is a spontan... Read more
L arm/hand numbness; blood pressure abnormality; chest pain; respiratory distress; This is a spontaneous report from a non-contactable other-HCP. This other HCP reported for a 73-Years-Old (same age at vaccination) female patient that she received the first dose of bnt162b2 (BNT162B2, Lot number EN6205), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medication was none. She had not been back to her pcp for "several years". No known history of HTN. She did have a blood pressure cuff at home. During her 15-minute waiting period after the injection on an unspecified date, the patient began to experience L arm/hand numbness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, rapid progression of symptoms and respiratory distress. Treatment included: no therapy. Follow up response was excellent. Patient discharge: stable to go home and follow up with PCP. Outcome of events was unknown. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on the information provided, and on a close drug-event temporal association, the Company assessed there was a reasonable possibility that the reported serious events were related to the suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
73 2021-03-17 feeling hot could taste metal in my mouth; get over heated and breathing slightly difficult; get over heated and... Read more
could taste metal in my mouth; get over heated and breathing slightly difficult; get over heated and breathing slightly difficult; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: EL8982) via an unspecified route of administration at left arm on 16Feb2021 at 01:15 PM at a single dose for COVID-19 immunization. Medical history included allergies to medications, food, or other products: dairy and pineapple. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: EL8982) at left arm on 29Jan2021 at 01:15 PM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included acetylsalicylic acid (BABY ASPIRIN) and vitamin D nos. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. As soon as the nurse started to administer the shot the patient could taste metal in her mouth. Within minutes she started to get over heated and breathing slightly difficult. She opened all the windows in the car and reminded herself that she was breathing and could blow the horn at any time. Difficulty breathing lasted minutes but the overheating about 20 minutes. Once she cooled down all symptoms disappeared. Adverse event start date was reported as on 16Feb2021 at 01:15 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolved on 16Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
73 2021-03-22 tingling Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history signifi... Read more
Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history significant for hypertension, hyperlipidemia, hypothyroidism, and breast cancer. She presented to the emergency department with reports of possible allergic reaction to Pfizer vaccine. Patient received her first dose of: Vaccine earlier today and approximately 5 minutes later developed a cough, diaphoresis, and lightheadedness. She was given 50 mg oral Benadryl in the ED. Patient then complained of tingling sensation throughout her body and was continuously coughing. She was brought to the emergency department for evaluation. Patient noted she felt jittery and "disconnected". In the ED her cough and dizziness significantly improved. Upon examination, patient was noted to have right lower extremity weakness. She denied any weakness. CT of the head was performed to rule out stroke. Neurology was consulted. CT head brain was negative however patient was still having right-sided weakness. Emergency department physician confirmed the patient was able to get up without difficulty after receiving her vaccine at 1415 immediately following her vaccine. It was determined she was within the window for TPA. Patient was transferred to the ICU for further management.
73 2021-03-22 seizure, muscle twitching seizure; twitches jerks; This is a spontaneous report from a contactable consumer (patient) via Medi... Read more
seizure; twitches jerks; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW6205), via an unspecified route of administration on 25Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, diabetes, seizure disorder, and was put on continuous positive airway pressure (CPAP) machine. Concomitant medication included unspecified medication for high blood pressures. Patient stated that her blood pressures are normal but she was on medication for it. The patient previously took phenobarbital for seizure. The patient got the first dose of the vaccine on 25Feb2021 and later that day, the patient had a seizure and was in the hospital for days. The patient was put back on seizure medication, Keppra. It was further reported that patient was diagnosed with a seizures disorder when she was 20. She haven't had a seizure probably in 40 years and she was put on a CPAP Machine and she started getting good sleep and she was able to go off all seizure medicines about 10 years ago. The patient got the first shot on the 25Feb, she sit around for 15 minutes and no adverse reactions. She went to lunch with her sister and started having like what she call twitches jerks (not clarified) and she went home and little bit later that afternoon she had a major seizure and had to be taken to the hospital and there she stayed about 4 days. Now she was home and back on her seizure medication (further clarified as Keppra). The patient was hospitalized for seizures on 25Feb2021 and was discharged March 1st or 2nd. Additionally, it was reported that patient had a bunch of laboratory test (unknown results) in the hospital. Electroencephalogram (EEG) and magnetic resonance imaging (MRI) were performed with unknown results. Therapeutic measures were taken as a result of seizure which included Keppra. The outcome of the events was unknown.
73 2021-03-24 seizure, inability to speak, facial paralysis Seizure, aphasia, facial droop 3 days after receiving vaccination.
73 2021-03-26 weakness, tremor Heart Attack: taken by ambulance to hospital ER: symptoms were weakness, pounding, racing heart, un... Read more
Heart Attack: taken by ambulance to hospital ER: symptoms were weakness, pounding, racing heart, uncontrollable shaking
73 2021-03-28 weakness Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high bl... Read more
Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high blood pressure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 02Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included hypertension and PCN allergies (penicillin allergy). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccine in four weeks. Concomitant medication included unspecified medication. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on Jan2021 15:15 as a single dose for covid-19 immunization. On 25Feb2021 06:00 PM, the patient was very tired, low energy (it has been almost 3 weeks), had one fainting episode though the patient doesn't know if it was related, and problems with high blood pressure. The fainting episode is reported, the other problems have been ongoing since second shot. The events required emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure was high on 25Feb2021 and nasal swab (sars-cov-2 test) was negative on 22Feb2021. The outcome of the events was recovering. Information on the lot/batch number for first dose has been requested.
73 2021-03-30 bell's palsy Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-ye... Read more
Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 11:30 (Batch/Lot Number: EN6199) as single dose for covid-19 immunisation. Medical history included diabetic, arthritis, torn right shoulder, neuropathy plantar fasciitis arthritis back pain, allergies: sulfa, antibiotics, indomethacin, amoxicllin, sulfacetamide. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for an unspecified indication from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for an unspecified indication from an unspecified start date and ongoing; fluoxetine (FLUOXETINE) taken for an unspecified indication from an unspecified start date and ongoing; diclofenac (DICLOFENAC) taken for an unspecified indication from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for an unspecified indication from an unspecified start date and ongoing; metformin (METFORMIN) taken for an unspecified indication from an unspecified start date and ongoing; pregabalin (PREGABALIN) taken for an unspecified indication from an unspecified start date and ongoing; simvastatin (SIMVASTATIN) taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication from an unspecified start date and ongoing; amitriptyline (AMITRIPTYLINE) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced bells palsy on 12Mar2021 with outcome of not recovered, runny nose on 12Mar2021 with outcome of recovering. Clinical course: the consumer said that the Bell's palsy started Friday with a runny nose, her right side nostril. She said Saturday she had it where she can't move the right side of her face properly, and that is when she called to make her doctor's appointment for this morning. The reported events required visit to: Physician office. The patient received prednisone 1 daily for 7 days as treatment for the event Bells Palsy.
73 2021-04-01 facial paralysis, speech disorder, tremor Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in ri... Read more
Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in right eye/ Occasional shooting pain in eye; Eyes watering; Groggy; Dizzy; Extreme fatigue; Brain foggy; Forgetful; Sleep cycle distorted; Essential tremors in hands; Dull pain in back of head near neck; slightly garbled/ voice difficult to understand; Sensitive to loud noises; This is a spontaneous report from a contactable Other-HCP (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 01Mar2021 16:30 (Batch/Lot Number: en6198; Expiration Date: 01Mar2021) as single dose for covid-19 immunisation. Medical history included COPD. Concomitant medication included salbutamol (VENTOLIN [SALBUTAMOL]);and fluticasone propionate/ salmeterol xinafoate (ADVAIR). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: em9809) on 07Feb2021 04:00 PM, in left arm for covid-19 immunisation at age of 73 years old. The patient experienced eyesight was dimmed, even when she can manage to open her eyelids, occasional shooting pain in eye, eyes watering, throbbing pain mostly in right eye, Bell's Palsy partial facial paralysis on both sides: can't smile, voice difficult to understand, slightly garbled, groggy, dizzy, brain foggy, forgetful, extreme fatigue, sensitive to loud noises like dog's bark, sleep cycle distorted, essential tremors in hands are greater than usual, and dull pain in back of head near neck and all on 02Mar2021 05:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient is not pregnant. The treatment was received. No covid prior vaccination and no covid tested post vaccination. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown result on unspecified date. The outcomes of events were recovering.; Sender's Comments: Based on a plausible temporal association, the company cannot completely rule out a causative role of BNT162B2 to the onset of facial paralysis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
73 2021-04-02 pain in extremity Two blood clots in my right calf that travelled up to my lungs; Shortness of breath; Pain in my righ... Read more
Two blood clots in my right calf that travelled up to my lungs; Shortness of breath; Pain in my right calf; Had difficulty just walking; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in left arm on 12Feb2021 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included heart (as reported) and known allergies to penicillin. There concomitant medications were not reported. On 15Feb2021 18:30 the patient experienced two blood clots in my right calf that travelled up to my lungs, shortness of breath, pain in my right calf, had difficulty just walking. It was reported that two nights after receiving the vaccine, she suffered shortness of breath and pain in her right calf. She tried to relax the next day, but had difficulty just walking. She went to a walk in medical facility. They sent her to the ER. After testing they found that she had two blood clots in her right calf that travelled up to my lungs. The event two blood clots in my right calf that travelled up to my lungs was considered as serious (hospitalization) and other event were considered as serious (hospitalization). The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included blood test on 15Feb2021 with showed two blood clots in my right calf that travelled up to my lungs and sars-cov-2 test with negative results on Feb2021.Therapeutic measures were taken as a result of two blood clots in my right calf that travelled up to my lungs, shortness of breath, pain in my right calf and had difficulty just walking. AE treatment included blood thinner. The outcome of the events was recovering. No other vaccine was given to patient in four weeks and two weeks. No Covid prior vaccination. If Covid tested post vaccination: Yes. Patient was covid tested post vaccination in Feb2021 with negative results. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Facility type vaccine was Public Health Clinic facility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
73 2021-04-09 pain in extremity pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoul... Read more
pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoulder; pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm; tooth ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6198, via an unspecified route of administration administered in right arm (shoulder) on 03Mar2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure abnormal, thyroid problems, fall (fell a couple of years ago), and trouble with her shoulder (prior to getting the vaccine). She reported that she did have some trouble with her shoulder prior to getting the vaccine. She fell a couple of years ago and the doctor's x-rayed it and thought it was pulling away from the bone. They didn't have to do surgery. She was completely over that and it had resolved before getting the vaccine. Patient has no additional vaccines administered on same date of the Pfizer suspect. Patient has no prior vaccinations within 4 weeks. Concomitant medications included metformin hydrochloride, sitagliptin (JANUMET) taken for diabetes from an unspecified start date and ongoing (been taking it a long time over 20 years); glipizide taken for diabetes, start and stop date were not reported (been taking it a long time over 20 years); losartan taken for blood pressure from an unspecified start date and ongoing (been on it about 10 years, her blood pressure is in between and it doesn't bother her a lot, it is not really high or low); and thiamazole (METHIMAZOLE) taken for thyroid problem from an unspecified start date and ongoing (been on it about ten years). Patient was calling because she had her first Pfizer shot about three weeks ago. About three days after on 06Mar2021, she developed pain in the right shoulder where she got the shot. It has been bothering her up until this time. She also had a pain over her heart area. The pain over her heart area occurred when she was breathing it. That has gone away. She had her second shot today and she was trying to explain to the doctor what happen to the right shoulder. He said the shot had to be in the other shoulder and he put it in the left shoulder in the bone. It hit the bone. She hollered because it hurt so bad. He said no one ever jumped like that before. She jumped because it hurt. She still has the pain in the right shoulder, but she doesn't feel anything in the left where she got it today. She clarified Pfizer shot as COVID19 vaccine. The pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm in Mar2021. She got first and second dose. She got the first dose of COVID19 vaccine on 03Mar2021. Pain in the right shoulder: it felt like her toothache has something to do with the pain in the shoulder. The toothache came on a little later (Mar2021) than the pain in the shoulder. The tooth ache is still ongoing, but it has improved. Pain over heart area: It started at the same time as with the pain in the right shoulder. The pain over the heart stopped about a week ago. She thinks she has recovered completely. She didn't have anything done for the heart pain. She got the second dose today, 25Mar2021, lot number: ER8733, Expiry date: unknown. The outcome of the events 'pain over her heart area and pain in the right shoulder travels down the right arm/it goes down the shoulder and down the arm' was recovered, event tooth ache was recovering, and events 'pain in the right shoulder where she got the shot (vaccination site pain) and pain in the right shoulder' was not recovered.
73 2021-04-11 weakness increasing body wide weakness 1 day after vaccine, found to be in fulminant renal and hepatic failur... Read more
increasing body wide weakness 1 day after vaccine, found to be in fulminant renal and hepatic failure with +troponin and rhabdomyolysis with no other preceding symptoms or significant history
73 2021-04-12 breast pain 3 bouts of ulcerative colitis; her B12 was over 2000; copper was 189.2; Folate 16.8; foamy spit; dry... Read more
3 bouts of ulcerative colitis; her B12 was over 2000; copper was 189.2; Folate 16.8; foamy spit; dry mouth; Breast pain in the right side; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Solution for injection, Lot number: unknown), via an unspecified route of administration in right shoulder muscle on 05Mar2021 at the age of 73 years old as SINGLE DOSE for COVID-19 immunization. Patient medical history included Hypothyroidism and high blood pressure. Concomitant medications included levothyroxine sodium (SYNTHRIOD), one half of 25 mcg tablet, once a day, taking the medication many years, it's been like 5 years for Hypothyroidism and hydrochlorothiazide 25mg 1 tablet daily for High blood pressure. On 18Mar2021, she had 3 bouts of ulcerative colitis, foamy spit, dry mouth, breast pain in the right side where she got first dose. The patient reported that, she had the Covid vaccine in March of 5th, she has some lab test drawn on 18th and copper level was extremely high and folate level was high too, plus she has been having Phony stiff in my mouth. It was also reported that, her B12 was high also it never been so high it never been 2000 and I haven't been taking b12 from quite a while, she wonders if this was shot related, had dry month and besides that she had three bout of colitis, ulcerative colitis attacks. The colitis, it started than and went through 24th about had 3 bouts of it 3 different days of terrible pain, started probably the 20th. It was also reported that, she is not eating a lot and not taking any supplements, her doctor told her to stop everything so that's what she did, usually she takes supplement. She said she is hesitant about taking the second dose. Caller wanted to know does the vaccine have copper in it and response. The patient supposed to get her 2nd one on Friday. On 18Mar2021, the patient had performed with lab tests and which included vitamin B12: 2000 pg/mL; Copper: 189.2 ug/dL and folate: 16.8 ng/mL. The patient did not take any treatment for events. There was no PQC involved. The outcome of the events was not recovered. Information on Lot/Batch number was requested. cannot be obtained.
73 2021-04-17 migraine Could understand words but could not answer back; Her symptoms came out as if she was having a strok... Read more
Could understand words but could not answer back; Her symptoms came out as if she was having a stroke.; Bad headache/migraine; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6207, expiry date: Jul2021), via an unspecified route of administration, administered in left arm on 19Mar2021 10:45 at single dose for COVID-19 immunization. The patient's medical history included diabetes from Jun2001 and ongoing. The patient's concomitant medication included metformin taken for diabetes from Jun2001 and ongoing. The patient previously received flu shot from immunization (she had the flu shot 20 years ago had bad reaction to). Facility where the most recent COVID-19 vaccine was administered was at the hospital. The vaccine was not administered at military facility. The patient received the vaccine on 19Mar2021 and she felt fine that Friday. On 20Mar2021 (Saturday), she started having a bad headache and took Aleve. She took Aleve 3 times 4 hours apart because she still had a bad headache. She started losing the ability to bring out words. She stated that her headache was gone. On 21Mar2021 (around 4 o clock), her husband was in the kitchen and asked her a question but could not understand her and asked again. She could not say the words but she could spell them. Her husband asked her another question, she tried to talk but she could not answer back. At that point her husband said they were going to the hospital. She was admitted for 3 days from 21Mar2021 to 23Mar2021. The doctor told her she was having a migraine because it had lasted for 2 days. She also spoke with her primary care provider, who looked it up and said this could be a side effect. She was told the migraine may take away the ability to talk. Her headache has been gone but continues to feel very tired (extremely tired since 19Mar2021). Her symptoms came out as if she was having a stroke on an unspecified date. The event 'could not understand words but could not answer back' required an emergency room visit.The patient underwent lab tests and procedures which included CAT scan, MRI, and contrast test, all with negative result on 22Mar2021. The outcome of the event 'could understand words but could not answer back' was recovered on 22Mar2021, the event 'bad headache/migraine' was recovered on 21Mar2021, not recovered for extremely tired, and unknown for the event 'stroke'.
73 2021-04-18 muscle spasms wiped herself there was blood on the toilet paper and "quite a bit in my pajamas".; cramps; distress... Read more
wiped herself there was blood on the toilet paper and "quite a bit in my pajamas".; cramps; distressed; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8730 and expiration date Jul2021) via unknown route on 01Apr2021at 16:00 at single dose for COVID-19 immunisation. Patient reported that she was allergic to bee stings so her doctor told her she should wait 30 minutes after getting the vaccine to observe for any reaction instead of the 15 minutes. The patient concomitant medications were Zydus, USP 75 mg Venlafaxine HCl (EFFEXOR XR). Patient was fine and left, when she got to her car she took 2 Tylenol and went to the grocery store and did some errands. 4 hours later, patient took 2 more Tylenol. Patient reported that this morning (02Apr2021) she got up from bed to go to the bathroom and noticed that when she wiped herself there was blood on the toilet paper and "quite a bit in my pajamas". Patient reported she was experiencing cramps. Patient believes she's having her period. Patient sounded distressed, reported that she hasn't had a period in years and now she is anxious and scared. Is really scared and wanted so seek medical advice. Unable to contact personal doctor, Declined ISI, cold transferred to PMI due to hold time. Will fax AE for side effects. Patient reported that yesterday she also started a new dose of her Effexor which was increased from 37mg to 75mg which she takes for anxiety and depression, she took the first increased dose yesterday evening and doesn't know if that is what caused this or the Covid shot. Her second dose is scheduled for 29Apr2021. Patient reported that she called her General Practitioner who was not in the office today and her GYN who hasn't yet called her back but she reports that the nurse instructed her to go to the walk in clinic for evaluation, but the caller reports she don't want to go because of the Covid. She spoke with someone before speaking to this agent saying they read her a bunch of information but it was not clear if she spoke with safety or customer service. Obtained the lot number for her first vaccine dose with exp. Patient stated 'I'm a nervous wreck" asking, if the symptom she was experiencing is from her Covid vaccine. Patient asked if her second shot supposed to be more than 21 days from the first. The case was reported as non-serious. Upon callback, she stated she has had a really bad day and spent all afternoon at the walk in clinic. She found out her symptoms were not related to the vaccine and said she could not talk anymore because she was driving. Callback made but caller said she could not talk and did not request a callback. The outcome of the events was unknown. Additional Information is requested.
73 2021-04-24 pain in extremity Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mou... Read more
Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Face felt tight, first vaccine.; Mouth and nose dry, first vaccine.; Mouth and nose dry, first vaccine.; Sore arm, first vaccine.; This is a spontaneous report received from a contactable consumer(patient). A 73-year-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 73-years-old, via an unspecified route of administration, administered in Arm Left (in the back of the arm) on 20Jan2021 (maybe at 11:10 am) (Lot Number: EL3246; Expiration Date: Apr2021) as single dose for covid-19 immunisation. Medical history included ongoing Postural vertigo maybe 10 years ago for a day. No family medical history relevant to AE. The patient's concomitant medications were not reported. Patient got the Shingles vaccine years ago and the next day, she had a sore arm and tingles, up and down her arm. She didn't feel food for 7 days and felt achy. It was the first Shingles shot. No prior Vaccinations (within 4 weeks). The patient experienced blood and clots came out of nose and mouth on 21Jan2021 (the same time that she woke up) with outcome of recovered on 21Jan2021. She blew her nose and leaned over and noticed a drop of blood on the rug and grabbed a Kleenex. She blew her nose, easy, and all of a sudden blood and clots came out of her nose and mouth. It lasted for about 8 minutes. Sore arm on 20Jan2021 (started in the evening) with outcome of recovered on 21Jan2021. Face felt tight on 21Jan2021 (around 8:30 or 9:00 am) with outcome of recovered on 21Jan2021. Mouth and nose dry on 21Jan2021 (in the morning) with outcome of recovered on 21Jan2021.
73 2021-04-24 weakness Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; ... Read more
Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 09Mar2021 12:00 (received at the age of 73-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included asthenia and known allergies to Sulfa drugs, NSAIDS. The patient was not pregnant. She did not have covid prior vaccination. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; and vitamins. The patient experienced extreme fatigue (fatigue) (disability, life threatening), decreased energy (asthenia) (disability, life threatening), needed to sleep most of the day (hypersomnia) (disability, life threatening), difficulty maintaining balance (balance disorder) (disability, life threatening), heart palpitations (palpitations) (disability, life threatening), all on 11Mar2021 04:00. These conditions started 2-3 days after the first vaccine (as reported). The adverse events resulted in Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient did not receive any treatment for the adverse events. Outcome of the events was recovered on an unspecified date in 2021. The patient was not tested for covid post vaccination.
73 2021-04-27 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration (injection), administered in the right arm on 12Feb2021 at 13:00 (batch/lot number: EL9267) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from 1991 and ongoing (diagnosed 30 years ago; doctor said that he didn't know if she has RA because she's taken all of those infusions and it may just be severe osteoarthritis), ongoing thyroid (disorder), thyroid was removed, knee replacement left leg from 2020 (she had knee replacement last year on her left knee), Achilles tendon tear - reported that she had to have surgery last to repair her right Achilles tendon as it tore, cholesterol (abnormal) from 1991 and ongoing (diagnosed with cholesterol problems 30 years ago), ongoing depression (diagnosed with depression a couple years ago), ongoing sleep problems (experienced sleep problems for a long time), blood pressure (abnormal) from 2013 and ongoing (diagnosed with blood pressure problems 8 years ago), physical therapy, lymphedema, and unable to recall exact dates. There was no family medical history. No prior vaccinations (within 4 weeks). Concomitant medications included amitriptyline taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); folic acid taken for arthritis from an unspecified start date and ongoing (she has been taking this medication for years and years); levothyroxine taken for thyroid, start and stop date were not reported (she has been taking this medication for years and years); chlordiazepoxide (LIBRIUM) taken for sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); losartan taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); meloxicam taken for arthritis from an unspecified start date and ongoing (began taking for 10 or 15 years after switching from celecoxib); metoprolol taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); omeprazole taken for stomach from an unspecified start date and ongoing (helps her stomach with all of the medications she has to take); pravastatin taken for cholesterol from an unspecified start date and ongoing (she has been taking this medication for years and years); desvenlafaxine succinate (PRISTIQ) taken for depression from an unspecified start date and ongoing (she started taking over a year ago, a year and a half or maybe two years ago); levothyroxine sodium (SYNTHROID) taken since thyroid was removed from an unspecified start date and ongoing (she has been taking since 15 years ago, for a long time); temazepam taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); cholecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date and ongoing (she has been taking this medication for years and years). The patient previously took BNT162B2 first dose on 21Jan2021 via injection in the right arm (lot number: EL3047 or EL3247; expiration date unknown) for COVID-19 immunization; and celecoxib (CELEBREX). The patient experienced extensive deep vein thrombosis on 06Apr2021; leg pain and feet swollen/ leg was like a balloon/ leg started to swell on 05Apr2021; throat hurts and tired on an unspecified date. The patient was calling about the Pfizer Covid-19 vaccine. She reported that she and her husband received both doses of the Pfizer Covid-19 vaccine. She received her first dose of the Covid-19 vaccine on 21Jan2021 and her second dose on 12Feb2021. She reported that she has had no complications before such as blood clots or problems with her blood or anything. She reported that on Monday, 05Apr2021, her leg started to swell. She reported that on the following day, 06Apr2021, her leg was so swollen that she couldn't put it down. She reported that she went to the emergency room on 06Apr2021 and was found to have an extremely extensive deep vein thrombosis. She reported that she was calling to complete a safety report. She stated that she doesn't want a deep vein thrombosis to happen to anyone else if her thrombus was from the Covid-19 vaccine. She reported that she and her husband thought they were so lucky as they had no side effects whatsoever following the Covid-19 vaccine doses. She reported that she was not saying that the deep vein thrombosis was from the Covid-19 vaccine but she has never had any blood or clotting problems in her life. Throat hurts: She reported that she thinks that when she was intubated, that whoever intubated her caught her tongue and cut it. She reported that she and her son and husband had been seeing news stories about the (Company name) vaccine. She reported that she has friends that were waiting for the (Company name) vaccine. She reported that her son wanted to send a text message so that others could be aware of the problems they might have. Leg pain: She reported that she went to the dentist on 05Apr2021 and was fine. She reported that when she got home from the dentist, her husband asked if she wanted to the take dog for walk. She reported that she put a leash on her dog and walked to the end of her driveway and said to her husband that she couldn't walk because her leg hurt so much. She reported that she had 2 surgeries last year, a knee replacement in her left leg and an Achilles tendon repair in her right leg. She reported that when she was released from physical therapy that the therapist told the caller that she might have lymphedema. She reported that the physical therapist directed her to go to a clinic that had no doctor where the clinic staff wanted her to buy a (dollar)10,000 piece of equipment to pump up her legs in the morning and at night. She reported that she came home from the clinic and called the podiatrist that repaired her Achilles tendon. She reported that she went to see the podiatrist that day and that the podiatrist ordered an ultrasound. She reported that a vascular surgeon called her regarding the ultrasound and stated that there was nothing wrong with the veins in her legs. She reported that the surgeon stated that they could tell there was nothing wrong with the her because her feet weren't swollen and instructed her to follow up in 9 months. She reported that on 05Apr2021, she went back into her house after experiencing the leg pain. She reported that her feet were not swollen and she was not that concerned. She reported that she thought maybe she was just tired and laid down. She reported that when she woke up the next morning, 06Apr2021, that her feet were like balloons. She reported that her son called a friend of his who was an orthopod. She reported that her son's friend instructed her son to take her to the emergency room, recommending that they bypass a certain hospital. She reported that she went to the emergency room on 06Apr2021. She reported that the emergency room staff did an ultrasound as soon as the caller arrived. She reported that the emergency room staff called the vascular surgeon. She reported that the vascular surgeon stated that if he had been in the caller's hospital room 5 minutes earlier that the would have done the surgery then, but that he had to lay her on her stomach to perform the surgery and she had eaten some cookies and drank diet soda. She reported that on the following day, 07Apr2021, the vascular surgeon put a scope in her vein and pulled out the clot. She reported that the physician was extremely concerned because the clots were very extensive. Leg pain: She reported that the leg pain was still ongoing. She reported that it hurts when she walks. She reported that she doesn't know if the leg pain has gotten worse. She reported that her leg pain on 06Apr2021 was excruciating and off the charts. Feet swollen: She reported that the swelling in her feet has maybe gotten slightly better. She reported that her feet were wrapped tightly with ace bandages. Leg swollen like a balloon: She reported that her leg was still swollen but it's gotten better, maybe about 90%. Extensive deep vein thrombosis: She reported that the deep vein thrombosis was removed on 07Apr2021 from her left leg. She reported that she was at end of her life and she had trips planned. She reported that she had a trip planned recently to go to Las Vegas with her daughter. She reported that her daughter was not able to take the trip, and stated she didn't know what would have happened if she had experienced the blood clot while in Las Vegas. She reported that she received both doses of the Covid-19 vaccine in her right arm, as she was in the car and her husband was driving. First dose: Date: 21Jan2021; Lot Number: She reported the lot number as EL3047, then stated that the handwriting was hard to read and that the lot number was either EL3247 or EL3047. She stated when reporting on her history that she has no concept of time and was unable to recall exact dates. She reported that while in the emergency room and during admission, the hospital staff did labs, but she has no idea what the results were. Vaccination facility type was drive through clinic at (clinic name). Vaccine administered at military facility: No. The adverse events leg pain, swelling in feet and leg, extensive deep vein thrombosis required a visit to the emergency room. Did not require a visit to the physician's office. The patient was hospitalized for 6 days for extensive deep vein thrombosis from 06Apr2021 to 12Apr2021. The patient underwent lab tests and procedures which included CT scan of chest: normal on an unspecified date, ultrasound: there was nothing wrong with the veins in her legs on an unspecified date, ultrasound: unknown results on an unspecified date. The outcome was not recovered for the event leg pain; recovering for the event feet swollen/ leg was like a balloon/ leg started to swell; and unknown for the rest of the events.; Sender's Comments: Reported events are assessed as intercurrent medical conditions probably associated to patients underlying conditions and are therefore unlikely related to BNT162B2.
73 2021-04-27 burning sensation, pain in extremity she have her arm completely swollen to the elbow and it is red with a circle around the injection si... Read more
she have her arm completely swollen to the elbow and it is red with a circle around the injection site. She says that she even developed cellulitis; Still having problems with left arm it still burns, itches, and still has a throbbing pain; Still having problems with left arm it still burns, itches, and still has a throbbing pain; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number), via an unspecified route of administration, on 09Apr2021 (at the age of 73 years-old) as a single dose for COVID-19 immunization. Historical vaccine information included bnt162b2 (COMIRNATY), 1st dose on an unspecified date and no adverse reaction. The medical history included: acid reflux. Concomitant medications were not reported. She says that she is a healthy person and does exercise, has no weight problems, nothing but acid reflux. The patient reported that she got the second on Friday at 1 pm and now she have her arm completely swollen to the elbow and it is red with a circle around the injection site. She says that she even developed cellulitis and she is not happy about this. Her left arm was on fire, burned, very swollen from the site all the way down to the elbow. That went away, the swelling finally started to go down Tuesday of last week but she is still having problems with left arm it still burns, itches, and still has a throbbing pain. She has been in the ER twice already and they told her that if the circle around the injection site gets bigger she would need an IV. She has been to the ER 3 days later twice at two different locations. Caller states she is still having difficulty after getting her second Pfizer shot. She contacted her doctor to let them know because she wants them to document everything. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
73 2021-04-28 pain in extremity, cold sweat didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; ... Read more
didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; blood pressure 82/50; skin tenting; dizziness/orthostatic dizziness/dizzy; Nausea vomiting; Nausea vomiting; chills and cold sweats; chills and cold sweats/all sweaty, cold; felt blah; sore arm after 2nd dose; This is a spontaneous report from a contactable nurse reporting for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received BNT162B2 on 16Mar2021 (at the age of 73-years-old) for COVID-19 immunisation and experienced Sore arm and feeling blah. Clinical course was as follows: She spent 50 years in neurology and neuroscience, she was a crazy RN that did neurology right out of school, she was recommended for that specialty. She is not sure if she had a reaction to the vaccine or if it is just her. Her 2nd dose was last Wednesday, 07Apr2021. She had a sore arm and felt blah. Just like after the 1st shot. On Saturday night (10Apr2021) at 0200, she was awakened with chills, cold sweat, dizziness, nausea and vomiting. She was sick as a dog for 2 days and didn't eat or drink much of anything. She went to the doctor who sent her to an infusion center. She is down to 5' 2" and weighed too much. She has not been able to lose weight for a couple years. She gained 40 pounds when she turned 50 years old. After the shot, she had a sore arm and felt blah like she did after the first dose, but she thought everyone felt that way. She missed a day of gym class because of her really sore arm. This got better like after a flu shot, it was nothing. This time she had a really sore arm and felt blah after the shot but then on Saturday morning this whole thing started happening. She woke up very restless, was all sweaty, cold, dizzy and was too miserable to try and take her blood pressure. Her blood pressure tends to run low. Her symptoms of the sore arm resolved at 06:00 Saturday (08Apr2021). She had nausea and vomiting and couldn't eat or drink. That lasted through Monday morning. She had some back pain with this, but she has back pain normally as she is a little old lady. She had a scheduled Oncology appointment Monday, as did her husband. She experienced orthostatic dizziness. She woke up plain dizzy. Her doctor gave her a liter of fluids and it helped her. This was something that needed to be addressed. It was serious. It was all serious. She had nothing left to vomit. She is an old lady with Breast Cancer. Her creatinine level of 1.10 which dropped her GFR of 52, she calculated the GFR using a computer program. This is what lead to the doctor giving her a liter of fluid. She had an appointment scheduled and her doctor sent her to the infusion centers for a liter of D5NS. She was sent home afterwards and encouraged to drink fluids. She also had a CBC and chemistry panel with her blood work. She was worried because her skin was tenting badly, and she couldn't keep anything down. She was probably dehydrated. Her blood pressure at the doctor's office was 82/50. She didn't care that her skin was tenting. She has been drinking a lot of fluids as advised after her liter of fluids at the infusion center. She is interested in researching the MRNA process because it is used it in other things. The way the vaccine was developed, it should have dissipated after 48 hours. She likes to research everything. She and her husband experienced a year from Hell starting in August of last year. All events are considered serious. The patient underwent lab tests and procedures which included blood creatinine: 1.10 and blood pressure measurement: 82/50 on 12Apr2021, blood test, full blood count and investigation with unknown results and glomerular filtration rate: 52 on an unspecified date. The outcome of the events chills and cold sweat was recovered on 12Apr2021, skin tenting and orthostatic dizziness was recovered on 13Apr2021, vomiting and nausea was recovered on 14Apr2021, pain in arm was recovered on 10Apr2021, feeling abnormal was recovered on an unspecified date, while of the rest was unknown.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
74 2021-01-05 pain in extremity Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptom... Read more
Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptoms started about 3:30pm and lasted from 6-8 hrs. Headache & sore arm lingering on 1/6/21.
74 2021-01-11 pain in extremity Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable cons... Read more
Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO142), via an unspecified route of administration in left arm, on 04Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history included arrhythmia, right shoulder reverse replacement, and fusion at L5S4. The patient's concomitant medications included metoprolol tartrate, digoxin, levothyroxine, and montelukast sodium (MONTEL). The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 04Jan2021 at 3:30 PM, the patient experienced headache, sore arm, vomiting, diarrhea, and chills. The events were considered non-serious. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.
74 2021-01-12 pain in extremity Received COVID vaccination on 01/06/2021 at 8:00 at the COVID vaccinations clinic. About 2:20pm emp... Read more
Received COVID vaccination on 01/06/2021 at 8:00 at the COVID vaccinations clinic. About 2:20pm employee states that Left arm started aching. Around midnight, employee states that right elbow began to ache as noticed redness and swelling approximately 2-3 inches below injection site. States swelling and redness increased over the course of two days. Friday, the swelling and redness began to improve.
74 2021-01-12 flushing felt flush. Symptoms resolved prior to leaving facility
74 2021-01-13 weakness very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site;... Read more
very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3246, expiry date not reported), intramuscular on 05Jan2021 13:30 at a single dose in the upper left arm for COVID-19 prophylaxis. There were no medical history and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient asked if there was any contraindication to getting the second dose. Patient reported having vomiting and shivers the day after receiving the vaccine as well as pain at injection site which was reportedly now resolved. Patient was calling about the Covid-19 vaccine and reported that she received the vaccine this past Tuesday 05Jan2021. She said that she was very sick the next day (06Jan2021). She said that 5 people went with her to get the vaccine and she was the only one who had gotten sick. Patient clarified that she had vomiting throughout the day the next day after receiving the vaccine. She also reported that she had shivers for hours and hours. She said that she had blankets and quilts on her and she could not stop shivering. She said that when she went to the doctor, the doctor thought it was because of the vaccine. Patient wanted to know if she should she take the second shot and if these will happen to her again or not and asked if there are any contraindications. She said that the vomiting started in the morning around 10:00 on 06Jan2021. It lasted a couple of hours until about 13:00 06Jan2021. She said that the shivers were bad, and she had big time shivering and there was nothing she could do to stop the shivering. The shivering lasted from 10:00 06Jan2021 until about 5-6 in the evening 06Jan2021. As the day progressed the pain where they gave her the shot was very bad on 05Jan2021. She said that she had pain at the injection site (pain injection site) on 05Jan2021. She said that it only hurts now if she touches the area. She said that the site previously it hurt without touching it. Patient was very weak and sleepy the next day. She said that she felt very weak and sleepy on 07Jan2021. She said that it lasted throughout the entirety of the day and she fell asleep and felt better today (at the time of the report). She said that today she felt fine. The events did not require emergency room visit but events required physician's office visit. The events were reported as not serious. Therapeutic measures were taken as a result of the events weak and sleepy. The patient recovered from vomiting on 06Jan2021 13:00, from shivers on 06Jan2021, from weak and sleepy on 07Jan2021. The patient was recovering from pain injection site. The outcome of the event sick was unknown.
74 2021-01-14 pain in extremity, feeling of body temperature change fevers of 101; getting worse; she is so sick; felt 'nausea, chilly and hot'/she is feeling hot; fel... Read more
fevers of 101; getting worse; she is so sick; felt 'nausea, chilly and hot'/she is feeling hot; felt 'nausea, chilly and hot'/nauseous; arm been sore; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 09:30 at single dose for prevention. Medical history included covid-19 from Jul2020, hair loss. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fevers of 101 on an unspecified date with outcome of unknown, felt 'nausea, chilly and hot'/nauseous on 08Jan2021 with outcome of not recovered, felt 'nausea, chilly and hot'/she was feeling hot on 08Jan2021 13:00 with outcome of not recovered, getting worse on an unspecified date with outcome of unknown, arm been sore on 06Jan2021 08:00 and on 08Jan2021 08:00 with outcome of not recovered, she was so sick on an unspecified date with outcome of unknown. Clinical course: She had it on Tuesday and arm been sore since then. now she gotten very nauseous. Her temperature is around 98 degrees Fahrenheit now and she is feeling hot. She does not have a temperature. After transfer caller stated ' I felt nauseous but now its gone, but also getting worse.' She was usually 96 or 97 degrees Fahrenheit. She was nauseous. Is this normal after 4 days. There was no prescriber. She was more sore on Wednesday than she is now. It is better yesterday and now than on Wednesday when it was real sore. She did something she should not have done. She went to a yoga class and had not eaten. Afterwards, she had a strawberry and did not feel like eating. Then she said she did not take her pills, which are mostly vitamins. The thought of taking pills made her sick. After she took them she ate something and has been nauseous ever since. She did not confirm if she needed glasses prior to getting the vaccine. She had COVID in Jul2020. She is taking a lot of vitamins. She had hair loss and is taking Biotin. She takes very few prescribed medications. Now she was so sick she would not think of taking them. No further details provided. The patient underwent lab tests and procedures which included body temperature: 98 degrees fahrenheit on unknown date. Information on the Lot/batch number has been requested.
74 2021-01-15 pain in extremity Sore arm that day (1/14) which is normal. Brain fog the following morning for 4 to 6 hours.
74 2021-01-20 bell's palsy Bells Palsy
74 2021-01-20 bell's palsy Bells Palsy diagnosed by ER 1-15-2021. treated with Prednisone and Acyclovir.
74 2021-01-20 feeling cold Got shot at 12:45 pm and at 6 pm the night I started feeling a little cold and by 7 pm I was really ... Read more
Got shot at 12:45 pm and at 6 pm the night I started feeling a little cold and by 7 pm I was really cold with chills and a headache. It lasted 24 hours.
74 2021-01-21 burning sensation As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my... Read more
As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my body was on fire. Also add headache could not hardly stand to lay my head on the pillow. About 4 AM I could not tolerate the situation any longer and took 600 mg of Tylenol. After that was able to rest some. The next day after the vaccination my joints were achy moderately and I have a headache. The injection site was tender to the touch and arm range of motion decreased and arm sore. Took 400 ibuprofen about 4 PM day after injection to ease Reactions
74 2021-01-23 pain in extremity On 1/20/21 I had the 1st Covid 19 vaccine in my left arm at 1:10pm and at exactly 9:00pm that evenin... Read more
On 1/20/21 I had the 1st Covid 19 vaccine in my left arm at 1:10pm and at exactly 9:00pm that evening I experienced a pain on my right side that went along the outside starting at the base of my little toe and continuing to the heel of my foot and from there going right on up the outside of my right leg to the base of my hip. At this point I laid down which made the pain a little better. I tried rubbing the area but that didn"t help much. I did take one advil an hour before bedtime but the moderate pain stayed the same. At midnight I went to bed and was able to sleep. By morning I was fine.
74 2021-01-23 pain in extremity, discomfort Starting about 11PM, left arm from fingers up my arm to below my ear, across to my right shoulder ac... Read more
Starting about 11PM, left arm from fingers up my arm to below my ear, across to my right shoulder ached, had chills, and could not get comfortable in bed. Once up at 7 AM took two Advil 200mg with relief
74 2021-01-24 tremor Approximately 10-15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. BP:... Read more
Approximately 10-15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. BP: 160/60, HR: 70, RR: 24-28, O2 sats: 98%. No other symptoms noted. Pt. assessed local EMS. Declines going to emergency room today. Pt. plans to go to urgent care or call PCP.
74 2021-01-24 tremor Approximately 15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. Pt. wa... Read more
Approximately 15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. Pt. was immediately assessed by Physician. Also assessed by local EMS. BP: 160/60, HR: 70, RR: 24-28, O2 sates: 98%. Pt. declines to be transported to the emergency room. Plans to make appt. with PCP.
74 2021-01-24 pain in extremity, facial pain, weakness Developed hives on my face, on my head, on top of my back and they also itch in addition to the all ... Read more
Developed hives on my face, on my head, on top of my back and they also itch in addition to the all over itching; headaches; Pain around my face, my left arm; Developed severe itching from head to toe; I was running a temperature of 102; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; Appetite lost; Chills; soreness more than usual from the shot; Soreness in my arm, my neck; Soreness in my arm, my neck/ pain around her face, her left arm; I got stiff neck, my back, my lower back; Massive weakness; Confusion; terrible sleepiness; Diarrhea; I still don't feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3248, expiration Apr2021) at 6:00AM on 07Jan2021 for Covid-19 immunization. The patient had her first dose on 19Dec2020 and had side effects from it but very few. The patient was worked at COVID rooms to clean rooms in hospital as a housekeeper and so her exposer to the hospital made her in first group to get the vaccine. Medical history included allergies (had anaphylactic shock from Amoxicillin and from Tylenol, she cannot take Tylenol), anxiety, and high blood pressure. Concomitant medications included acetylsalicylic acid (ASPIRIN) on regular basis, bisoprolol fumarate, loratadine (CLARITIN) for allergies, escitalopram for anxiety, mometasone furoate (FLONASE) for allergies, losartan, magnesium, omeprazole, and triamterene. On the first day (07Jan2021) she had soreness more than usual from the shot, soreness in her arm, her neck. She got stiff neck, back, lower back. She had gotten the shot at 6 am, then worked at that time and by the time she got home at noon, she had massive weakness, some confusion, terrible sleepiness and by evening, she developed diarrhea. On the second day (08Jan2021) the pain increased the weakness increased, and she was running a temperature of 102. She could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move pretty much. She could not eat and lost appetite, and she developed the chills on that evening. On the third day (09Jan2021) she was running a temperature of 101 so it had gone down. She still had headaches, and pain around her face, her left arm and developed severe itching from head to toe, and on the next day (10Jan2021) she developed hives on her face, on her head, on top of her back and they also itch in addition to the all over itching. The temperature was gone, she had no temperature when she developed the hives. At the report day, she stated that she had not gone back to work as she broke out in the horrible hives and she still did not feel good. Only cold ice packs on the hives/ itching and no more treatment received for the events. The fever and itching resolved on 10Jan2021, and outcome of all other events was unknown.
74 2021-01-24 weakness Lack of energy Feel exhausted
74 2021-01-24 numbness Slight numbness in the left cheek (face) down into the left arm, increased anxiety, Pt vitals checke... Read more
Slight numbness in the left cheek (face) down into the left arm, increased anxiety, Pt vitals checked and 1 25mg of Benadryl given PO, Pt rested approx. 2 hours before she felt comfortable to leave
74 2021-01-26 flushing Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccine patient felt flushed. Vital signs... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccine patient felt flushed. Vital signs taken and all within normal ranges. Patient observed for thirty minutes after vaccination and at end of observation period stated they felt a sensation of throat closing. No rash, shortness of breath, or uticaria noted. Patient took one dose of diphenhydramine 25 mg by mouth and symptoms resolved. Repeat vital signs remained within normal ranges and no new symptoms developed. Patient discharged from vaccination clinic to home stable.
74 2021-01-27 tingling Lower leg weakness and tingling. Taken by ambulance to hospital. It was treated as an allergic react... Read more
Lower leg weakness and tingling. Taken by ambulance to hospital. It was treated as an allergic reaction and she was released the same day.
74 2021-01-27 weakness, muscle spasms Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, ... Read more
Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, not able to do much No appetite Urine strong odor, different color, and frequent Cramping in hands and feey
74 2021-01-27 breast pain, pain in extremity tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, up... Read more
tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included anxiety (needed to calm down), blood pressure abnormal, blood cholesterol abnormal, rheumatism, and osteopenia; all were ongoing. Concomitant medications included losartan potassium for blood pressure abnormal, atorvastatin blood cholesterol abnormal, sulindac for rheumatism, carvedilol for blood pressure abnormal, alendronate sodium for osteopenia, and venlafaxine; all were ongoing. On 12Jan2021, the patient experienced strong pain on her shoulder, upper arm, breast and neck area. On an unspecified date, the patient was also tired. Clinical outcome of event tired was unknown while for the other events was recovered on 13Jan2021.
74 2021-01-28 feeling hot 15 minutes after receiving injection, I began feeling very warm and it felt like I had a lump on the... Read more
15 minutes after receiving injection, I began feeling very warm and it felt like I had a lump on the right side of my throat. I was monitored in the ER, seen by the doctor and given 25 mg of Benadryl. My BP was high. I was discharged after approximately an hour and a half after incident. THESE WERE MILD SYMPTOMS. I was told to take Benadryl for the next 48 hours, which I did.
74 2021-01-28 pain in extremity Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours aft... Read more
Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours after vaccination Symptoms still present, but beginning to improve after 48 hours
74 2021-01-28 pain in extremity, discomfort it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; ... Read more
it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; couldn't get to sleep; rash looks like little blisters; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Nov2021), via an unspecified route of administration on her left arm on 12Jan2021 12:40 at a single dose for her age (COVID-19 immunization). Medical history included blood pressure (abnormal) and surgeries (had so many surgeries but none recently). Concomitant medications included ongoing atorvastatin for more than a year for blood pressure, ongoing amlodipine for more than year for blood pressure, ongoing losartan for more than year for blood pressure and ongoing terazosin from 09Dec2020 for blood pressure. The patient got her first injection on 12Jan2021 Tuesday and the following day (13Jan2021) she broke out with a rash on her right arm, right under her wrist and where you bend arm. She was asking if this a normal or expected side effect. The patient mentioned it was not in the arm where she received the vaccine. The rash was located in four places on her right arm; at the bend; maybe about two inches from where she bends it; a little bit on the outside of the arm and at the inside of her wrist. Last night (14Jan2021) she went to bed at 11PM and couldn't get to sleep until 3:00AM due to the pain and discomfort with her arm. Now (15Jan2021), it itches quite a bit. She put Neosporin (31254-7238-090 Lot 3259L or a 1 2/1 Expiration date Oct2021) on it and it helped but then when it dries up she can feel the itching again and was painful. The rash looks like little blisters. She is planning to get the next dose; she has to call in. Her next dose is due by 02Feb2021. The events did not require a visit to physician or ER. No prior vaccinations (within 4 weeks). The outcome of the events rash looks like little blisters, Pain in arm and it itches quite a bit/ Itching was not recovered and it was unknown for the other events.
74 2021-01-30 pain in extremity Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body ac... Read more
Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body aches and chills. Left arm sore for three days.
74 2021-02-01 weakness Altered mental status; Chest pain; Elevated troponin; Generalized weakness
74 2021-02-01 weakness Cant get her breath, intensely weak, chills.
74 2021-02-03 pain in extremity Pain in left arm and at injection site; Pain in left arm and at injection site; Large bruise; This i... Read more
Pain in left arm and at injection site; Pain in left arm and at injection site; Large bruise; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received BTN162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: E13246, expiration date was unknown), via an unspecified route of administration on the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the public health clinic/veterans administration facility. Relevant medical history included allergies to Penicillin. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Jan2021, the patient experienced pain in left arm and at injection site and large bruise, which were assessed as non-serious. One week after the injection, she still had pain in left arm and at injection site and also a large bruise. The patient did not receive any treatment for the adverse events. The patient was not recovered from all the events.
74 2021-02-03 feeling cold she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; ... Read more
she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; fogginess/Foggy brain was described as she was not able to focus very well; Strong chills was not going away almost like a feeling of ice in her veins; Arm ache at the site; She was not able to get work done due to extreme fatigue and foggy brain/It was very disturbing and interfering with ability to do work; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had her first COVID19 vaccine dose. Immediately, on 16Jan2021, she felt very cold and unwell. She also experienced dizziness, headache that started right after the shot, extreme fatigue that started later in the day and fogginess that started right after the shot. Strong chills was not going away almost like a feeling of ice in her veins. She is taking paracetamol (TYLENOL) and ibuprofen for these. The events were not improving. She was just surprised, she was ok with a day's worth, but it was hanging on dizziness (not enough to fall down), but she has to hold onto a rail to go upstairs which was not normal. She doesn't feel like she is real anchored. Headache was described as very bad and is not changing. Foggy brain was described as she was not able to focus very well. She was not able to get work done on Jan2021 due to extreme fatigue and foggy brain. She also experienced arm ache at the site on 06Jan2021 for which the patient expected. It is reducing some, the ache is not as bad as it was while the other things seem to be growing and it is still there. She had to be set aside when she took the shot, because she had these reactions after she got the shot. She had to be watched because of her almost immediate reactions. The patient wants an advice on what to do now, if there is any help for the side effects, and if this will go away. It was very disturbing and interfering with ability to do work. Outcome of the vaccination site pain was recovering while of the remaining events was not recovered.
74 2021-02-04 pain in extremity, feeling cold First dose : Second day of vaccination very mild fatigue , moderate pain in arm Second dose : ... Read more
First dose : Second day of vaccination very mild fatigue , moderate pain in arm Second dose : pain in the arm began the day of vaccination, second day at noon began chills, fatigue, joints pain and and fever at around 4 pm , highest reading 100.4 Third day feeling good for
74 2021-02-04 feeling cold Patient felt cold, some shortness of breath right after vaccine. Experienced anxiety too. Given wate... Read more
Patient felt cold, some shortness of breath right after vaccine. Experienced anxiety too. Given water and apple juice - felt better and was discharged to home. Vitals: 168/96, 162/86 (pulse 68). O2 sat 100%.
74 2021-02-04 tingling after receiving vaccine patient had 2 lumps on site ; some redness at the site of injection; experie... Read more
after receiving vaccine patient had 2 lumps on site ; some redness at the site of injection; experienced some tingling in the face, and head .
74 2021-02-04 pain in extremity received BNT162B2/ medical history included ongoing breast cancer; received BNT162B2/ medical histor... Read more
received BNT162B2/ medical history included ongoing breast cancer; received BNT162B2/ medical history included ongoing breast cancer; sore arm; This is a spontaneous report from a contactable healthcare professional. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history included ongoing breast cancer. Concomitant medications were not reported. The patient previously took palbociclib (IBRANCE) in Oct2019, Sep2020, then in Dec2020 for breast cancer and experienced diarrhea, mouth sensitivity, lowered white blood, tired, hair loss, fluctuating blood sugars with insulin adjustment. On an unspecified date in Jan2021, the patient experienced sore arm. The outcome of the event was unknown. Information on Lot/Batch has been requested.
74 2021-02-05 pain in extremity About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site p... Read more
About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site pain and swelling, muscle and joint pain, feeling unwell
74 2021-02-05 pain in extremity Unable to lift arm and soreness. Flu like symptoms - muscle aches, chills, headache
74 2021-02-06 tingling, numbness 30 minutes after injection started noticing numbness and tingling in left arm. It also went to left ... Read more
30 minutes after injection started noticing numbness and tingling in left arm. It also went to left side of my face. Felt like Novocain after a dentist visit. Also had high blood pressure. 232/100
74 2021-02-06 pain in extremity From the point of injection in the left deltoid down to the elbow the arm was red, hot, stiff, and s... Read more
From the point of injection in the left deltoid down to the elbow the arm was red, hot, stiff, and swollen. Patient reported pain as well as itching in the swollen part. Arm was also bruised the size of a half dollar at the injection site. Dr. diagnosed her with cellulitis after immunization and prescribed her amoxicillin 875mg twice daily for 10 days.
74 2021-02-07 tremor Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning... Read more
Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning plastic; Taste started to diminish; Painful bilateral lower back pain; Cough/Dry cough; Bad headache; Severe shaking chills; Muscles and joints ached; Muscles and joints ached; This is a spontaneous report from a contactable nurse (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration at left deltoid on 20Jan2021 at 9:30-9:45 am at SINGLE DOSE for COVID-19 immunization. Medical history included exposure to radiation from 2017 to an unknown date and did lose some of her sense taste due to 2 massive doses of radiation in 2017). There were no concomitant medications. Historical vaccine included two doses of shingles vaccine (SHINGRIX) for Immunization and experienced shaking, chills, and muscle and joint pain after the vaccine. The patient experienced bad headache (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, Severe shaking chills (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, muscles and joints ached (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, couldn't hold a cup to drink on an unspecified date with outcome of unknown, painful bilateral lower back pain on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, cough/dry cough on 20Jan2021 17:00 with outcome of not recovered (reported as worsened), strange odor in her nose, like burning plastic on 21Jan2021 with outcome of not recovered, taste started to diminish on 21Jan2021 with outcome of not recovered, pharangitis on an unspecified date with outcome of unknown, couldn't get warm on an unspecified date with outcome of unknown. Details were as follows: the patient received the COVIED in the morning of 20Jan2021. By 5pm she had developed a headache, severe shaking, chills, muscle and joints pain, severe lower back pain, and a dry cough; she was miserable. A few years ago after her double dosing of the shingles vaccine she had a similar reaction of shaking, chills, and muscle and joint pain. She has no product details for that product, no NDC, Lot, or expiry to provide. The patient confirmed that the shingles shot was 2 doses, not a double dose given at one time. When asked a seriousness criteria it was explained that the symptoms that started on the 20th, she felt they were disabling. She couldn't get warm, stop shaking, couldn't hold a cup and the pain was severe and she has high tolerance for pain. By around 3pm that day on the 21Jan2021 everything but the dry cough had resolved, and that had gotten worse. She also developed new symptoms. She had strange odor in her nose, like burning plastic and her sense of taste started to diminish. She did lose some of her sense taste due to 2 massive doses of radiation in 2017, She has no product information, NDC, Lot or Expiry for that radiation but after that she did have taste, some of it did come back. On the 21Jan2021, it was less, the sense of taste and now today she has no taste at all. For the muscle and joint pain she took Aleve. She was told if she was feeling worse over the weekend to go to the ER or urgent care. The patient was wondering and thinking this was her normal response to the vaccine just like she had a normal response that shingles vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
74 2021-02-09 pain in extremity Heart beat is high/I am having my heart beat is fast and usually it's low, I just feel weird; Sore o... Read more
Heart beat is high/I am having my heart beat is fast and usually it's low, I just feel weird; Sore on the arm; This is a spontaneous report from a contactable consumer reporting for self. This 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included acid reflux, stomach relaxer, IBS (irritable bowel syndrome). Concomitant medications included hyoscyamine sulfate for stomach relaxer, omeprazole (PRILOSEC), Vitamin D2, omeprazole for acid reflux. On 23Jan2021, the patient experienced heart beat was high, she was having heart beat was fast and usually it's low, she just feel weird, and also experienced sore on the arm. No treatment received. Lab data included Height: 5ft 5 inches and weight: 140 pounds on unspecified date. The outcome of events was not recovered. Information about lot/batch number has been requested.
74 2021-02-10 breast pain she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to... Read more
she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.
74 2021-02-17 tremor, weakness Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kid... Read more
Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kidney failure and allergic reaction; Allergic Reaction; still wasn't feeling normal; Could not keep head up and was in bed; breathless; extreme fatigue; exhausted and weak; Heart was banging fiercely; Totally dehydrated; Urinating a great deal more; Chills, shakes and felt terrible; Chills, shakes and felt terrible; sicker every single day/sick/felt terrible; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on the left arm on 18Jan2021 14:30 at a single dose for prevention for COVID. Medical history included hip replacement on 04Jan2021 and fibromyalgia (When her children were younger, she was told she had Fibromyalgia). Family history includes diabetes (father late onset) and very rare cancer (mother). There were no concomitant medications. It was reported that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and got sick the next day (19Jan2021). She also mentioned that she got sicker every single day. Then after 8-9 days, she said she started to feel better, but still wasn't feeling normal. She said she had extreme fatigue, was breathless, and felt exhausted and weak on an unspecified date. She said she was supposed to receive the 2nd dose of the vaccine this Monday (unspecified date), but because of her side effects, she was told that she can come back to receive the 2nd dose after 6 weeks. She wants to know if this is acceptable. The patient reported that on 19Jan2021, she woke up in the middle of the night with chills, shakes, and felt terrible. She cancelled her plans for Tuesday (as reported). On Wednesday, she forced herself to get up and went out for lunch and came home. She could not keep her head up and went back to bed and that lasted several days. It got worse before it got better. She ended up being hospitalized for 4 days (25Jan2021 to 29Jan2021). It appeared to be she was in Kidney Failure and experienced allergic reaction on 25Jan2021 and her white blood cell count was elevated (unspecified date). She went to the ER and they kept her 6-8 hours and discharged her on a Friday and by Monday, she was admitted to the hospital. The first ER visit, she was there for 6-8 hours and they sent her home. They gave her IV fluids and took a lot of tests. The patient's first ER visit was on 22Jan2021, and was kept for 6-8 hours and released. She was given IV fluids and they did a lot of tests. She went to see her doctor and sent her to the emergency room. They took her blood, EKG and everything seemed ok. Creat was 1.0 and by Monday it was 1.6 and then on Friday it was 1.9 (unspecified dates). She was admitted to hospital on Monday and they gave her IV fluids and did kidney test and admitted her as soon as she could get a room. She never had a problem before with her kidneys. They did bacteria test and they were normal. The patient called her doctor on 24Jan2021, because she was nauseous, dizzy, and room was spinning and she felt worse. She went to his office on Monday morning and he put her right in the hospital (unspecified date). She got worse and now it is improved. Heart was banging fiercely on 22Jan2021 20:00. They took an Echocardiogram. She has never had a cardiac problem and could not find anything wrong with her heart. The patient started feeling a bit better. She was sick as can be through Sunday. By Tuesday (unspecified date), she was a little better and today is a little better. She is urinating a great deal more because of fluids, but later said it started the day after she got it. She had to get an aide to take care of her. The patient experienced totally dehydrated on 22Jan2021 14:00 and urinating a great deal more on 19Jan2021 03:00. Therapeutic measures were taken as a result of kidney failure, allergic reaction and white blood cell count was elevated. The outcome of the events sicker every single day/sick, chills, shakes and felt terrible was not recovered; event could not keep head up and was in bed recovered with sequel; events nausea, dizziness and room spinning, heart was banging fiercely, totally dehydrated, urinating a great deal more was recovering; while unknown for the rest of the events.
74 2021-02-21 feeling cold Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then co... Read more
Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then cold chill stopped back and head ache pain continues till Saturday 20th am Tylenol was taken didn't help much I continue to get slight headache as of today 22nd Monday fine now except slight head and back pain
74 2021-02-21 seizure Had seizure 2/5/21 . Does have dx of seizures disorder
74 2021-02-22 weakness Patient finished her 15 minutes wait and made her way the vehicle. Shortly after reaching the vehic... Read more
Patient finished her 15 minutes wait and made her way the vehicle. Shortly after reaching the vehicle was feeling short of breath. Rapid response team from hospital came out and transported her to the emergency room. Most current nursing note as of 20 minutes ago, "pt complains of chest pains sob difficulty swallowing and weakness. pt is AA+Ox 4 and has a room air sat of 98% rr of 22, hr of 71."
74 2021-02-23 flushing 12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sle... Read more
12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sleep entire night.
74 2021-02-23 weakness Kidney infection; Wheezing in chest; her blood pressure is so low right now they can't even transfer... Read more
Kidney infection; Wheezing in chest; her blood pressure is so low right now they can't even transfer her to the hospital that can actually perform the surgery she needs; became very weak and didn't tell anyone/too weak to get up; mother was swollen from head to toe with edema; mother was swollen from head to toe with edema; fell using her walker on Wednesday/fell again; Laceration of face; having issues with her kidneys and has progressively declined since; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history using her walker. Concomitant medications were not reported. The consumer reported that her mother had the COVID-19 Vaccine on 21Jan2021. She was now hospitalized and was due to have the second vaccine on 11Feb2021 and stated that her mother was completely unstable for the second vaccine. After receiving the COVID-19 vaccine, medically, she seemed fine. Then, she progressively has gotten worse. First EMS was called. This was about less than a week later after receiving the vaccine. Then, she was admitted into the hospital with a kidney infection and she has progressively declined. She has no idea if it was related to the COVID-19 vaccine or not. She initially called regarding the second COVID-19 vaccine. She didn't know what would happen if her mother didn't show up for her second vaccine. She didn't know if she would get on the "never going to get the vaccine" list or what as her mother was just so unstable. On an unspecified date, her blood pressure was so low right now they can't even transfer her to the hospital that can perform the surgery she needs. The reporter stated that she has no idea if this was COVID related or what. She began having problems less than a week later after receiving the COVID-19 vaccine, she mentioned Wednesday. On 27Jan2021, her mother began having issues with her kidneys and has progressively declined since. Consumer stated her mother was swollen from head to toe with edema on an unspecified date and that was how this all kind of started. Her mother became very weak and didn't tell anyone. She fell using her walker on Wednesday and the EMS was called. Her mother told the EMS she wasn't hurt but was just too weak to get up and EMS got her up. Her primary care doctor sent her for an x-ray, and she had some wheezing in her chest. She was given an antibiotic for that. The patient fell again, and the EMS was called and had some face lacerations and stuff, so she was taken to the hospital. Consumer confirmed her mother was admitted into the hospital and was first diagnosed with a kidney infection and it has progressively gotten worse. Outcome of event kidney infection was not recovered; and outcome of the rest of events was unknown. Information on lot/Batch number has been requested.
74 2021-02-23 discomfort uncomfortable all night; itching; hives all over my body/developed giant hives all over her body/the... Read more
uncomfortable all night; itching; hives all over my body/developed giant hives all over her body/the giant hives were like fire ant bites/developed little hives on the inside of her arms, behind her knees, and on the tops of her feet; This is a spontaneous report from a contactable health care professional nurse, the patient. A 74-years-old female patient (retired nurse) received the first dose of bnt162b2 (BNT162B2, Lot Number EL9262) , via an unspecified route of administration in the right deltoid on 29Jan2021 at 11:00 (at 74 years of age) as a Single dose for Covid-19 Vaccination. The Vaccination Facility was 'movie theater'. No other vaccines were given within 4 weeks. Medical history included hypertension from 2020 ( doctor considered taking her off of blood pressure medicine because her blood pressure is very normal now), Prediabetes (diagnosed with Prediabetes about 3 years ago) and Allergic reaction to bee sting (numerous yellow jacket stings throat felt like it was starting to close, and tongue felt funny. Went to ER and Treated with Zantac and Epinephrine) and lost 55 lbs. (borderline high blood pressure was related to her weight). Concomitant medication included ongoing generic losartan (LOSARTAN) 50 mg, 1x/day for borderline high blood pressure, metformin (METFORMIN) 500 mg, 1x/day for glucose tolerance impaired. On 29Jan2021at 5 PM the patient started having some itching 'felt like she had a mosquito bite but on further investigation she noticed "giant hives all over my body'. She said she took some Benadryl Lot Number: P119923 Expiration Date: Apr2023 and 1 expired Zantac (Lot Number: NL4604, Expiration Date: Nov2019) on 29Jan2021 to help treat giant hives and itching. The giant hives 'kind of subsided' after she took the Benadryl and the Zantac, though she did remain itchy and uncomfortable all night. She said by the morning (30Jan2021) the giant hives were gone. She said that evening (30Jan2021) the giant hives came back again, and the giant hives were all over her body. She said the giant hives were like fire ant bites, she said the giant hives were just awful. She said she had a previously scheduled appointment with her doctor on Monday, 01Feb2021 (prior to developing the giant hives after her first COVID-19 Vaccine dose) but probably would have gone to see her doctor anyway, if she didn't have a prior appointment. She said she had taken pictures of her giant hives, her doctor believes the giant hives she experienced was a reaction the COVID-19 Vaccine's preservatives. She said her doctor still wants her to get the second COVID-19 Vaccine dose. Consumer stated Reported her giant hives were gone by Monday morning (01Feb2021), when she woke up. She stated during Monday (01Feb2021) into Tuesday (02Feb2021) she developed little hives on the inside of her arms, behind her knees, and on the tops of her feet. She said she has a residual itching that is lingering, but not continual. She said she has been taking one generic Zyrtec 10mg tablet per day, Lot Number: NL4604, Expiration Date: Nov2019. The events Hives and Itching was medically significant and uncomfortable was non serious. Treatment was given for itching and hives. Her doctor still wants her to get the second COVID-19 Vaccine dose. Patient second COVID-19 Vaccine dose is scheduled for 19Feb2021. The patient reported her doctor told her it would be a good idea for her to take one Zyrtec, each day, for 3 days before her next COVID-19 Vaccine dose. She said her doctor told her to pre-medicate with Benadryl on the day of her second COVID-19 Vaccine dose. The clinical outcome of Pruritus was recovering while Hives was recovered on 02Feb2021 and the outcome of uncomfortable was unknown. The events Giant hive, hives and itching were considered related to the suspect product.
74 2021-02-24 tremor Around 5 minutes after 2nd vaccination, patient states she is dizzy, shaky and feeling like she is g... Read more
Around 5 minutes after 2nd vaccination, patient states she is dizzy, shaky and feeling like she is going to pass out. Provided water, cold towel and being monitored by nurse. Denies any shortness of breath or difficulty breathing. States symptoms persist for the next 30 minutes while refusing to go to ED. Daughter arrives and instructs patient to ED. Escorted to ED with the patient still complaining of persistent dizziness, lightheadedness, and brief chest tightness which subsided within 5 minutes.
74 2021-02-24 flushing flushed in face, high blood pressure,
74 2021-02-25 bell's palsy Bells Palsy
74 2021-02-25 weakness I had heavy chills from 6pm on the 24th until 2am on the 25th. Then, more heavy chills from 6am on ... Read more
I had heavy chills from 6pm on the 24th until 2am on the 25th. Then, more heavy chills from 6am on the 25th until 1 pm on the 25th. My headache was moderate but relentless throughout those days and into the 27th. I was extremely tired, having no energy or interest in doing anything but lying down. My body ached all over and I was somewhat dizzy and nauseated. I took a Tylenol during the night of the 25th. Today is the 26th and I am still very tired and my eyes are bleary.
74 2021-02-25 unresponsive to stimuli, weakness I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM... Read more
I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM I went to bed because I didn't feel good, I laid in bed for a few minutes and then jumped up because I began to violently vomit. After I vomited I felt weak, I was sitting with my back against the wall my husband came to check on me. He walked away and when he came back I was unresponsive, laying on the floor and he said my eyes rolled in the back in of head. He called 911. I was unresponsive for about a 1-2 minutes. EMS arrived, by the time they had arrived I had crawled into bed, and they took my vitals and they were fine, they asked me if I wanted to go to the hospital but I declined as I was afraid to go. I went to sleep. The next day I felt weak and tired, I had a burning feeling in my stomach, I took some TUMS, I didn't much that day. I rested most of the next day. Yesterday I felt a little better and today I am fine. I have a doctor's appointment 2/26/2021 at 2PM to see the ARNP at my doctor's office.
74 2021-02-25 pain in extremity Painful shoulder and arm continues still, one month later
74 2021-02-25 pain in extremity Sore arm headache muscle aches fever chills
74 2021-02-25 migraine, weakness WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WE... Read more
WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WEEK 3: periodic chills, periodic headaches, weakness, periodic exhaustion, GI symptoms, elevated pancreatic enzymes WEEK 4: weakness, GI symptoms, shortness of breath, exhaustion, heart block
74 2021-02-25 burning sensation cheeks red and burning; cheeks red and burning; upper lip swelling; This is a spontaneous report fro... Read more
cheeks red and burning; cheeks red and burning; upper lip swelling; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration in the left arm on 12Jan2021 at single dose for covid-19 immunisation. Medical history included allergic to a lot of antibiotics, always get reactions to drugs. Concomitant medications were unknown. The patient previously received ciprofloxacin (CIPRO) experiencing lip swelled, levofloxacin (LEVAQUIN) experiencing lip swelled, Prednisone experiencing burning cheeks. The patient experienced that her cheeks were red and burning, and upper lip swelling slightly, all on 12Jan2021. And it lasted a little over two hours. The patient was asking if it would be safe to take Benadryl before the 2nd dose of the vaccine. Outcome of all events was recovered on 12Jan2021.
74 2021-02-25 pain in extremity still a part of her forehead that feels like a live nerve; upper back started hurting/back was very ... Read more
still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated "she got shingles on her face, 7 years ago, and had recent dental work done," specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her "arm was a little sore". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her "upper back started hurting" and thought "maybe [she] sat on the couch for too long". On 31Jan2021 (Sunday evening), she added her "back was very tender and sensitive around the spine area" therefore, she "took some tylenol and used a heating pad thinking [she] pulled a muscle". On 01Feb2021 (By Monday) she said her "the back and front were very sensitive" to the point where: when she "touched [her] skin it felt like [she] was touching some live nerves". She explained seeing a physician assistant who "couldn't figure out what was going on" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then "went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her "brother, who is a doctor, thinks [she] has post traumatic neuralgia" related to her shingles on an unspecified date in Jan2021. She then added there is "still a part of her forehead that feels like a live nerve" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown. The information on the Batch/Lot number has been requested.
74 2021-02-26 inability to speak 15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drain... Read more
15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drainage and slightly bloody nostril. Tired in evening of injection, slight soreness right are. Next day, up performing usual home kitchen activities, reading, making and drinking coffee. Then SUDDENLY at exactly 23 hours after the injection, began experiencing extreme difficulty breathing, unable to speak in full sentences. Called Primary Providers Office and was directed to go to an emergency room ASAP.
74 2021-02-26 weakness, tremor I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chill... Read more
I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chills and an all over listless feeling that started about 18 hours after I received vaccine and still remains 4 days later
74 2021-02-26 pain in extremity Itch at site, sore arm, insomnia, brain fog, out of breath
74 2021-02-26 feeling cold, tingling PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS ... Read more
PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS STARTED. SHE WAS SENT TO THE ED FOR EVAULATION.
74 2021-02-27 pain in extremity Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the n... Read more
Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the next day with a fever at 5pm of 100.5; Sunday no temperature but loss of taste, diarrhea, stomach discomfort.
74 2021-02-27 weakness, tremor Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash.... Read more
Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
74 2021-02-27 tremor, weakness Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle ... Read more
Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
74 2021-02-28 tremor At 10am on Thursday February 25, I SUDDENLY experienced the onset of violent chills, shaking so hard... Read more
At 10am on Thursday February 25, I SUDDENLY experienced the onset of violent chills, shaking so hard I couldn't initially place a thermomenter in my mouth. Moments later, this was accompanied by throbbing pain in my lower back. Eventually I was able to take my temperature and I had fever. My daughter contacted my primry care physician who told us to go the emergency room. By the time we went to hospital, the chills had stopped as well as the lower back pain. I was quarantined (though they knew I had been vaccinated for COVID) until they tested me for COVID, the test came back negative in an hour. They did a number of tests and I was discharged around 6:00 pm that evening
74 2021-02-28 pain in extremity Caller says she felt pain in her arm afterwards as well.; This is a spontaneous report from a contac... Read more
Caller says she felt pain in her arm afterwards as well.; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#:not provided), via an unspecified route of administration from on 27Jan2021 (at the age of 74-year-old) at SINGLE DOSE for COVID-19 immunization at the hospital and paracetamol (TYLENOL), via an unspecified route of administration and dates at 2 DF, daily (every morning) for aches and pains. Medical history and concomitant medications were not reported. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot#: not provided) on an unknown date at SINGLE DOSE for COVID-19 immunization and says that she had no reaction to the first shot. The patient received the second dose and had a sore arm (in Jan2021) that was better today. She stated that in the morning she always took two paracetamol for aches and pains; and after she got the first and second shot she read three articles to do not take paracetamol before you get the vaccines as it might affect antibodies. However, no one published about this or said this at the hospital when she went to get the shot, they just asked what she was allergic to it. She would like to know if now she was not so protected because she took paracetamol and if this was a problem. The action taken in response with the adverse event for paracetamol was unknown. Outcome of the event was recovering Information on the lot/batch number has been requested.
74 2021-02-28 muscle spasms, weakness I became dizzy and then nauseous, increasingly dizzy. When I told my husband that I was getting up... Read more
I became dizzy and then nauseous, increasingly dizzy. When I told my husband that I was getting up to go to the restroom, perhaps to throw up, I found that I couldn't walk or make my arms and legs move in a controlled way. He helped me to a resting place on the floor. I asked him to call 911. I thought that I was having a stroke. Emergency personnel treated it as a pot overdose, because I told them that I had a bite of a pot brownie a couple of hours earlier. It was really a little piece and I doubt that it would be enough to have these results. I developed spasms throughout my body. My hands were unable to do tasks. I did throw up once at the hospital. I think that the pot issue was parallel but not necessarily the cause. I received IVs. One med was for nausea, Not sure what all. I went home about 1 AM after dizziness had lessened and spasms had stopped. Today I am a wobbly and weak, but no spasms. And I can walk and control my arms.
74 2021-02-28 weakness Reports x 1 week s/p vaccine on 2/20/2021. C/O sharp left sided chest pain, cough, wheezing and gen... Read more
Reports x 1 week s/p vaccine on 2/20/2021. C/O sharp left sided chest pain, cough, wheezing and generalized weakness
74 2021-02-28 tingling patient c/o tingling and numbness (slight) on L arm all the way to fingertips. No itching noted. No ... Read more
patient c/o tingling and numbness (slight) on L arm all the way to fingertips. No itching noted. No c/o pain V/S 98% RA 70 HR 19 cmp 130/60 BP @2:52pm v/s 97% RA 79 HR 19cmp 120/80 Patient stable symptoms improved left at 2:57pm
74 2021-03-02 pain in extremity Sore arm with first dose; This is a spontaneous report from a contactable consumer (patient). A 74-y... Read more
Sore arm with first dose; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via intramuscular on left arm on 24Jan2021 at 18:30 at single dose for COVID-19 immunization. The relevant medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: autoimmune disease, PBC (Primary biliary cholangitis) (PBC is her autoimmune condition and was diagnosed 10 years ago). Concomitant medications were reported as none. The patient had sore arm with first dose on 24Jan2021. The outcome of the event was recovering.
74 2021-03-02 pain in extremity light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen... Read more
light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Did not sleep well overnight (always do) and woke up very tired; sick to stomach; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248, expiry date not reported), via an unspecified route of administration in the left arm on 30Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Raynaud's phenomenon. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received fluvastatin sodium (LESCOL) and experienced drug hypersensitivity, and nifedipine (ADALAT) and experienced drug hypersensitivity. On 30Jan2021 17:30, in the evening the patient became light headed, had a slight headache and was tired. Her upper arm became sore and a bit swollen. She did not sleep well overnight (always do) and woke up very tired, sick to stomach. Her upper arm was more swollen and sore. No therapeutic measures was taken as a result of the events. Clinical outcome of the events was recovering.
74 2021-03-03 flushing 10:00 patient received second pfizer vaccine 10:40 reported feeling a flushing sensation x 1 approx... Read more
10:00 patient received second pfizer vaccine 10:40 reported feeling a flushing sensation x 1 approx 10:30, provided bottled water to drink, denies any difficulty breathing, throat swelling, or tongue swelling 11:00 finished bottle of water feeling fine left vaccine clinic accompanied by her husband 11:30 returned to vaccine clinic c/o thick tongue and difficulty swallowing, denies difficulty breathing. Sent to ED. ED note states that patient presented after "near syncopal episode" after developing lightheadedness and flushing after vaccination. Similar episode an hour later (prompting return to medical center). Denied chest pain or shortness of breath on presentation to ED. Described difficulty swallowing and "thick tongue" leading to her presenting back to clinic, but asymptomatic when arrived to ED. Oropharynx free of any swelling. EKG done but only showed sinus bradycardia. Patient observed multiple hours then discharged without any medical intervention taken.
74 2021-03-03 numbness Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too ... Read more
Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too much of anything, just sit/ sick; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9269), intramuscular from 30Jan2021 17:00 (5pm) in the left arm at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a Pharmacy (Pharmacy/drug store). Medical history included ongoing thyroid condition diagnosed at least 10 years ago. Concomitant medication included levothyroxine (LEVOTHYROXINE) at 50mcg tablet once a day by mouth (Taking it for years) for Thyroid/ thyroid condition. For prior vaccinations: The higher dose, senior dose of the flu shot (for immunization), she stopped taking it when the lower dose came out. She gets very sick with the senior dose. She does not know the name and does not have lot number of the senior dose of the flu shot to provide. It was stated to the patient that there may be too much protein in it. The patient is asking if she should get 2nd dose after having negative experience post vaccination of 1st dose. The patient received first dose of vaccine on sat (30Jan2021) evening. It was reported that as soon as she got to her car, "I thought I felt numbness in my cheek. It didn't stay, went right away. My husband thought i was just nervous. It was also stated that she then started "getting nauseous" about 30min after vaccine. The patient has "been sick since I had it.. not sure if its normal? It was also reported that she "had the runs" (diarrhea) for one day, that has now resulted. It was also said that "I'm not feeling good. cant do too much of anything, just sit". The patient asked if this is normal and "when will I feel better"? It was also reported as she had the first dose of the Pfizer covid vaccine late Saturday afternoon at 5pm. She has been feeling nausea and sick since then. She asks if this is normal and how long it will stay. The treatment used was taking Tylenol. It was noted that if she does not do anything and lays down it will go away but if she starts doing too much she will get real nauseous again. It was added that the patient and her husband went to get the vaccine on the same day. It was noted that she felt a little numbness on her face, in her right cheek and then it went away after 20 to 30 seconds. Her husband said she may have been nervous and may have caused that herself. She is a hyper type. The outcome of the event Felt numbness in my cheek recovered on 30Jan2021; for all other events was unknown. There was no additional vaccines administered on same date. No events requires visit to emergency room or physician office. No prior vaccinations (within 4 weeks) reported.
74 2021-03-03 pain in extremity Severe pain (entire arm) and redness; feverish/temperature fluctuations-highs and lows for her; extr... Read more
Severe pain (entire arm) and redness; feverish/temperature fluctuations-highs and lows for her; extreme itching at site; lethargy; reporter let person know these events not terribly unusual, vaccinee (sp?) wanted to report because continuing to have this
74 2021-03-03 pain in extremity, feeling hot Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right... Read more
Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right arm; A little headache at the back of the head; Itching; More pain when l lift my arm, my arm pits/Hurting under her arm when she was lifting; Swollen glands; My temperate was 100.8; had difficulty lifting her right arm; Tired, very tired; Tenderness at vaccinate site; More pain when l lift my arm, my arm pits/pain in arm/pain in her right arm/a lot of pain; I feel tugging and redness when I raise my arm, It's not red its blotchy; I feel tugging and redness when I raise my arm, It's not red its blotchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly at site of right arm on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included (synthroid: Taking for years), prevent urinary tract infection (UTI) (methenamine: started a year and a half ago), vitamin supplementation (Preservision Areds 2 eye vitamins more than a year ago; Vitamin C with Zinc 8-9 months ago), dry eyes (Thera tears: dry eye therapy. she has not been consistent with taking), cholesterol (simvastatin: taking 20 years or more), allergic to Sulfa Drugs and Tetracycline, obesity (had been fighting it for 30 years), removed polyps (had a flat polyp that was a little more dangerous the first time and it was removed; non-cancerous), got the flu (08Jun months later, got the flu, went to the hospital and developed PNA) and eczema (took calcium 1200mg). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid; methenamine for prevent UTI; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) for vitamin supplementation; ascorbic acid, zinc (VITAMIN C WITH ZINC) for vitamin supplementation; carmellose sodium (THERA TEARS) for dry eyes; simvastatin for cholesterol; calcium for eczema. The patient previously took Flu vaccine (Injection site was left arm, intramuscularly) in Oct2018 and experienced pain in injection site and redness in arm; took the first dose of BNT162B2 with lot number: EL3246, intramuscularly in left arm site at 09:00 on 08Jan2021. Clinical course: After the second dose of vaccination, patient noticed tenderness at vaccinate site at 13:00 and had pain in arm on 28Jan2021, but on 29Jan2021, the pain was worse, and she had difficulty lifting her right arm at 16:00. On 30Jan2021, she started noticing more pain when she lifted her arm, her arm pits, it was hurting under arm when she was lifting. She thought maybe there were swollen glands but did not feel it. her temperate was 100.8, and she took some paracetamol (TYLENOL), by the evening, her temperature was at 98.6 normal. On 31Jan2021, she noticed a lot of pain, itching and redness, redness moved from actual site down her arm about 6 to 7 inches at 14:00. The pain in her right arm was not as bad as it was, but the redness in the area and itching was there, it was hot to touch area on right arm, and she tried cold compresses and took paracetamol. Also, it was hurting under her arm when she was lifting. She experienced something like that before with a Flu vaccine. She noticed when she looked it up, the information states, yes. And it was still going on today, not so much pain, just swelling and redness, looked like what Moderna calls a covid arm. She had no temperature, a little headache on 31Jan2021 at the back of the head and tired, very tired, she was tired from 29Jan2021, and was better from 01Feb2021. She took paracetamol last night, and cold compress. she used to take baby aspirin; she didn't know if it would be a problem. She read not to take paracetamol or ibuprofen before vaccination. She felt tugging and redness when she raised her arm, it was not red its blotchy. She didn' t feel any swelling. The last 7 to 8 months, she was running high blood counts, 12.3 (high) and she had no infection, her doctor was a little nervous, the last one on 15Jan2021, it was down to 10.2 within normal range. Her immune system was very active. She had a flu shot in Oct2018 at age of 72 y/o and by 08Jun months later, she got the flu. She went to the hospital and developed PNA. In 2019 and again this past Aug2020, she had a Colonoscopy where they removed polyps. She had a flat polyp that was a little more dangerous the first time and it was removed. It was non-cancerous. The doctor was just watching it. Last blood results were 2 weeks prior to having first shot on 15Jan2021. The only thing that showed was her Liver enzymes were a little elevated. She was told that if she hadn't gotten the vaccine, it would have been worse, her doctor gave me the zpack. They were calling it a subcutaneous sensitivity, she had eczema, she forgot to mention that. She was taking calcium 1200mg, she forgot to tell her that also. The outcome of events pain in arm, redness and feeling hot was not recovered; of events tiredness, body temperature increased, itching and headache was recovering; of rest events was unknown.
74 2021-03-03 pain in extremity The next night after getting my 2nd dose the upper part of my arm swelled 3 times the size of my arm... Read more
The next night after getting my 2nd dose the upper part of my arm swelled 3 times the size of my arm normally. The very next morning I woke up to my whole arm hurting and being swollen down to my wrist.
74 2021-03-03 pain in extremity Within 4 hrs of receiving the vaccine (on Saturday), developed headache, fever, chills, sore throat,... Read more
Within 4 hrs of receiving the vaccine (on Saturday), developed headache, fever, chills, sore throat, sore arm, fatigue. Symptoms faded during following day (Sunday) and by Monday left only with fatigue which resolved by Tuesday.
74 2021-03-04 burning sensation After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning,... Read more
After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning, itching, soreness and can't sleep on that side.
74 2021-03-04 weakness Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and ... Read more
Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and then go away; Nauseous; No dizziness, but unsteadiness; Tired; Headaches; began to feel a little bad/ generally didn't feel well/Malaise; Feels like the stomach flu; Weak; Gentle muscle ache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration on 28Jan2021 15:30 in left arm at single dose as Covid vaccine, etanercept (ENBREL, 50 mL/mg, Solution for injection in pre-filled pen, lot number: 1119808, expiry date: Apr2023) via an unspecified route of administration from an unspecified date and ongoing at 1 DF weekly to the stomach area for rheumatoid arthritis, methylprednisolone (MEDROL, tablet) oral from an unspecified date and ongoing at 3 mg, daily (1.5 tablets daily for total of 3 mg) for rheumatoid arthritis, methotrexate (tablets) oral from an unspecified date and ongoing at 20 mg, weekly (2.5 mg tablets, 20 mg total) for rheumatoid arthritis. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity) and took levothyroxine, rheumatoid arthritis. She had had regular blood work for rheumatoid arthritis and that was normal for her, they were relatively normal and her ESR was down. No additional vaccines administered on same date of BNT162B2. No other vaccines given the same day or 4 weeks prior. The patient's concomitant medications included levothyroxine daily for endocrine abnormalities. It was a daily thing for the body and the body couldn't live without it if it did not have it. The patient previously took the Shingrix vaccine and it was terrible for her and put her into a rheumatoid arthritis flare and was taking prednisone and was getting better and the wap she was in a rheumatoid flare. No prior vaccinations received within 4 weeks prior to the first administration date of the suspect vaccine. The patient was taking 3 medicines for rheumatoid arthritis that might or might not affect the RNA in the vaccine. She wondered if etanercept would have an effect on the vaccine since it was shipped on ice overnight. She did not think they would affect anything. Nobody has said anything about the medications and she just wanted to get the vaccine. Her doctor knows nothing about the interactions and none of them seem to know if it is normal to have these symptoms 4 days after getting the vaccine. She felt great the first 2 days after getting the vaccine and then began to feel a little bad. She was having some symptoms maybe 4 days on 01Feb2021 after receiving the Covid vaccine and wanted to know if that was sort of normal. It was unusual for her, but she had nauseous, not dizziness, but unsteadiness, tired, also headaches and generally didn't feel well. She felt like she might have the stomach flu, but had not had that in so many years. She also felt weak. No temperature. Gentle muscle ache. On 01Feb2021 Monday night she had the nausea. On 02Feb2021 Tuesday, she had it again, and had it again today and almost threw up last night. Just the malaise or tiredness had gotten worse. She could not tell the difference between the rheumatoid arthritis, joint pain and muscle pain and this with the vaccine. She was having a few little odd pains, but nothing that she hadn't had before. It was more of a soft pain, they made her feel weak and then they went away. It was more muscle than joint. The events did not require a visit to emergency room or physician office. She was supposed to get a second dose but felt she shouldn't, it might put her back into a rheumatoid flare. She was just getting over it and afraid to go through that with the Covid vaccine also. The action taken in response to the events for etanercept, methylprednisolone and methotrexate was dose not changed. The outcome of events nausea, unsteadiness, tired (tired was reported as worsened), generally does not feel well, feels like the stomach flu, weak, few little odd pains; soft pain, joint pain was not recovered, of other events was unknown.
74 2021-03-04 pain in extremity Enlarged nymph node under left armpit Swollen left arm with pain along the inner left arm
74 2021-03-04 pain in extremity Felt like the flu that night & all the next day. Achey, painful joints, off-balance slightly, chill... Read more
Felt like the flu that night & all the next day. Achey, painful joints, off-balance slightly, chills, no fever that i know of, headache, extremely painful left arm up & down, into shoulder & scapula. . Stayed home all day., took Tyleno, benedril dye free the day after injection when feeling so bad
74 2021-03-04 pain in extremity I received the first Covid shot. After a few days of soreness, it became itchy. Red blotch on arm... Read more
I received the first Covid shot. After a few days of soreness, it became itchy. Red blotch on arm that itches
74 2021-03-07 weakness Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with na... Read more
Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with nausea, vomiting, and diarrhea for 3 days. Tested COVID 19 positive. Found to be hyponatremic. Was treated with IV fluids. Discharged on 3/6/21. Follow labs on 3/8/21.
74 2021-03-07 feeling cold, tremor tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Head... Read more
tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Headache; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 74 years of age), via an unspecified route of administration in the arm on 01Feb2021 at a single dose for protection against COVID-19. She will be 75 in September, date of birth unknown. Medical history included cancer in which she doesn't know when was diagnosed but was supposed to be cancer free and hypertension. The patient's concomitant medications were not reported. The patient got to the ER last night (01Feb2021), she went to the health department to get the shot, then the ER. It was reported that last night, the patient was shaking like Parkinson's- she was cold, her tongue swelled, and she had a headache. The patient was not admitted. Shaking like Parkinson's, cold outcome: the patient felt better, she was a little quivery, but was given a steroid and IV last night, and her tongue was not swollen now. Headache: is still ongoing, but improving, she still has it. The outcome of tongue swelled was recovered on an unknown date; shaking like Parkinson's- she was cold and headache was recovering. Therapeutic measures were taken as a result of the events.
74 2021-03-09 feeling hot, flushing, pain in extremity her face flushed out; she got hot and sweaty; she got hot and sweaty; for three days following getti... Read more
her face flushed out; she got hot and sweaty; she got hot and sweaty; for three days following getting the vaccine, she felt like she had been punched in the arm; she is losing her voice; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL1283 and expiry date was unknown) via an unspecified route of administration, into left arm on 15Jan2021, as single dose for COVID Prevention. Medical history and concomitant medications were not reported. Patient stated that quickly after getting the vaccine, her face flushed out, and she got hot and sweaty. For three days following getting the vaccine, she felt like she had been punched in the arm, she was not just sore, but it felt like she had been punched. Stated that she was losing her voice. Patient received no other vaccines on the same day as the COVID vaccine. Patient wondering if other people are having the problem with the face flushing from the vaccine. Outcome of the events was unknown.
74 2021-03-10 one side paralysis 74 y.o. female with a history of hypertension and hyperlipidemia who was admitted to this hospital o... Read more
74 y.o. female with a history of hypertension and hyperlipidemia who was admitted to this hospital on February 25, 2020 4 hours after the development of left-sided weakness. She was found to have an acute ischemic stroke. She has had slow progression with therapy but is now able to ambulate with a walker. She is in need of further rehab, hence the transition to swing bed. She denies any new complaints today, including headache, chest pain, shortness of breath, palpitations or feelings of tachyarrhythmias. The sensory deficits on the left side have improved in particular in her left upper extremity. She is noting some improvement as well and strength. No new focal neurological deficits
74 2021-03-10 slurring optical neuritis; inability to move, chew, eat, etc.; inability to move, chew, eat, etc.; neurologic... Read more
optical neuritis; inability to move, chew, eat, etc.; inability to move, chew, eat, etc.; neurological damage; unable to speak; changes in her eyes; Her right eye was bulging; Neither eye looked in the same direction, or able to track objects; known allergies: Apparently the Covid Vaccine by Pfizer; This is a spontaneous report from a contactable consumer. The consumer reported two reports for two separate vaccine doses for the same patient. This is the first of two reports. A 74-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included advanced stages of Multiple Sclerosis, Diabetes, depressant, covid prior vaccination. The patient's concomitant medications included diabetic meds (pills), anti-depressants, etc. The patient previously received the first dose of BNT162B2 in Dec2020 at age of 74 years old for COVID-19 immunization and experienced neurological setback and it wasn't terribly obvious at that time. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. The patient (mother of the reporter) suffered a neurological setback following the first injection, although it wasn't terribly obvious at that time, in comparison to what occurred after she received the second vaccine. The patient suffered major neurological damage after the second vaccine; unable to speak, followed by an inability to move, chew, eat, etc. The reporter also noticed optical neuritis or changes in her eyes. Her right eye was bulging. Neither eye looked in the same direction, or able to track objects. The patient was currently in a long term acute hospital (pending clarification) with a tracheostomy and a food peg. She had advanced stages of Multiple Sclerosis. Reporter had since learned she had been advised by her MS doctors NOT to receive flu shots. The reporter had known this and would not have listened to the doctors at the nursing home, who recommended she receive the Covid Vaccine. This was serious. The reporter was awaiting medical records, which would provide exact dates, times, etc of the administration of the vaccines. Adverse events resulted in Disability or permanent damage. Known allergies: Apparently the Covid Vaccine by Pfizer. If treatment adverse events: unknown. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included unknown covid test: negative in Jan2021 (post vaccination). The outcome of the events was not recovered. Information on the lot/batch number has been requested.
74 2021-03-11 weakness weakness, cannot walk, swelling of extremities, could not swallow, gallbladder enlarged and removed,... Read more
weakness, cannot walk, swelling of extremities, could not swallow, gallbladder enlarged and removed, hospitalized for 14 days. Gullian barre syndrome.
74 2021-03-14 facial pain, numbness lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her fa... Read more
lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her face/incredible face pain, throbbing; slept most of the two days following the vaccine; face became bright red with swelling and intense in her cheeks and forehead; face became bright red with swelling and intense in her cheeks and forehead; disoriented; dizzy/wooziness; This is a spontaneous report from a contactable consumer herself. A 74-years-old female patient started to receive bnt162b2 (Pfizer-Biontech covid-19 vaccine, Solution for injection lot number: EN5318 and expiration date: unknown) intramuscularly from 29Jan2021 18:10 at single dose for prevent covid. Medical history included stroke from Apr2018 to an unknown date since she had a stroke 3 years ago. Concomitant medication included rivaroxaban (XARELTO) for stroke 30 mg, once a day. The patient previously took diphtheria vaccine. Caller states she spoke to safety agent and gave them all of her information. Caller states she received the first dose of the Pfizer COVID vaccine Friday at 6:15 pm. Caller states after waiting the recommended 15 minutes at the vaccination facility after receiving the first dose caller states four minutes later she began to experience lower jaw numbness that lasted a few seconds 29Jan2021. Caller states her face became bright red with swelling and intense in her cheeks and forehead In Jan2021. Caller states these symptoms were only in her face and no where else. Caller states she was taken back to the vaccination facility and the nurse monitored her every ten minutes for about 30 minutes until she cooled down and then she was sent home. Caller states during this time she was disoriented and dizzy In Jan2021. Caller states the next day she experienced pain in her face and to this day she still gets some pain but no more redness in her face. Caller states she is scheduled for the second dose on 19Feb2021. Caller states she read somewhere online that if you had a severe allergic reaction to the first dose you should not receive the second dose. She stated that within roughly five minutes of receiving the vaccine that she began to experience a numbing in the chin and the surrounding area. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She also experienced wooziness and a dizziness. She said the experience subsided in approximately 40 minutes of its onset. She is scheduled to receive the second dose on the 19th of Feb, but has some concerns about receiving it due to her experience. The patient had Fatigue, Headache in 29Jan2021. She clarifies her slight headache pain came back with the fatigue, reports it comes and goes. Her headache is off and on. After about 5 minutes of waiting she felt a little numbing in her jaw on the right side. Then 2 minutes later her face got bright, bright red, like there was real heat coming from it. She also had swelling in her face. It was very strange. She is asking if it is safe to get the second dose which is scheduled for 19Feb2021. This reaction lasted about 40 minutes. Her face was all flushed and burning hot red. It took a couple of hours for her face to come back to her normal color. After this faded, she reports she was left with incredible face pain, it was throbbing. She was extremely fatigued and is still fatigued, she can do very little. She is managing to cook. She slept most of the two days following the vaccine. The outcome of the events Numbness recovered on 29Jan2021,red face recovered in 2021, event pain in her face/incredible face pain, throbbing recovered in 31Jan2021, event Fatigue was recovering and other events unknown.
74 2021-03-15 pain in extremity left thigh became painful, it seems its the muscle on top of the thigh. Most painful at hip site and... Read more
left thigh became painful, it seems its the muscle on top of the thigh. Most painful at hip site and at out side of left knee, sometimes directly in middle.
74 2021-03-17 seizure Resident had a seizure on 01/30/2021 at approximately 3:15PM.
74 2021-03-18 discomfort, breast pain, pain in extremity Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breast... Read more
Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breasts are very sensitive and sore; Breasts are sensitive/Her breasts are very sensitive and sore; Swelling in her calves, her left and right arms; Swelling in her calves, her left and right arms/her hand was swollen, and her whole arm was like a log, it has been very uncomfortable; Her arm is very, very sore at the site of injection/Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; Her joints in her elbows, wrists, and ankles are hurting/lot of joint pain; Nauseous; lymph nodes were affected and swelling; Tired; Swelling everywhere; Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; uncomfortable; This is a spontaneous report from Social Media by a contactable consumer (patient). A female patient of 74-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via unspecified route of administration in right arm on 05Feb2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included chronic kidney disease from an unknown date in 2012. The concomitant medication was not reported. The patient stated that have not had any other recent vaccinations or started any new medications. The patient reported that on an unknown date Feb2021, soreness in arms, she has had swelling in her calves, her left and right arms. She said her arm is very, very sore at the site of injection, her breasts are very sensitive and sore, nauseous and later went away, had a lot of joint pain and swelling everywhere, her lymph nodes were affected and swelling, her right arm where vaccine was given her elbow was still swollen and sore below injection and also specified that swelling where arm is connected to elbow. It was also reported that hand was swollen, and her whole arm was like a log, it has been very uncomfortable on an unknown date in Feb2021. The patient has been tired on an unknown date in Feb2021 and patient worried about recovery of events. The patient stated that lymph nodes took 2-3 days, which started Sunday (as reported). It was reported that patient was still in sore, the breasts are super sensitive, which was weird. The patient also had strange shooting pains in her right arm that are shooting through it. The patient left arm was sore, but not as sore as her right. She said her knuckles were cracking when her hands move, and her right wrist was very sore but that was not so bad now. The patient stated that she thought these events were due to her good immune system. The joints were still sore, her elbows, all of the upper part of her body were also sore. The patient also reported that she was told older people don't have much reactions, but she certainly had. The patient had not seen doctor for the events. The patient took acetaminophen (LOT M045G, EXP Dec2023) as a treatment medication for the events. The outcome of the events nauseous was recovered on an unknown date in Feb2021, for the events swelling everywhere, uncomfortable, tired, lymph nodes were affected and swelling, breasts are sensitive/her breasts are very sensitive and sore was unknown while for rest of the events was not recovered
74 2021-03-18 pain in extremity she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotte... Read more
she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249, Expiration date: May2021), via an unspecified route of administration in left arm 03Feb2021, at 10:50 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Prediabetes (5 years ago) and obviously overweight and had cat bite. The concomitant medication was not reported. The patient previously took historical vaccine, on an unknown date in Jan2021 (she got the first dose three weeks before on a Wednesday), first dose of bnt162b2 for COVID-19 immunisation and had no reaction. On 03Feb2021 (early evening) the patient experienced a bad headache and was very tired. Caller says where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that. She says she also had muscle aches and pains. The patient took Aspirin (UPC 9629513147, LOT: P115130, EXP: May 2021) for the event muscle aches and pains at a dose of 325mg, one before bed, took three during night total. The patient reported that she slept and slept and slept on an unknown date in Feb2021. It was reported that patient lots of bloodwork done over the years but if she eats correctly it goes away, then if she gets into the sugar, it comes back. The outcome of the events, where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that and she also slept and slept and slept was unknown while for other events was recovered on an unknown date in Feb2021.
74 2021-03-21 pain in extremity Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot.; several SVT &DVT in ... Read more
Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot.; several SVT &DVT in multiple veins & artery of left foot; several SVT &DVT in multiple veins & artery of left foot; Pain & swelling of foot; Pain & swelling of foot; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 12:00 AM (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Some antibiotics cause autoimmune issues, all sulphate drugs, narcotics. Historical vaccine included first dose of Pfizer COVID 19 vaccine (lot_number=EL3249) on 22Jan2021 12:00 AM administered in Right arm. Concomitant medications included thyroid (NATURE THROID) and multiple vitamin, taken for an unspecified indication, start and stop date were not reported. The patient experienced Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot. Pain & swelling of foot, all on 06Mar2021 01:00 AM with outcome of not recovered. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received for events included given Eliquis to avoid further clotting. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
74 2021-03-22 weakness High fever, general weakness leading to fall and hospitalization
74 2021-03-23 weakness Patient received 2nd COVID-19 vaccination on 3/13/21. Manufacturer and lot # of vaccine not availab... Read more
Patient received 2nd COVID-19 vaccination on 3/13/21. Manufacturer and lot # of vaccine not available as administered at outlying clinic/facility. Date of 1st vaccination also unknown. Patient presents to ED after fall. Patient states that she has had significant weakness since receiving 2nd COVID vaccination. Patient states prior to COVID vaccine she was in her normal state of health. Patient troponin was elevated at 0.99. Patient denies any chest pain or shortness of breath. Patient diagnosed with non-STEMI. Treated with medical management including heparin drip and continue aspirin + Plavix + statin therapy. Patient was discharged to rehab facility on 3/18/21.
74 2021-03-28 unresponsive to stimuli Patient reviewed vaccination at 1:20pm. She was observed for one hour per MD. At 5:18, she became un... Read more
Patient reviewed vaccination at 1:20pm. She was observed for one hour per MD. At 5:18, she became unresponsive in her wheelchair and became blue with no palpable pulse. Patient had a DNR status and was not revived.
74 2021-03-30 bell's palsy, numbness Bell's Palsy second occurrence. First occurrence 12/18 Numb toes on both feet
74 2021-03-31 weakness, cold extremities a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the si... Read more
a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the side that she got the vaccine was cold; Second dose: pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2, dose 2, via intramuscular, administered in right arm on 16Mar2021 10:00 AM (Lot Number: EN6204; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included eczema from 2017, she had eczema all over her back and arms and had mild allergies to mold and juniper. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 at the age of 74-year-old on 23Feb2021 at 10:00AM (lot number: EN6198, Expiry: Jun2021) intramuscular injection in left arm and experienced pain at injection site and couldn't sleep. The patient also took Prolia shots for arthritis. The patient experienced headache, nausea, pain at injection site and hand on the side that she got the vaccine was cold on 16Mar2021, passed out, weakness and disorientation when walking on 17Mar2021, a little tired on 18Mar2021. The clinical course included: The patient was calling about the second vaccine that she got on 16Mar2021 (Tuesday). She was calling about the after effects. They were quite huge. She had a headache, nausea, weakness, and disorientation when walking. Stated she obviously had pain at the site of injection. Stated some of it was her own fault, and at first she felt fine. On the same day that she got her second dose of the covid vaccine, she had a glass of wine and was not too hungry. She ate a little that evening. The next morning she passed out. Clarified that she had two glasses of wine, not one. Caller's daughter was a doctor. Caller referd to her daughter as doctor daughter. Stated that she told her daughter about what happened. Her daughter told her it was because she was dehydrated. Her daughter told her that it was called vagus something or another. Her daughter was not there with the caller. Her daughter called it vagus something, she does not remember. Her daughter told her that it had to do with inflammation and her immune system. Caller stated she also has arthritis. Her daughter told her that she was stupid for drinking wine after receiving the second dose of the covid vaccine and not eating a full meal. Whenever she passed out and fell, she did not hurt herself but it was a wake up call. She realized she was vulnerable. She was calling because she did not know why no one told her to drink a lot of water after receiving the vaccine. She got a Prolia shot in July and the nurses told her to drink a lot of water. She was asking why the nurses who gave her the covid vaccine are not saying that to people. Her daughter told her to call the doctors office about this, and she told her daughter that it was over with now, she's 95%, she was a little tired on 18Mar2021. She was unconscious for 15 seconds per her husband. Her husband was shouting her name, and she did not hear anything. She wanted to call and report that the nurses should tell people to drink water. One more thing, her daughter told her that the covid vaccine was slowly released. About 10 hours after receiving the second dose of the covid vaccine her hand on the side that she got the vaccine was cold. She got the vaccine about 10AM, and about 10PM at night is whenever her hand got cold. She had pain at the injection site where she had the first dose of the vaccine too. She had more pain at injection site after the second dose of the vaccine. It was not awful, but only if she pressed on it. Clarified that she gets Prolia shots twice a year for her arthritis. Luckily whenever she started to get dizzy, she braced her self, whenever she fell, she did not fall from an upright position. She was crouched over, and fell against trays that fell with her. Her doctor daughter told her that inflammation was because of her immune system. One other thing was that she has been stung in the past and had extreme reactions from yellow jackets in the 90's. She thought her immune system was sensitive. One other things related to her autoimmune from 3 years ago. She moved to a city in 2012. Everyone told her after 5 years she would develop allergies. In 2017, she had eczema all over her back and arms. It was not just like a topical thing where she scratched and itched, it was under her skin. She went to a dermatologist and he took a biopsy, but the results just said eczema. She went to an allergist, he finally found a space on her underarms where he could do a test. The test showed that she had mild allergies to mold and juniper. Juniper is a tree that they have there, she has one in her back yard. Her allergy was very mild. She tried everything, and in 4 months it went away. Now she just latherers her skin with coconut oil. Her diagnosis that this autoimmune issue was related her immune response from the yellow jacket reaction is a self diagnosis. A doctor had never told her this, this was coming from her own self. Clarified that she is calling about the second dose of the pfizer covid 19 vaccine. Headache: It was not a bad headache, it was more like pressure all across the top. Whenever she went to sleep, the headache started. She got the second dose of the covid vaccine on 16Mar2021. She had a little bit of a headache this morning. A cup of coffee with milk made it better. Nausea: It started whenever she did not want to eat dinner. She could tell her stomach was not right. The nausea and headache started together about 12 hours after her vaccine at 10:00 PM. Weakness: She noticed weakness on the next day whenever she got up to use the bathroom. Clarified as the early morning of 17Mar2021. Her weakness was about 90 percent resolved. Disorientation when walking: Clarified that her disorientation was in reference to walking only right before she fell. She was not mentally disoriented. Mentally she knew that she was not doing well. Second dose: pain at injection site: The pain only lasted for about 2-3 hours. It was now absolutely minimal. She would have to press on it to feel anything. Her hand on the side that she got the vaccine was cold: She got the second dose of the covid vaccine around 10:00 AM, and noticed her hand was cold about 5:00 PM., about 7-8 hours later. Whenever she went to bed, she was cold. She thought that it resolved by the next morning. The morning after receiving the second dose of the covid vaccine, she passed out: She passed out about 8:15 AM. The outcome of the events headache, nausea, weakness, pain at injection site was recovering. The outcome of the events disorientation when walking and her hand on the side that she got the vaccine was cold was recovered on 17Mar2021. The outcome of the other events was unknown.
74 2021-04-01 unresponsive to stimuli, seizure DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cardiac arrest (HCC) [I46.9] HOSPITAL COURSE: Patien... Read more
DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cardiac arrest (HCC) [I46.9] HOSPITAL COURSE: Patient is a 74 year old female who receives care through healthcare clinic and second healthcare clinic with past medical history of HTN, CKD, cardiomyopathy/congestive heart failure, atrial fibrillation on Pradaxa who presented to the ED 3/16 after suffering an out of hospital cardiac arrest at her dentist's office. Per report, patient had SBP in the 80s on arrival but was asymptomatic. Prior to start of any procedure (no reports of being given sedative medications), she became unresponsive. CPR was initiated and was found to be in asystole. She received 3 rounds of CPR with ROSC. CT head without acute abnormality. Chest XR showing mild vascular congestion and interstitial edema. Initial labs showing AKI, elevated liver enzymes, BNP >29,000, troponin 39, lactic acid of 11, INR of 6.6, PTT 62, APTT 87. UA with protein, nitrite, moderate blood. Urine culture ordered. Blood cultures ordered. In ED, patient was hypotensive requiring addition of vasopressors. Targeted temperature management was started. Ceftriaxone and flagyl started for possible urinary tract infection and aspiration. Patient with profound coagulopathy, INR increasing to 12.0 on arrival to the ICU. Two units FFP and vitamin K were given. Patient with escalating pressor requirements at this time so CT t/a/p was ordered showing multiple bilateral rib fractures, nondisplaced sternal fracture with small anterior mediastinal retrosternal hematoma, small right sided hemothorax, right chest wall hematoma, patchy bilateral airspace disease consistent with atelectasis/infiltrate/aspiration, diffuse GGO consistent with interstitial edema, enlarged pulmonary arteries consistent with pulmonary hypertension, cholelithiasis. FDP elevated and 2 units of cryoprecipitate given 3/16. Hemoglobin decreased to 5.9 3/17 with INR of 5.4. Two additional units of FFP and additional dose of vitamin K ordered. Two units RBCs ordered. CTA thorax and abdomen 3/17 re-confirmed hemothorax and chest wall hematoma but no active bleeding noted. CT bilateral LE showed no evidence of hematoma. Trauma consulted who recommended chest tube placement. Overnight 3/16-3/17, patient also noted to have seizure activity on EEG and patient loaded with Keppra. Head CT 3/17 negative for hemorrhage or other acute processes. Patient remained in status epilepticus 3/17am and additional Keppra load was given and neurology consulted. Received Praxbind for continued bleeding/coagulopathy. 3/17pm went into PEA arrest with 10 minutes of CPR with ROSC. Bronchoscopy following ROSC noted evidence of bleeding from multiple areas, clots removed. MRI brain showing diffuse anoxic brain injury. Propofol stopped 3/19am. After goals of care discussion this morning, all first degree relatives (daughter and son) all in agreement to transition to comfort care measures. I received call from bedside RN that patient had passed away. On exam, no heart or breath sounds appreciated upon auscultation for 2 minutes. No spontaneous movement or chest rise noted. No pulse palpated for two minutes. Pupils fixed and dilated. No response to noxious stimuli. Time of death 1400 3/20/2021.
74 2021-04-01 tremor, weakness weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated p... Read more
weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated prior to this admit; shaking; chills; severe headache; right mid and low back pain; high fever up to 103 degrees; Not able to get out of bed except to get to nearby bathroom; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 74-years-old via an unspecified route of administration, administered in arm left on 05Mar2021 15:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included anal cancer (h/o anal cancers/p chemo & RT2013), hypertension, hypothyroidism and new fe deficiency anemia dx during this admit from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient has known allergies to Ampicillin, clindamycin, trilafon, imipramine. The patient reported that 4.5 days after 1st dose of Pfizer vaccine on morning of 10Mar2021 09:00, the patient woke up with shaking chills, severe headache, right mid and low back pain, high fever up to 103 degrees within 1/2 hr of onset and not able to get out of bed except to get to nearby bathroom to use toilet when needed. The patient took Tylenol 500 mg up to 5 doses by 10:00 am of 11Mar2021 when fever would not abate; the patient was weak and lightheaded on an unspecified date and since lived alone called a number to take her to ER. On an unspecified date, her blood pressure was low 80's to 90's over 40's to 50's all thru night and 1000 more mg of Tylenol was given at 4:00 am and fever then lowered to 99 or 100. Full infectious work up negative for bacterial sources including abdominal and pelvic cat scan, abdominal ultrasound, CXR, urine culture, she received 2 1/2 liters of IV fluid and IV Ceftriaxone and Flagyl in ER. In case bacterial cause which was not found including blood cultures, due to her BP still not improved by 5:00 am as she was dehydrated prior to this admit, she was admitted on medicine floor for 2 days. The patient underwent lab tests and procedures which included abdomen scan: unknown result on an unspecified date, blood pressure measurement: low 80's to 90's over 40's to 50's all thru night on an unspecified date; still not improved on an unspecified date, body temperature: high fever up to 103 degrees on 10Mar2021; 99 or 100 on an unspecified date, chest x-ray: unknown result on an unspecified date, culture urine: unknown result on an unspecified date, sars-cov-2 test: negative on 10Mar2021, ultrasound abdomen: unknown result on an unspecified date. Therapeutic measures were taken as a result of the events which included IV, fluids, 1 dose of 2 different IV antibiotics (Ceftriaxone and Flagyl) and Tylenol. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
74 2021-04-06 weakness her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fl... Read more
her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fluids/I was so dehydrated; hadn't eaten anything; stated she started salivating and then threw up; stated she threw up once; she had a severe headache; she was shivering all evening and she couldn't get warm; she had body aches; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249, NDC number: Unknown, Expiration Date: May2021, Manufacturer: Unspecified) via an unspecified route of administration at right arm on 15Jan2021 at single dose for COVID-19 immunisation. Medical history of patient included knee pain and anxiety. Patient's concomitant medications included tramadol, paracetamol both 500 mg for knee pain and hydroxyzine hydrochloride (25mg tablet up to three times a day as needed by mouth, she does not take every day) for anxiety. On 15Jan2021 after vaccination patient experienced salivating and then threw up, stated she threw up once, severe headache, shivering all evening and she couldn't get warm, body aches, nausea, lost a lot of fluids/I was so dehydrated, hadn't eaten anything and her blood pressure was very low the next morning, she felt really weak on 16Jan2021. She required urgent care trip for IV fluids, "She was so dehydrated" and was "miserable" with her symptoms. She said she lost a lot of fluids and hadn't eaten anything. Patient wants to get the second COVID-19 vaccine dose because she is scheduled to have a knee replacement on 26Feb2021. She said she also had to deal with the pain in her knee, clarifying that is why she is getting a knee replacement. IV fluids (clarified as Saline), tylenol given as treatment. She reported when she got home she drank Pedialyte to try to rehydrate herself. She reported she went to urgent care on Saturday (16Jan2021), and by Monday 18Jan2021, she was feeling better, but she didn't golf on Tuesday, 19Jan2021. patient underwent lab tests and procedures which included blood pressure measurement which very low, influenza virus test and sars-cov-2 test was negative on 16Jan2021, blood test was fine. Patient said yes for investigation assessment. The outcome of event was recovered on 15Jan2021 for Increased salivation and Vomited and for all other event outcome was recovered on Jan2021.
74 2021-04-07 tingling Patient presented to ER with R back pain paresthesia. CTA performed:Segmental and subsegmental pulm... Read more
Patient presented to ER with R back pain paresthesia. CTA performed:Segmental and subsegmental pulmonary emboli involving the left upper lobe.
74 2021-04-07 unresponsive to stimuli Patient was vaccinated on 4/6/21 at 9:05 am. Report received that patient was in the car on the way... Read more
Patient was vaccinated on 4/6/21 at 9:05 am. Report received that patient was in the car on the way home from the vaccination and had chest pain and shortness of breath. Patient called their primary care doctor who requested reporting to the nearest emergency room immediately. Patient became unresponsive in the car. Patient arrived in cardiac arrest (arrival time noted to be 4/6/21 at 10:54 am, CPR began. Patient was intubated in the ER, and received epinephrine, amiodarone, and was defibrillated several times per ACLS protocol. Patient did not have return of spontaneous circulation and was subsequently pronounced. Per report, it was noted that patient was short of breath prior to receiving vaccination earlier in the day.
74 2021-04-09 pain in extremity elevated CPK; Unable to raise arm; arm became sore; Muscle trauma/ some kind of damage either to hea... Read more
elevated CPK; Unable to raise arm; arm became sore; Muscle trauma/ some kind of damage either to heart muscles to the brain or some skeletal muscle on the body; Muscle trauma/ some kind of damage either to heart muscles to the brain or some skeletal muscle on the body; This is a spontaneous report from a contactable nurse reported for herself. A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EP7534, expiration date: 31Jul2021, via an unspecified route of administration, administered in left deltoid (also reported as left arm) on 21Mar2021 at a single dose for COVID-19 immunisation; and rosuvastatin calcium, oral from an unspecified date (Lot Number: 20082811; Expiration Date: Jul2022) to an unspecified date, at 5mg every night for hyperlipidemia and Stage 3 kidney disease. Medical history included hypertension (diagnosed maybe 30 years ago, it is controlled), status ventricular tachycardia in 2001 (controlled), stroke (suffer stroke may be 12 or 13 years ago without the residual), Phase 3 renal disease/Stage 3 Kidney Disease, extracted tooth, bad tooth, aches and pain in her legs in Jan2020 and ongoing, and muscle pain. Patient did suffer stroke may be 12 or 13 years ago without the residual, it was incidental finding with the MRI with the brain because she had a bad tooth and they extracted the tooth, they decided to complain let's do a brain MRI of the brain and it showed an influx in right cerebellum but without residual she have no deficit, but they put her on Plavix first but the bruising was very severe so they changed it to Aggrenox which she successfully use Aggrenox now. Other medical conditions: Consumer stated, Folic acid, sodium bicarbonate, yes the Soda Bicarb (sodium bicarbonate) is for the Phase 3 renal disease but numbers are good, my DE creatinine all was normal but my nephrologist who happened to be a friend of mine said stage 3 renal disease. Concomitant medications included acetylsalicylic acid, dipyridamole (AGGRENOX) taken for antiplatelet therapy, and paracetamol (TYLENOL) taken for pain. Concomitant medication: Consumer stated, "I take lots of medication, I mean I take Tylenol but none these have a direct correlation to the, I take Aggrenox, Aggrenox is antiplatelet, oh you are a pharmacist so you know that, that's Persantin and aspirin that's the combo, its antiplatelet." Patient has no additional vaccines administered on same date of the Pfizer suspect. Patient previously took clopidogrel bisulfate (PLAVIX) and experienced bruising; folic acid, and Soda Bicarb (sodium bicarbonate) for phase 3 renal disease. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6203, expiry date: 30Jun2021, on 28Feb2021 for COVID-19 immunization. It was given in her left arm. She received the second dose of the Covid-19 vaccine on Sunday (21Mar2021). Her arm became sore on 21Mar2021. On Wednesday (24Mar2021), she was unable to raise her arm even in the shower. She saw her doctor on Thursday because she is on a statin and had aches and pain in her legs. They drew blood and found that she has an elevated CPK on 26Mar2021. It is not grossly but is elevated and has had muscle trauma. Could there be a connection? She reduced the statin to three times a week. The arm soreness is 30-40% improved. She can move her arm away from her body. It felt like she hit her elbow in the funny bone. It was an odd feeling down to her fingertips. The vaccine card indicates the vaccine was given in her right deltoid but it was given in her left deltoid (Left arm). She clarified that she is taking Rosuvastatin Calcium instead of Crestor. She added that she has Stage 3 Kidney Disease. The Nephrologist had told her that she needed to take Rosuvastatin Calcium 7 days a week instead of three. She has only had the pain since she started taking it daily. She stopped taking it daily this past Monday night. She told her doctor she will be taking it only on Monday, Wednesday and Friday. Consumer further stated, she had a very sore arm that she cannot lift over her hand, it feels like somebody hit her elbow. Consumer further reported and stated that she had the Pfizer second vaccine on Sunday (21Mar2021), by Wednesday (24Mar2021), she could not lift her arm, she went to her doctor yesterday and she was a nurse for 54 years so she did not think that was big deal, vaccine do give you a sore arm. However, she drew blood, well she didn't, the technician drew blood in that arm and her CPK is elevated, Patient stated "am I speaking to a pharmacist, doctor or, okay CPK indicated some kind of damage either to heart muscles to the brain or some skeletal muscle on the body. Mine has never been elevated, it's not growth fully elevated like indicative of cardiac event, However, it is elevated so I thought I should report this to Pfizer so I want you to know that, this is unusual finding." She was on a statin drug, she was on Crestor 5 mg once a day (clarified that she is taking Rosuvastatin Calcium instead of Crestor), however she cut it back to just 3 times a week now because her cholesterol numbers are good, my LDL and HDL are all good and the Cholesterol drug (Intent: Crestor) is known to cause this muscle aches and pain but this is so coincidental with this arm, her left arm where she received vaccine and this CPK being elevated and she thought perhaps Pfizer should be made aware. Consumer stated, "I have been a nurse, I am retired now, I am 76 but I had been a nurse for 54 years, I was at one time director of nursing, so I am familiar with the healthcare system and most medications but of course this Pfizer vaccine and Moderna and Johnson and Johnson these are brand new, this is a Covid pandemic so. Causality: Consumer stated, I kind of think there is connection there sir, because remember that it could be, muscle damage that elevates your CPK, it could be cardiac muscle, it could be a stroke, neither which I didn't have a heart attack. I was having a lot of muscle pain, prior because of the Crestor but that is the common side effect of any statin drug can cause muscle aches and pains. However, I thought there was quite a connection getting the vaccine in the right arm, not being able to raise my (incomplete sentence) now vaccine was Sunday which was I believe the 21st and this event did not happen until, I was sore Sunday evening but the unable to raise it was Wednesday, which was 3 days later yeah and the blood draw was yesterday morning and this morning my doctor called me to tell me that my CPK was elevated not grossly but enough to make the phone call. Consumer stated, the first one was on 28Feb2021 and the lot number was EN620, I need my magnify glass, there is one right here because it's so small, okay its EN62C or is it 0, it's hard to tell 3 is the last number. The second dose with lot number is EP7534. Consumer stated, Let me just look at the calendar to make sure that was Wednesday, I got the shot on 21st, yes sir, it was the 24th, the arm was sore even that evening the 21st (21Mar2021), evening of the 21st but the inability to move it was Wednesday the 24th, I could not move even move it away from my body so I was guarding it, today it's not as bad, I can move it but I still feel it like up in my shoulder. When confirmed if the event has improved, consumer stated, I would say yes but not totally gone. Consumer stated, I just took Tylenol that's all, I mean what I was going to do, I think I took, I know I took a shower last night Wednesday at night, I might let the warm water run on it, I might have, I don't remember, I took a shower regardless so." Lab test: Consumer stated, "I had blood work yesterday all my values were normal, Cholesterol was normal the only thing that was elevated was the CPK." Consumer stated, "I thought that it was necessary to report it okay, is there any way you can tell me is this a common occurrence where CPK elevates slightly." The action taken in response to the events for BNT162B2 was not applicable and for rosuvastatin calcium was dose reduced. The outcome of the events 'arm became sore, unable to raise arm, elevated CPK and muscle trauma (muscle injury)' was recovering while the outcome of the other event was unknown. The reporter considered the events 'arm soreness, unable to raise arm and elevated CPK' as serious (medically significant). The causality of the events 'arm soreness and unable to raise arm' was related to BNT162B2, and event 'elevated CPK' was related to rosuvastatin calcium.; Sender's Comments: Based on a drug event temporal association, the company cannot completely rule out a reasonable possibility that BNT162B2 caused the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
74 2021-04-12 weakness Two days after receiving vaccine patient and family reports patient developed nausea and headache. s... Read more
Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report.
74 2021-04-23 pain in extremity Asthmatic bronchitis; Arm soreness; This is a spontaneous report from a contactable Consumer (Patien... Read more
Asthmatic bronchitis; Arm soreness; This is a spontaneous report from a contactable Consumer (Patient) via Pfizer-sponsored program. A 74-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date were unknown,) via unspecified route of administration, on 02Feb2021 (age at vaccination 74-years-old) at single dose for COVID-19 immunization. Patient had asthma before first shot but it was unclear if she was having more trouble now. The patient concomitant medication was not reported. The patient was scheduled for the second dose on 24Feb2021. The patient went to her pulmonologist for regular scheduled appointment for asthma who prescribed her prednisone and an inhaled steroid for her asthmatic bronchitis. The patient does not want to jeopardize the effectiveness of the vaccine so she was wondering if there may be any potential interactions between the steroids and the vaccine. The patient also stated that she had arm soreness for 1.5 days after the vaccine. Patient wanted to know if there was any information regarding the vaccine for patients with osteoporosis. Patient heard that there could be more symptoms/side effects from second dose of the vaccine. No PQC was present. Patient asked if she can have Prolia shot in between the 2 doses or she needs to delay. The outcome of the events was unknown. Information on the lot/batch number has been requested.
74 2021-04-24 migraine, one side paralysis Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache ... Read more
Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache like migraine/chronic migraine; symptoms of a stroke; weakness on my right side from tongue to nose; weakness on my right side from tongue to nose; extreme nausea; general malaise; My shot arm feel like felt like I had been hit for several days; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) via an unspecified route of administration on 09Feb2021 at age of 74-year-old at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 19Jan2021 at age of 74-year-old for COVID-19 Immunization, the patient had no soreness or reaction until 10days later on 29Jan2021 when she had a low fever ~0.5-1 degree with chills and aches like a fever for 3 days, the patient experienced aches and pain; hurting all over on 29Jan2021, the patient took no medications, there were no further reaction. The second shot given on 09Feb2021, the patient's shot arm felt like she had been hit for several days beginning 10Feb2021. On 11Feb2021, the patient got a severe headache like migraine. Pain level 10/10. She had chronic migraine with all symptoms of a stroke (extreme nausea and weakness on her right side from tongue to nose, extreme headache about left side of the head). The headache on 11Feb2021 was overlap headache. On both sides of head and nausea. No other migraine symptoms. It lasted for 3 days. The patient was hospitalized due to the event(s) headache like my head was going to explode/severe headache like migraine/ chronic migraine. The patient took only butalbital, caffeine, paracetamol (FIORICET, 50, 325-40) from 11Feb2021 to 12Feb2021 at 40mg caff for several headache like migraine; promethazine (PHENERGAN) from 11Feb2021 to 12Feb2021 at 25mg for several nausea. The patient had several events general malaise where she didnot feel like doing her thing until today 30Mar2021. She had taken no medications or seen a doctor about it. The outcome of "headache like my head was going to explode/severe headache like migraine/pain level 10/10", "headache like migraine/chronic migraine" was recovered in 2021. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021145090 same patient, same drug, different event, different dose separated in times
74 2021-04-24 facial paralysis TIAs; Face, from the nose down looked like teeth were melting; so disoriented, she didn't know where... Read more
TIAs; Face, from the nose down looked like teeth were melting; so disoriented, she didn't know where she was, she didn't feel like herself; since this happened she makes mistakes; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the upper right arm on 06Mar2021 at 17:30 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus diagnosed in 1998-1999, high blood pressure diagnosed about 3 years later from Diabetes Type 2, like 2002 and little bit obesity. The patient family medical history included that her mother passed in 2008 and was admitted to hospital where she had TIA maybe in 2005. The patient's concomitant medications were not reported. The patient was not administered additional vaccine on same date as suspect vaccine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient family medical history included that her mother passed in 2008 and was admitted to hospital where she had TIA maybe in 2005. On 19Mar2021, the patient woke up so disoriented, she didn't know where she was, she didn't feel like herself, felt weird. She was staring out the window, and she daughter called her on the phone and caller told daughter she was feeling crazy, that morning was feeling weird and her daughter informed it was not morning it was in the evening and patient did not sound right. The patient's face from the nose down, looked like her teeth were melting, both cheeks looked like they were melting. She said her bottom lip was turned out and down, sagging, drooping. On 19Mar2021, about 18:30, the patient went to emergency room and was admitted to the hospital on 19Mar2021 around 21:00-22:00. On 19Mar2021 around 21:00-11:00, while she was in the hospital, her sugar had gone up to 310, hard time bringing her sugar down and blood pressure was way up, way higher than normal. In the hospital the patient was told she had transient ischaemic attack (TIA). The patient was discharged on 21Mar2021. The patient informed that since it happened she was making mistakes. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EP6955) via an unspecified route of administration in the upper right arm on 27Mar2021 as single dose for COVID-19 immunization. The informed that the she waited until after she received her second dose to inform about the events just in case something else happened. She stated she was fine now, everything was ok and stated she did believe the events were related to the vaccine. The patient followed up with her primary doctor, talked to him about her experience and going into the hospital. He instructed her to call Pfizer and let them know of her experiences. The patient underwent lab tests and procedures which included Computerised tomogram scan, Magnetic resonance imaging on unspecified date in Mar2021 and sugar 310 and hard to bring down, blood pressure was way up on 19Mar2021. The outcome of event since it happened she made mistake was unknown and rest all events was recovered on an unspecified date 2021.
74 2021-04-26 pain in extremity chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness... Read more
chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness to my heart; She also had tenderness in muscle where site of vaccine was; headache; Left arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation (Age at vaccination 74 years) . Medical history included atrial fibrillation from 2019 (AFib was diagnosed a couple of months before Dec2019) , chronic obstructive pulmonary disease from Dec2019 , medical device implantation (Watchman device inserted), anaemia , oesophagogastroduodenoscopy , oesophageal stenosis, obesity. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) from Jul2019 to an unspecified stop date; metoprolol (METOPROLOL) taken for heart rate irregular from Nov2019 to an unspecified stop date. The patient previously took bnt162b2 for covid-19 immunisation on 06Jan2021. The patient also took aspirin (E.C.) and experienced haemorrhage. The patient experienced feeling occasional pain and tightness to my heart on 30Jan2021 with outcome of not recovered , chest pain on an unspecified date with outcome of not recovered , she also had tenderness in muscle where site of vaccine was on 28Jan2021 with outcome of recovering , headache on 28Jan2021 with outcome of recovering , left arm pain on 28Jan2021 with outcome of recovered. No follow-up attempts are possible. No further information is expected.
74 2021-04-26 tremor troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her h... Read more
troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her head and her back; Chills; fever; She was shaking badly; Fainted; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 11:15 (Lot Number: ER8727; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 74 years). Medical history included ongoing rheumatoid arthritis, melanoma, depression, heart attack (had a heart attack 7 or 8 years ago) and covid (covid in the first week of January). Concomitant medications included levothyroxine sodium (SYNTHROID) and escitalopram oxalate (LEXAPRO) for depression. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for covid-19 immunisation and experienced rash with itching and a lump and swelling (74 years). The patient fainted on 24Mar2021, chills and fever on 24Mar2021 20:00, pain on the back of her head and her back and a couple of places like anyone would get when they fall on 25Mar2021 and she was shaking badly on 24Mar2021. The patient underwent lab tests and procedures which included blood work: unknown results and troponin: high troponin levels on an unspecified date. Therapeutic measures were taken as a result of tremor included Aleve. Outcome of the events chills and pyrexia was recovered on 25Mar2021 (four hours) while outcome of the events head pain and back pain was recovering. Outcome of the remaining events was unknown.
74 2021-04-27 weakness couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed; couldn't con... Read more
couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed; couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed; labored breathing / Breathing difficult; swelling face; swelling face, mouth, tongue/my skull was swelling; swelling face, mouth, tongue/my skull was swelling; swelling face, mouth, tongue/my skull was swelling; Dizzy; weak; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot ER8727, second dose) solution for injection intramuscular in the left arm on 22Mar2021 at 09:00 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: sulfa drugs. There were no concomitant medications. Historical vaccine included BNT162B2 (first dose, lot EN6198) for COVID-19 vaccination on 01Mar2021 and experienced nausea, dizzy, weak, feeling unwell, and sore arm at injection site. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Mar2021 at 09:30, the patient experienced labored breathing, swelling face, mouth, tongue/my skull was swelling, out of breath with little exertion, dizzy, and weak. On 23Mar2021, the patient couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed. The events resulted in emergency room/department or urgent care. Treatment for the events included EPIPEN, steroids, ZYRTEC, famotidine. The outcome of the events was recovering. The patient was not test for COVID post vaccination.
74 2021-04-27 unresponsive to stimuli post-cardiac arrest; collapsed; initial rhythm was PEA; unresponsive; This is a spontaneous report r... Read more
post-cardiac arrest; collapsed; initial rhythm was PEA; unresponsive; This is a spontaneous report received from a contactable pharmacist. A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 20Apr2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. It was reported that patient was not pregnant. Facility type vaccine was reported as unknown. The patient's medical history included acute respiratory failure with hypoxia, cardiac arrest, transaminitis, and diabetes. It was unknown if patient had COVID prior vaccination. The patient's concomitant medications were not reported. It was unknown if patient received other medications in two weeks and if she received any other vaccine in four weeks. The patient previously received first dose of BNT162B2 on unspecified date at single dose for COVID-19 immunisation, lisinopril and hydrochlorothiazide/triamterene (DYAZIDE) both reported as known allergies. It was reported that patient was brought in by emergency medical services (EMS) status post-cardiac arrest. Per EMS she was driving to urgent care (unclear why). She just got her second Pfizer vaccine. At urgent care she collapsed and cardiopulmonary resuscitation (CPR) was initiated immediately. EMS arrived and her initial rhythm was pulseless electrical activity (PEA). They placed a gel and administered 3 rounds of CPR with 3 onset epinephrine. No shockable rhythm. Patient arrived at hospital intubated and unresponsive on 20Apr2021. Duration of hospitalization was reported as two days. The events were reported as serious with criteria hospitalization and life-threatening illness (immediate risk of death from the event). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if patient was tested for COVID post-vaccination. The outcome of the events was resolving Information on lot number/batch number has been requested.; Sender's Comments: The reported events would seem unlikely related to suspect vaccine BNT162B2, but more likely due to underlying cardiovascular morbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
75 2021-01-05 tingling Patient reported tingling in her right fingers but reported to Heather that she was fine as of 3:06... Read more
Patient reported tingling in her right fingers but reported to Heather that she was fine as of 3:06pm
75 2021-01-10 pain in extremity Extreme pain in bone, not muscle, of left arm started approximately 30 minutes after injection. 4 ... Read more
Extreme pain in bone, not muscle, of left arm started approximately 30 minutes after injection. 4 hours later chills started . Both symptoms continue 12 days later.
75 2021-01-10 pain in extremity Her arm is a little sore; the tissue paper is red after wiping her anal area/ reddish looking poop/ ... Read more
Her arm is a little sore; the tissue paper is red after wiping her anal area/ reddish looking poop/ there are pieces of blood or something is different; This is a spontaneous report from a contactable other Health Professional (patient). A 75-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization, also reported as for work. Medical history included ulcer (15 to 20 years before 06Jan2021). Concomitant medication included prasugrel from Apr2020 and ongoing as blood thinner, acetylsalicylic acid, ascorbic acid (ASPIRIN) from Apr2020 and ongoing as blood thinner. The patient went to the bathroom in the morning 06Jan2021, she had to poop. When she wiped, it was reddish looking. The patient stated her stool color was normal, but the tissue paper is red after wiping her anal area. At first she thought hm oh well. Then she had been to the bathroom a couple of times 06Jan2021, and that the same thing happened. She had never experienced that before. It seems to her that there were pieces of blood or something was different. She wasn't hurting or anything. She was not weak or anything at this time. Her arm was a little sore, but she expected that. She was concerned about the color. She worked in the mammography department. She didn't have a prescribing doctor. She got it at work. She had noticed a difference of color in her poop. It had been the same all day. The outcome of the reddish poop was not recovered, of sore arm was unknown. The patient asked would the vaccine cause rectal blood upon wiping after defecation?; Sender's Comments: Reported blood in stool is considered intercurrent and unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
75 2021-01-10 pain in extremity Mild arm soreness at site the following day Significant fatigue on the following five days and now ... Read more
Mild arm soreness at site the following day Significant fatigue on the following five days and now Heart palpitations and elevated BP on day four Mild nausea on day five
75 2021-01-11 involuntary muscle movements At 11:40am on 1/8/21, resident appeared catatonic and was just staring at the wall. When on unit, o... Read more
At 11:40am on 1/8/21, resident appeared catatonic and was just staring at the wall. When on unit, observed resident seated in a chair, blankly staring at the wall with no loss of consciousness. Blank stare accompanied with mild jerky movement. Resident was safely assisted to bed. Oxygen at 3lpm was administered. Petit mal- like seizure lasted for 5 minutes. Resident regained prior level of alertness and doesn't recall what had happened. Resident with no known history of seizure disorder.
75 2021-01-13 weakness Feels a little weaker/ a little weak like after the Flu shot; Feels a little weaker/ a little weak l... Read more
Feels a little weaker/ a little weak like after the Flu shot; Feels a little weaker/ a little weak like after the Flu shot; This is a spontaneous report from a contactable nurse (patient). A 75-years-old female patient received the second dose of of BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/lot number: EK5730), via an unspecified route of administration on 06Jan2021 at 0.3 mL single (reported as 0.3cc injection) for covid-19 immunization (reported as works with COVID patients on daily basis). Medical history included hypertension, hip replacement from an accident four years before 07Jan2021 in December (Dec2016). The patient was not overweight, exercises, was older, but considered in good health. The had labs in Dec2020 and everything was ok. The patient's concomitant medications were not reported. The past vaccine event included weak after the Flu shot and first dose BNT162B2 on 16Dec2020 (75-years-old) and experienced dental implants and bridge fell out, bones were hurting her, pain in hip. It was reported on 06Jan2021 1PM (06Jan2021 13:00) was kind of weak. And felt a little weaker on 06Jan2021 and 07Jan2021. She did not have a temperature. She wants to know if this only happened to her or if it was a coincidence. She felt ok, but a little weak like after the Flu shot. The event outcome was unknown.
75 2021-01-13 seizure, muscle spasms Patient given vaccine. Within 5 minutes husband said she?s having another spasm. She was being moni... Read more
Patient given vaccine. Within 5 minutes husband said she?s having another spasm. She was being monitored for 15 minutes after the injection. After the spasm it appeared to. become a seizure and passed out for 5 minutes . Husband said she missed her medicine and needed her carbidopa/levodopa. 911 arrived and administered oxygen and took to the hospital.
75 2021-01-13 tenderness, feeling cold after 6 hrs injection of 2nd dose, left arm was swollen felt tender. That night, I feel chilled; n... Read more
after 6 hrs injection of 2nd dose, left arm was swollen felt tender. That night, I feel chilled; not feeling very good. Next day same prblem especially chilled; went to bed under blanket to warm up Its now 12:36 next day, no improvement
75 2021-01-14 tingling Patient reports tingling in Left arm following vaccine administration. Tingling went from site of in... Read more
Patient reports tingling in Left arm following vaccine administration. Tingling went from site of injection down arm to 4th and 5th fingers on left hand. Declines any headache, dizziness, numbness. Can feel touch to hand/fingers
75 2021-01-17 pain in extremity altered taste; altered sense of smell; slight left arm soreness; slight headache; This is a spontane... Read more
altered taste; altered sense of smell; slight left arm soreness; slight headache; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 and expiration date not provided), via an unspecified route of administration left arm first dose on 08Jan2021 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. It was reported that patient got the first shot of the Pfizer Covid 19 vaccine last Friday 08Jan2021. Stated that she had normal slight arm soreness and slight headache on Saturday 09Jan2021. Stated that she woke up this morning 11Jan2021 and had altered taste and sense of smell. Stated that she has not heard of this as reaction to the shot. Stated that she feels fine. Stated that she put on perfume that was old and fixed grits with cheese which she could barely taste. Stated that she tried other things and noticed that she has altered sense of taste and smell. The patient did not received treatments for the events. The outcome of the events slight left arm soreness and slight headache was recovered on 09Jan2021 and not recovered for the other events.
75 2021-01-19 flushing Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbea... Read more
Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbeat and because of her previous history of reaction to chemicals she became anxious. Pt further evaluated by NP and pt c/o itching to back of throat. No SOB. At time of NP evaluation heart rate within normal limit, 84. Alert and oriented. No acute distress. Pt very anxious. Pt monitored for one hour with no issues or emergent care needed.
75 2021-01-20 flushing 5 min post injection angioedema s begin; flushing, flushing to genital area, progressed to GI, throa... Read more
5 min post injection angioedema s begin; flushing, flushing to genital area, progressed to GI, throat, HA, B/P170 (never this high); eyesight blurred. Systemic w/o urticaria
75 2021-01-20 weakness Nose bleed; Dizziness; it left me little weak; This is a spontaneous report from a contactable consu... Read more
Nose bleed; Dizziness; it left me little weak; This is a spontaneous report from a contactable consumer. This 75-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) at single dose for COVID-19 immunization on 09Jan2021. Relevant history included High blood pressure. Relevant concomitant drugs included Losartan for Blood pressure high, and hydrochlorothiazide. The patient had the first Covid 19 Vaccine on 09Jan2021 and she knew little bit dizziness was normal but she had a nose bleed in the next morning that she could hardly stop, she finally got it stopped it, it left she little weak so she just wanted to report that, she did not know if anyone had ever had that before (Hence, MI was made). Outcome of event Nose bleed was recovered, the outcome of other event was unknown.
75 2021-01-20 tingling Systemic: Tingling in the fingers on the same arm of injection site-Mild
75 2021-01-21 pain in extremity Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe B... Read more
Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe BP, but never had that happen before. I was anxious as I have anxiety disorder! But my face was RED and TIRED looking. I asked staff what wrong. No swelling at that time! 4:40 PM. That nite, my heart started POUNDING HARD all night, not stop. Ativan not help. I slept, weird dreams, wake up and still heart pounding. 8 am --- got up and hands, arms, extremities SWOLLEN!! Heart still pounding, Felt like allergic to MSG or nitrates or preservatives or too much salt. Felt weird.. Not faint-- just weird. Tired from the pounding heart. Not fatigued. I did have sore arm, but it was NOT an issue. My hands, toes were red.
75 2021-01-24 pain in extremity 1/16/21 - left arm pain, tired 1/17/21 -fever blister on lower lip 1/19/21 - pain at Rt upper gum , ... Read more
1/16/21 - left arm pain, tired 1/17/21 -fever blister on lower lip 1/19/21 - pain at Rt upper gum , lesion on gum
75 2021-01-24 pain in extremity I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left... Read more
I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left arm, I couldn't sleep on my left arm due to this soreness. This started the day the soreness started. The following day and up till now I felt very tired and like I needed to take a nap. Due to work I have not been able to nap. On Sunday I noticed I had a fever blister on the right side of face, under my lip by my chin. It looked like a herpes blister. I rarely get them unless there is a serious stressor to my body or if my body is emotionally stressed. Valacyclozir I took 4 of those in the morning and 4 tablets in the evening after noticing them. I put a cream on the blister. On Tuesday or Wednesday 3 or 4 days after the vaccine I felt a pain in my gum by back two teeth, the gums were very painful when I brushed my teeth or put my tongue on it. I went to the dentist Friday the 22nd, however the dentist said it was intraoral herpes that he believes it is looked to the vaccine. Dr. believes the COVID vaccine activated the dormant herpes in my system . He said says it is located over the Greater Palatine Foramen. The herpes on my chin went away. I still feel light sensitivity and fatigued. Dr recommended to see my dermatologist. Either the 22nd or 23rd I had a virutal appointment with my dermatologist. She recommended I take 4 Valacyclozir in the AM and PM. And then 1 day for 10 days. Both doctors recommended not getting the 2nd dose until the herpes vaccine goes away. Once it goes away they suggested taking the Valacyclozir before taking the 2nd dose. I am still not feeling normal. My dentist said he was going to consult a group of dentists to see if any other dentists have seen the correlation between the COVID vaccine and activating the herpes virus. I plan to consult my PCP about if I should delay the 2nd dose.
75 2021-01-24 tremor Patient c/o of feeling shaking and pulse racing. Vitals taken 206/93 P98 sao2 98% on RA. at 4:05PM. ... Read more
Patient c/o of feeling shaking and pulse racing. Vitals taken 206/93 P98 sao2 98% on RA. at 4:05PM. 4:06 PM vitals 209/88 P 94 sao2 99%. Pulse increased to 110 at 4:10 PM. Patient transferred to urgent care via w/c. Patient checked and left with nursing staff for evaluation.
75 2021-01-25 numbness 16:45 reports (L) arm numbness starting @ (L) shoulder extending to (L) hand. EMS notified for evalu... Read more
16:45 reports (L) arm numbness starting @ (L) shoulder extending to (L) hand. EMS notified for evaluation. B/P 190/102. P73, Glucose 109 (2° post prandial) O2 sat 100% Pt. refused transport to local hospital.
75 2021-01-25 feeling hot C/O tongue feeling thick, feels hot and has headache. Given Benadryl 50 mg IM RDM and Epinephrine (... Read more
C/O tongue feeling thick, feels hot and has headache. Given Benadryl 50 mg IM RDM and Epinephrine (1:1000 aq) 0.5ml). No improvement and transported via ambulance to ER. Contacted by RN later and reports treated and released at ER.
75 2021-01-25 tingling Facial tingling BP 160/90 HR 85 Resp 18 trelegy prednisone ventolin
75 2021-01-25 feeling hot Tingling in tongue and heat tongue. No v/s provided
75 2021-01-26 cold sweat, feeling cold On 1/26/21 client went to her exercise class at 5:30am, she became extremely cold, clammy, nauseated... Read more
On 1/26/21 client went to her exercise class at 5:30am, she became extremely cold, clammy, nauseated, and said she couldn't sit up. She called her husband to come and pick her up. She was afebrile. Blood sugar was 86. She said she just wanted to sleep. She sleep most of the day and through the night until 3:30 am today. She woke up and said she feels fine. She said at one point her body felt frozen and she couldn't move at all.
75 2021-01-26 tingling Pt developed left lower lip paresthesia that radiated to L side of face. 911 transfer recommended to... Read more
Pt developed left lower lip paresthesia that radiated to L side of face. 911 transfer recommended to which patient declined. Pt has history of TIA, Stroke, CKD, on gabapentin for facial nerve pain.
75 2021-01-27 feeling cold Dizziness; history included compromised immune status; history included compromised immune status; g... Read more
Dizziness; history included compromised immune status; history included compromised immune status; getting really tired/fatigue; Gets real sweaty; chills; almost passed out at doctor's office; Nausea; Felt cold; Blood in urine; Feeling unwell; Feeling bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686), intramuscular in the left upper arm on 08Jan2021 at 15:45 at 0.3 mL, single for COVID-19 immunization. Medical history included Leighten Plantar Alopecia (hair follicle is an enemy), skin infection (infection in body most of the time, at least on skin), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity, autoimmune disorder (diagnosed 8 months ago). She has lost some height, prior to taking the vaccine and she said it was related to age. There were no concomitant medications. The patient experienced feeling unwell on 10Jan2021; blood in urine on 10Jan2021 at 17:00; nausea at 10:00, chills at 11:00, almost passed out at doctor's office at 10:00, felt cold - all on 11Jan2021; getting really tired/fatigue on 14Jan2021 at 09:30; gets really sweaty on 13Jan2021 at 10:00; and dizziness on unknown date. The patient had the first shot on Friday (08Jan2021). On Sunday (10Jan2021), she started feeling bad. She was feeling good about getting it and had no reaction. She has an autoimmune disorder that made her a little afraid to take, but with all the indications, they said it would be much better for her to take it than to get the COVID virus. Sunday (10Jan2021), she does not feel good. So, she started having blood in urine. She thought she had a UTI and had not had one in 20 years. It felt like that is what she had and with the blood in urine. She just took Tylenol and waited until Monday morning because she does not like sitting in doctor's office. They gave her a cup to give sample and said she didn't need to see provider. They will have it checked and in the meantime call in a prescription. It kept getting worse and worse. She was about to passed out in the doctor's office on 11Jan2021, she got nauseous and almost threw up. She got in the car with her husband and he was trying to get her home. She got chills and got so cold and could not warm her body up. Her husband gave her Phenergan and it kind of knocked her out for a while to ease her nausea. She was thinking of going later today (14Jan2021), when she gets enough energy, to get a COVID test. She does not know if it will give false positive or not. She had chills and now she gets sweaty since 13Jan2021. She took her temperature and she did not have one. She just now got up. It is 10:00. She got up this morning (14Jan2021) and was really tired. She was not sweating this morning. Tiredness is kind of new, and when she talked to the nurse, she sort of felt like maybe it was a reaction to the COVID vaccine, but then she talked to her daughter and she said the symptoms she was having are usually symptoms that occur with second dose of the vaccine. It is not uncommon for people to have symptoms she was having. She wanted to know if she should have a COVID test. If she has had just one shot, would the test give a false positive coming from the COVID. They were asking if patient should take the second dose, and should she continue her UTI medication. Doctor's visit to give urine sample on 11Jan2021 (results: negative for UTI). She did not see a doctor though. They sent sample and prescribed a sulfa based medication for a UTI. She did start feeling a little better and stopped having blood in her urine. She plans to continue it because she does not like to stop taking an antibiotic. She did not have any clue that it was not a UTI until the nurse from her provider's office called to tell her results of urine sample was negative. Outcome of event getting really tired/fatigue was not recovered; events almost passed out at doctor's office, blood in urine, chills, and gets really sweaty was recovering; and unknown for other events.
75 2021-01-28 weakness Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chil... Read more
Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chills for 3 nights fever range from 100 degrees up to 103.8, had nauseau and vomited one day, my face- looked a little swollen and cheeks were pink, was in bed mostly for 13 days. Called My Doctor after about 4 days , he prescribed MethyIIPredisolone 4 mg tablets, seems to bring fever down and stop chills, still feeling really bad, went to Urgent Care and they did Covid Test which was Negative, had virtual call with their doctor , and they prescribed a "Z Pak" Did not stated feeling better until 13 day. When taking Predisone, I started having chest pains, when I only had 4 more pills to take. Had to take 2 Nitro and discontinued Predisone. Still weak and tired.
75 2021-01-31 weakness rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak... Read more
rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak to walk further than the bathroom; This is a spontaneous report from a contactable other hcp. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 09Jan2021 13:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included benazepril (BENAZEPRIL), diltiazem (DILTIAZEM), rivaroxaban (XARELTO) and estrogen/methyl te. The patient previously had the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020. The patient stated, "I woke from sleep about 12 hours later (10Jan2021) with rigors, muscle aches, head ache and pain in my inner ears as well as photophobia and feeling of exhaustion. The rigors had resolved by 8am but other symptoms persisted. I was too weak to walk further than the bathroom. I was able to consume only warm liquids, although I had no nausea, vomiting or diarrhea. Note that since onset post infectious irritable bowel symptoms in February after visiting a city, weeks before the pandemic was recognized, I have had very abnormal but not absent sense of taste and smell, making me wonder whether I was infected in February without the usual symptoms." The patient recovered from rigors on 10Jan2021, outcome of the event weakness was unknown while other events were not recovered.
75 2021-02-02 seizure Approximately 22 hours after vaccination had a seizure. Felt fine up until the seizure occurred. Nev... Read more
Approximately 22 hours after vaccination had a seizure. Felt fine up until the seizure occurred. Never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar.; This is a spontaneous report from a contactable Physician. A 75-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 18Jan2021 19:30 at single dose on left arm for COVID-19 immunization. Medical history included Stroke, diabetes, hypertension, anaphylaxis to bee stings. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included sitagliptin phosphate (JANUVIA), hydrochlorothiazide, telmisartan, rivaroxaban (XARELTO), gabapentin and baclofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to Morphine and experienced Hives. Approximately 22 hours after vaccination the patient had a seizure on 19Jan2021 17:15. She felt fine up until the seizure occurred. She never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar. No treatment was received for the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was resolved. Information on the lot/Batch number has been requested.; Sender's Comments: Based on the time association and previously allergic reactions to bee stings and other drugs, the possible contribution of suspect BNT162B2 to the event seizure cannot be excluded in this elderly patient with multiple medical histories including stroke, diabetes and hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
75 2021-02-03 flushing Doctors reporting the patient developed rapid, shallow breathing with chest heaviness. Patient had f... Read more
Doctors reporting the patient developed rapid, shallow breathing with chest heaviness. Patient had facial flushing with a blood pressure reportedly at 212/90. However, a second opinion from another doctor stated they were unsure if true anaphylaxis. Epi pen was administered LOT 0FM498 and patient left in ambulance to go to ER.
75 2021-02-03 weakness Flu like symptons, aches, weakness,chills
75 2021-02-03 seizure Patient had seizure
75 2021-02-04 flushing Pfizer-BioNTech COVID-19 Vaccine EUA drive thru vaccination clinic - Approximately 50 mins after va... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA drive thru vaccination clinic - Approximately 50 mins after vaccination, pt reports transient sensation of something coming over her, dizziness and short period of tongue swelling, SOB and facial flushing. Pt taken to the ED. Prednisone 40mg po at 1312 and discharge prescription for prednisone 40mg daily x 3 days.
75 2021-02-04 pain in extremity severe arm pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 75-yea... Read more
severe arm pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 09:45 at single dose for Covid-19 immunization. Medical history included high blood pressure; thyroid disease; high cholesterol; prior stroke; prior to vaccination, the patient was diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced severe arm pain and fever on 20Jan2021 14:30. No treatment received for the adverse events. This is a non-serious report. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021.
75 2021-02-04 weakness severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tirednes... Read more
severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a "D", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a "B" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.
75 2021-02-05 pain in extremity Sore arm 2 hours after shot. Took tylenol, went away.
75 2021-02-07 flushing At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left side... Read more
At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left sided neck pain, flush, and sudden left sided headache. Staff was notified EMS crew immediately. B/P 151/83, Also diapheretic. Patient reported not feeling well at all and would like to go to the hospital. Transported to local hospital. for evaluation
75 2021-02-07 weakness accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; ... Read more
accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit. Information on the lot/batch number has been requested.
75 2021-02-08 pain in extremity her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke bet... Read more
her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke between 4 and 6pm. She died within 6 to 7 hours later.
75 2021-02-09 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable physician and consumers reported that ... Read more
Bell's Palsy; This is a spontaneous report from a contactable physician and consumers reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported), via an unspecified route of administration on 09Jan2021 at a single dose for Covid-19 immunization. The vaccine was administered at a nursing home. Medical history included dementia, hyperlipidemia, hypothyroid, and drug allergy to penicillin; all from an unknown date. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took iodine and experienced drug allergy. The patient experienced bell's palsy on 15Jan2021. The reported event was resulted in Emergency room/department or urgent care. No treatment was provided for the event. The outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
75 2021-02-09 flushing Deep red Flush Began in cheeks And spread down to jaw line; This is a spontaneous report from a cont... Read more
Deep red Flush Began in cheeks And spread down to jaw line; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at Left arm on 25Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization. Medical history included Penicillin allergy, no other medical history. Concomitant medication included simvastatin. The patient was not pregnant. The patient developed a deep red flush that started in her cheeks and went down to her jaw line on 25Jan2021 on 14:00. Stated that flush seemed to be abating but if it came back and/or other reactions occur she could go to Emergency Room. She had electrical shocks going down her left side. Stated that she read through everything on fact sheet but did not see that a flush might occur, it had been 8 hours. This was her first shot, had an appointment for three weeks for her second shot. No COVID prior to vaccination, no COVID tested post vaccination. The outcome of the event was recovering.
75 2021-02-09 pain in extremity Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer. A 7... Read more
Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer. A 75-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), intramuscular on 02Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was calling about the Covid-19 vaccine and reported that she had the 2 shots. She said that after both shots, her arm hurt, she felt wiped out, and she had joint pain. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The patient said that after the first vaccine, she had not had knee surgery, but before the second the second vaccine she had knee surgery. The patient clarified that it was a knee replacement on 12Jan2021. The outcome of the events was unknown.
75 2021-02-09 pain in extremity, discomfort Shot was painful. I told the assistant I had never had a shot that hurt that badly. She didn't ev... Read more
Shot was painful. I told the assistant I had never had a shot that hurt that badly. She didn't even acknowledge. After waiting 15 minutes I left with some discomfort but figured my arm will probably be sore for a few days. A couple hours after getting the injection, I couldn't move my left arm without excruciating pain. I'm only assuming she gave me the shot to close to the shoulder joint. It's now Tuesday, February 10, and it is improving with more mobility and not as painful. But, still hurts. Cannot sleep on my left side. I'm concerned about getting the second dosage on February 27 and if this has caused any damage to the joint. So far, I have not seen this side affect listed in any Covid fact sheets.
75 2021-02-09 pain in extremity Slight soreness in arm; This is a spontaneous report from a contactable consumer reporting for herse... Read more
Slight soreness in arm; This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261), via an unspecified route of administration on 22Jan2021 14:45 at single dose for covid-19 immunisation. Medical history included breast cancer from 2016 to 2016. The patient's concomitant medications were not reported. The patient experienced Slight soreness in arm. Outcome of event was unknown.
75 2021-02-09 pain in extremity felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a cont... Read more
felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) intramuscular, on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 75 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) received on 02Jan2021 at single dose. Relevant medical history included COVID-19 last Mar2020 and knee replacement on 12Jan2021. The patient received no concomitant medications. The patient reported she had the 2 shots. After both shots, her arm hurt, she felt wiped out, and she had joint pain. After the second shot, she did run a fever as high as 100. She said that she had the second shot on Friday 22Jan2021 and on Saturday she was wiped out. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The event wiped out had resolved in Jan2021, while outcome of other events was unknown.
75 2021-02-10 weakness Patient became weak, had the chills, and spiked a fever.
75 2021-02-10 numbness, tingling tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not i... Read more
tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not in her throat but it was on her neck behind her ear; blood pressure spiked; tired; she didn't sleep well; Chest pain; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: lot number: E19262, via an unspecified route of administration, left arm, on 26Jan2021 10:00 at a single dose to not get Covid and to protect others around her. Medical history included mini stroke at least 8-10 years ago and neuropathy in face from ministroke. Concomitant medication included gabapentin for neuropathy in face from ministroke. The patient had no prior vaccinations (within 4 weeks). The patient previously took pregabalin (LYRICA): but was changed to gabapentin. On 26Jan2021, the patient experienced tingling of lip and face, numbness on left side of face, blood pressure spiked and chest pain. On 27Jan2021, the patient experienced tired. The events were described as: After getting the vaccine, she experienced tingling of the lip and left side of her face. She had numbness on the left side of her face. The numbness was not in her throat but it was on her neck behind her ear. Her blood pressure spiked. She drover herself to the emergency room. Her blood pressure was 160 something over 101. She was unable to specify the exact number. Then her blood pressure decreased to 104 over 80 something and it increased to 202 systolic. She was unable to specify the reading. She was tired on 27Jan2021 because she didn't sleep well in the hospital. She signed out against medical advice. The patient had a full work up to include a CT scan, MRI and doppler: results were not provided (unknown results). The patient wanted to know if recommendations were made in regard to taking the second dose if they have had adverse events. The patient was hospitalized from 26Jan2021 to 27Jan2021 (1 day) for tingling of lip and face, numbness on left side of face and blood pressure spiked. Chest pain was considered medically significant by the reporter. The outcome of she didn't sleep well was unknown. The patient was recovering from tingling of lip and face and tired. The patient has not recovered from numbness on left side of face. The patient recovered from blood pressure spiked and chest pain on 27Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
75 2021-02-11 weakness Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next... Read more
Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next day had class collapsed and stubbed toe, bleeding etc. ambulance came and assessed, PT felt so weak could not stand but was declared ok to drive by emt, got home and collapsed on the floor and crawled around for 6 days, lived on boiled eggs and rice cakes, doctor said call an ambulance, ambulance picked her up and took her to hospital, hospital took care of her for 16 days, got discharged yesterday (2-9-2021)
75 2021-02-11 weakness On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed ... Read more
On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed away.
75 2021-02-13 numbness, tingling Patient presented on 1/24 with acute onset weakness and numbness of the left leg so a stroke alert w... Read more
Patient presented on 1/24 with acute onset weakness and numbness of the left leg so a stroke alert was activated. NIHSS 3. Head Ct and CTA head/neck were unremarkable. Not a candidate for tPA given on Eliquis. Initial exam was notable for weakness and sensory loss in the left leg, but a sensory level was also found to the umbilicus raising concern for a myelitis. Of note, the patient also reported that certain red colored things she looked at appeared black. Labs unrevealing- CBC, CMP unremarkable. ESR, CRP normal. UA and UCx positive for E. Coli UTI, she was treated with ceftriaxone. MRIs were done of her brain, cervical and thoracic spine which were unrevealing. On 1/25, her exam worsened including worsening weakness in the left leg and new numbness and paresthesias in the right leg. Reflexes were preserved. MRI L spine was done which was unrevealing. Lumbar puncture was done which showed 2 nucleated cells and mildly elevated protein at 50, but was otherwise unrevealing. IgG Index normal. No oligoclonal bands. She developed mild hyperreflexia in the left leg and continued to have a sensory level, now at around T5-6. Repeat imaging of her cervical and thoracic spine were completed on 1/28 which showed a contrast enhancing hyperintensity at T5. The patient was diagnosed with myelitis and she was started on IV methylprednisolone x5 days and sent to rehab. Patient is now significantly improved though continues to report some numbness in the left leg.
75 2021-02-14 weakness, difficulty speaking sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just k... Read more
sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just kind of foggy; This is a spontaneous report by a contactable consumer (patient). This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left upper arm on 20Jan2021 07:30 for Covid-19 immunisation. Medical history none. There were no concomitant medications. The patient experienced headache on 26Jan2021 with outcome of unknown, don't feel well in Jan2021 with outcome of unknown, weak in Jan2021 with outcome of unknown, nauseated in Jan2021 with outcome of unknown, sore throat on 28Jan2021 with outcome of not recovered, hoarse in Jan2021 with outcome of unknown, she feels tired in Jan2021 with outcome of not recovered, her mind is just kind of foggy in Jan2021 with outcome of unknown.
75 2021-02-21 pain in extremity Patient self-reported left arm pain traveling down her arm after second dose of covid vaccine (pfize... Read more
Patient self-reported left arm pain traveling down her arm after second dose of covid vaccine (pfizer) administration. Patient has documented history of anaphylaxis with IV contrast. EMS on-site provided cardiac monitoring. Observed elevated BP.
75 2021-02-21 tremor Severe shaking during teh night with chest congestion and headache. Resolved by teh following day at... Read more
Severe shaking during teh night with chest congestion and headache. Resolved by teh following day at 3pm
75 2021-02-21 weakness, pain in extremity Sore arm; Temp of 100 for 2 days; general aches; fatigue; zero energy; headache on day 3
75 2021-02-21 flushing, tremor flush in face, shakiness. facial redness noted. Pt has numerous allergic rxn hx: 5x worsening. sent... Read more
flush in face, shakiness. facial redness noted. Pt has numerous allergic rxn hx: 5x worsening. sent to ED for evaluation and montioring. BP 141/76 HR 84 02 97
75 2021-02-22 discomfort Patient called stating she received the second Pfizer vaccine on 2/21. That evening, she developed s... Read more
Patient called stating she received the second Pfizer vaccine on 2/21. That evening, she developed severe generalized weakness. She was unable to walk or stand. She laid on the floor from 2/21 3pm until 2/22 PM. She was incontinent of urine- reports urinating on towels throughout yesterday. She was unable to hold her head up due to weakness. She still feels weak today, but is able to stand and walk with husband's assistance. Also reports generalized muscle soreness and intermittent vertigo. She is drinking fluids well, has eaten a light meal today. Denies fever, shortness of breath, chest pain, palpitations.
75 2021-02-22 tremor Severe shakiness - muscle weakness in legs Symptoms still persist today
75 2021-02-23 pain in extremity 2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging... Read more
2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging, itchy, and noted right above the swollen are three red areas size of tip of my pinky. (these redish spots same on my first vaccination). A few hours after I took my temp and was 99.1. I double checked and 99.1. I took one Motrin for fever and couple hours no fever. Today 2/24= Lump swelling decreased and warm to touch. I have been applying Hydrocortisone Cream 1% for mild itching.
75 2021-02-23 facial paralysis, weakness Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of a... Read more
Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (lot number: EL9262), via an unspecified route of administration, at arm left, on Jan2021 at single dose for COVID-19 immunisation. Medical history included Prediabetes from 2019 (reported as diagnosed two years ago), overweight from an unknown date, ongoing arthritis from 2017 (reported as about 4 years ago), gets worse now. There were no concomitant medications. Caller states she just has a question, states she took the test about 2 weeks ago, clarifies the Pfizer vaccine and due for next one on Sunday, caller wanted to find out if what she experienced could be due to the vaccine, states she had a reaction for almost two weeks (also reported that all the events started on 05Feb2021, pending clarification), states her blood pressure went up, she had chest pain in her chest, weakness, loss of appetite, states it lasted about 24 hours, no exact dates provided. Also experienced Bell's Palsy states it comes and goes, that when she talks the saliva comes down the side of her mouth. States her Blood pressure went really high, 145/90 or so, lasted about 24 hours. Did not know if she was having a heart attack. Does see a cardiologist because of a family history of cardiac issues. The outcome of the event Bell's Palsy was not recovered, of the other events was recovered on Jan2021 (reported as lasted for 24 hours).
75 2021-02-23 night sweats Evening Feb. 15, chills, fever, muscle aches, and headache and exhaustion. Night sweats with tem... Read more
Evening Feb. 15, chills, fever, muscle aches, and headache and exhaustion. Night sweats with temp. up to 101.8. Day temps 99 to 100. Have lasted to the present time. Treatment fluids and aspirin. Chest x-ray and urinalysis clear. Covid nasal test yesterday, Feb.23. The second Pfizer vaccine scheduled for today, Feb. 24, was cancelled.
75 2021-02-23 pain in extremity Got the vaccine, and on 2/22/21 she woke up at 2-3:00 AM with violent vomiting, two episodes. Her a... Read more
Got the vaccine, and on 2/22/21 she woke up at 2-3:00 AM with violent vomiting, two episodes. Her arm was sore, still having nausea. She feels like she is going to throw up still, 2/24/21. She has not taken anything for the symptoms.
75 2021-02-24 tremor Day 2: flu like symptoms. W/o fever. Confined to bed Day 3: same but part time in bed Day 4: redu... Read more
Day 2: flu like symptoms. W/o fever. Confined to bed Day 3: same but part time in bed Day 4: reduction in flu like symptoms but disoriented and lethargy and headache Day 5: disoriented and lethary Day 6: same Day 7: shakey and lethargic Day 8: same
75 2021-02-24 burning sensation VR stated burning sensation through neck and up into head. VR noted fatigue within 5 min of vaccinat... Read more
VR stated burning sensation through neck and up into head. VR noted fatigue within 5 min of vaccination. Observed for an extra 15 min. vitals stable. symptoms subsided within 5 min of onset
75 2021-02-25 weakness Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started hav... Read more
Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started having a sharp chest pain on drive home. She pulled over and the feeling went away. No other symptoms. On sat morning patient started getting twinges of chest pain on left side bottom by her breast. On Saturday night and Sunday morning patient started belching. She doesn't normally have belching. This morning patient felt like her heart racing. She is still having a chest pressure. Was sent to ED 2/8/21 after triage. Labs unremarkable, troponin negative, instructed to f/u with PCP, discharged in stable condition. F/U w/ PCP 2 weeks later and reported weight loss, weakness, possible facial droop (although not noticed today on exam). Symptoms appear to be improved.
75 2021-02-25 weakness, tremor Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sin... Read more
Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sinuses, red burning eyes, constant sneezing and dripping nose, weak and shaky on my feet. Lose of appetite, constipation and nausea.. It lasted for 4 days and on Wednesday I called my medical care giver and she said that I probably had an allergic reaction to the vaccine and to not take the next dose, as this had been my first. I am still, periodically week and dizzy, and still have little appetite.
75 2021-02-27 nerve pain Had no pain in arm or redness for the first 10 days. Developed severe pain in my arm from the injec... Read more
Had no pain in arm or redness for the first 10 days. Developed severe pain in my arm from the injection sight up to my ear and neck. The pain in my neck stayed for 9 days with pain to my arm that was terribly painfull. Now I still have an ache in my neck and arm that is mild but also feels very tired like if you had a neck injury from nerve pain
75 2021-02-27 flushing Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feel... Read more
Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feeling pressure in the head I have observed Patient having red face itchy face foggy pressure in the head. Vital signs: 0843 BP 170/80 HR 96 RR 18 Pulse Ox 98% 0846 BP 182/80 0857 BP 168/84 HR 88 RR 16 Pulse Ox 97% 0910 BP 180/90 HR 88 RR 16 Pulse Ox 97% 0925 BP 200/90 HR 88 RR 16 Pulse Ox 97% Treatment/intervention Monitored offered water Benadryl 25 mg po @ 0850 by an RN, Benadryl 25 mg po @ 0914 by an RN 0925 patients BP continued to be out of normal range patient stated that she took her BP medications this am. Face still flushed. 0925 ambulance called to transport patient to the ED. 0925 ambulance her report given.
75 2021-02-27 burning sensation, weakness, tingling, numbness, night sweats Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of ... Read more
Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of feet, muscle weakness, dry mouth, joint pain, headache,...
75 2021-02-28 feeling cold On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a ... Read more
On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a fever; slept for 15 hours; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 17:00 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse and COVID-19. Concomitant medication included bimatoprost (LUMIGAN), colecalciferol (D3), zinc (ZINC), and ubidecarenone (COQ10). The patient experienced severe muscle ache, severe headache, nauseous, so cold (could not get warm), had a fever and slept for 15 hours on 26Jan2021 21:00. The patient received no treatment. The outcome of the events was recovered with sequelae on an unspecified date.
75 2021-02-28 tingling Pt developed left lower lip paresthesia that radiated to L side of face.; Pt developed left lower li... Read more
Pt developed left lower lip paresthesia that radiated to L side of face.; Pt developed left lower lip paresthesia that radiated to L side of face.; This is a spontaneous report from a non-contactable pharmacist. A 75-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular on 26Jan2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included transient ischaemic attack (TIA), stroke and chronic kidney disease (CKD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took gabapentin for facial nerve pain. The patient developed left lower lip paresthesia that radiated to the left (L) side of face on 26Jan2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
75 2021-02-28 pain in extremity, muscle spasms Severe knee and leg pain, spasms and swelling in the knee and ankle on just one leg. . Started two d... Read more
Severe knee and leg pain, spasms and swelling in the knee and ankle on just one leg. . Started two days after receiving the Covid19 vaccine. Great difficulty walking. without assistance. Pain began to subside on the fourth day and is less intense today, the fifth day following vaccination but is still present.
75 2021-03-01 numbness Transverse myelitis; bowel and urine issues; bowel and urine issues; she can't walk; numbness from h... Read more
Transverse myelitis; bowel and urine issues; bowel and urine issues; she can't walk; numbness from her toes up to her breast on the left side and numbness from her toes to her groin on the right side; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 at 13:00 at single dose into right arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EL8982. Medical history was unknown and concomitant medications included blood pressure pills and cholesterol pills and vitamins. On 24Jan2021, the patient experienced transverse myelitis; the patient was hospitalized due to the event (hospitalization dates from 24Jan2021 to 7Feb2021; emergency room since 24Jan20211 noon). Consumer stated that when she was in the hospital, she was on heavy doses of steroids intravenous (IV) for 5 days. Blood work at the hospital was normal. Consumer left the hospital to go to the rehab facility on 30Jan2021, and then consumer left the rehab facility on 07Feb2021. Consumer stated that she could not walk. Consumer had complete numbness from her toes up to her breast on the left side and numbness from her toes to her groin on the right side. Consumer stated that she was still having issues with dragging her left leg, and with rehab, she was finally getting back some feeling, the numbness was still there but she was having bowel and urine issues. Consumer stated that her issues have somewhat improved with the help of rehab. The patient was recovering from the events.
75 2021-03-02 tingling AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarifie... Read more
AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.
75 2021-03-02 weakness Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This ... Read more
Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received first dose BNT162B2 (Solution for injection, Lot number: EL9264) via an unspecified route of administration on 31Jan2021 16:00 at single dose in right arm for covid-19 immunisation. Medical history included breast cancer and hodgkin Lymphoma. Concomitant medication included simvastatin, vitamin d nos. The patient had extreme tiredness, nausea, feeling like I was run over by a truck, chills, headache, weakness on 01Feb2021 at 13:00 pm. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. The outcome of the events was recovering.
75 2021-03-02 flushing Patient experienced chills and flushing minutes after vaccine administration. Vital Signs stable. Sp... Read more
Patient experienced chills and flushing minutes after vaccine administration. Vital Signs stable. Spontaneous improvement. No medications offered.
75 2021-03-03 bell's palsy Bells Palsy-treated with Prednisone
75 2021-03-03 tingling Following second dose of COVID 19 vaccine patient developed SOB with 4-5 word dyspnea and increased ... Read more
Following second dose of COVID 19 vaccine patient developed SOB with 4-5 word dyspnea and increased work of breathing. Pt. also complained of tingling in bilateral lower extremities. Pt. also noted with hypertension and bradycardia (beta blocker therapy). She was given Zyrtec 10mg po without resolution of symptoms within 30 minutes. Pt. then received IM Epi-Pen. Pt. remained alert and appropriate with on-going SOB when EMS arrived to transport to local ED. Medical response was activated for this event.
75 2021-03-04 weakness My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe head... Read more
My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe headache. As the night continued on she had fever chills that would come and go all night causing her not to get much sleep. Day two the chills were gone but still very achey, weak, tired and headache. Day three she is still tired and weak with headache.
75 2021-03-04 weakness Patient reports a burning sensation in her chest, weakness, and fatigue. States this started Wednes... Read more
Patient reports a burning sensation in her chest, weakness, and fatigue. States this started Wednesday following the vaccine.
75 2021-03-04 seizure Patient's son reported that patient had a seizure on 3/5/21 after receiving the second Pfizer-BioNTe... Read more
Patient's son reported that patient had a seizure on 3/5/21 after receiving the second Pfizer-BioNTech vaccine on 2/24/21.
75 2021-03-04 tremor chills to where body was shaking, headache, tiredness, hard to get out of bed, just not feeling well... Read more
chills to where body was shaking, headache, tiredness, hard to get out of bed, just not feeling well . This lasted a day, feel better today
75 2021-03-07 cold sweat Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms;... Read more
Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.
75 2021-03-08 muscle spasms Back pain; extremely painful back muscle spasms; minor pain; This is a spontaneous report from a con... Read more
Back pain; extremely painful back muscle spasms; minor pain; This is a spontaneous report from a contactable consumer (patient). A 75 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265), via an unspecified route of administration (on right arm) on 30Jan2021 12:30 (at the age of 75 -years-old), single dose for COVID-19 immunization. Concomitant medication included levothyroxine sodium (L THYROXINE), rosuvastatin, magnesium. Back pain, extremely painful back muscle spasms. Started minor pain 3 days after vaccine didn't associate it with vaccination, very painful and spasms on day 6. Have not had any back injury or strain that patient was aware of. It was reported that adverse events started 04Feb2021 19:00. Patient just wanted to be sure if ok to take 2nd vaccination. The outcome of the events was not recovered. No treatment given for any of the adverse events. The events were assessed as non-serious by the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
75 2021-03-08 pain in extremity arthritis; fingers on right were all swollen; she could barely move her arm; right hand and wrist wa... Read more
arthritis; fingers on right were all swollen; she could barely move her arm; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; light headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unspecified route of administration on 26Jan2021 at 10:40 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included arthritis from an unknown date, renal cancer since 07Dec2020 and ongoing, atrial fibrillation since 2006 and ongoing, partial nephrectomy on 06 Jan2021. She specified that she has an arthritis flare up about once a year and normally takes a Medrol dose pack. The patient's historical vaccines included an unspecified flu vaccine (MANUFACTURER UNKNOWN) on an unspecified date about ten years ago after which she had to go to the Emergency Room for right arm redness, swelling at the injection site and face swelling on right side. She did not get another flu shot for 10 years but did get one this year in Nov2020. Concomitant medication included metoprolol (MANUFACTURER UNKNOWN), flecainide acetate (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN, MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports that she experienced a light headache. She clarified that she is in an unspecified program which includes an e-diary. As part of that program (app) she was sent a text every day for a week asking if she had any side effects; a couple times she had a headache. On the eighth day (03Feb2021) she had a reaction where her right hand and wrist was painful and swollen. Caller states she couldn't move her hand without pain. Caller states she put ice on her hand Wednesday evening and this helped a little. When ice was on her hand it helped with the pain but when it was removed it came back. She also reported fingers on right were all swollen and that she does have arthritis. She further described the events as on Wednesday she started getting a little pain in her right wrist joint. She does have arthritis, but this pain was stronger, and her hand and fingers on right were all swollen in comparison to her other hand, and her knuckles seemed bigger. States that the pain got very strong and by the next morning she could barely move her arm; even though it was only her wrist that hurt, moving any part of her arm made her wrist her more, so she started icing it and took Tylenol for Arthritis 650mg Extended Release; she took it twice, one each time and reported that it probably didn't work. Caller clarifies statement about it probably not working; stating that she didn't notice a difference after taking the Tylenol. She asked if these events, occurring eight days after the vaccine could be vaccine side effects or is this just a flare up on her arthritis that is unrelated to the vaccine. She added that she had been doing a lot of "chopping" while cooking on the night that this happened so that may have caused the flare up. She has a Medrol pack on hand for things like this (4mg tablets). She started it today and took two tablets before breakfast and one tablet at lunch. She states that it has already made a difference in her pain. She stated her concern, however, which is that she found that taking a steroid could affect the vaccine if taken before getting the vaccine, and right now she is in-between the two doses. Her second dose is scheduled for 16Feb2021. She inquired as to if she can finish this dose pack without messing up the vaccine. The clinical outcome of headache was reported as recovered. The clinical outcomes of hand swelling, wrist pain, hand pain and swelling of wrists were reported as not recovered. The clinical outcomes of arthritis flare up, swelling of fingers and could not move her arm were unknown.
75 2021-03-09 pain in extremity Severe arm pain going down to hands and fingers.; could not unfold elbow or arm due to pain; She cou... Read more
Severe arm pain going down to hands and fingers.; could not unfold elbow or arm due to pain; She could not dress b/c the feeling of clothing in arm was excruciating.; This is a spontaneous report from a consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (lot/batch number and expiration date were unknown) via an unspecified route of administration at left arm on 02Feb2021 08:00 at single dose for covid-19 vaccine. Medical history included diabetes and hypertension. Unspecified concomitant medication used in two weeks. There was no known allergies. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. The patient had severe arm pain going down to hands and fingers on 02Feb2021 at 18:00. She had severe sensitivity. She could sleep due to pain but could not unfold elbow or arm due to pain. She could not dress b/c the feeling of clothing in arm was excruciating. She was in tears. It was been about 5 days and the pain and sensitivity has increased every day. Patient had taken paracetamol (Tylenol), ibuprofen (Advil) went to my primary and got prescribed tramadol for pain. Nothing was helping. Patient visited doctor or other healthcare professional office/clinic visit due to events. She did not have COVID tested post vaccination. The outcome of events was not recovered. Information on batch number has been requested.
75 2021-03-11 weakness Nausea, vomiting, fever, generalize weakness, dehydration
75 2021-03-14 pain in extremity A sore arm/just kind of sore; This is a spontaneous report from a contactable consumer. A 75-years-o... Read more
A sore arm/just kind of sore; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3247 with expiry date: 31May2021) via an unspecified route of administration on 28Jan2021 at single dose for Covid-19 immunization. The patient's medical history included high blood pressure which was well controlled, diabetes controlled upon her diet, due to arthritis she don't walk really fast and she has go to physical therapy for it. Consumer stated, well I got the first Pfizer vaccine (clarified as COVID 19 vaccine) on 28Jan2021. I got it and I am just fine I got it in (place name), then I noticed on here I had no awful side effect whatsoever, what was the likelihood with that of having the awful side effect with the second vaccine. When probed to clarify if experienced any side effect, Consumer stated, It was just kind of sore (sore arm) but nothing awful at all. She also stated she took second doe on 18Feb2021. Consumer further stated, I just wanted to know what are the chances were because one of my friend got the AstraZeneca and she didn't have it either any symptoms after the first injection but after the second one she did it was more likely to occur after the second vaccination. The outcome of event was unknown. No follow-up attempts are possible. No further information was provided.
75 2021-03-14 pain in extremity Red bump on my forehead; it feels like kind of sore when I touch it; Red bump on my forehead; it fee... Read more
Red bump on my forehead; it feels like kind of sore when I touch it; Red bump on my forehead; it feels like kind of sore when I touch it; She is getting red bumps today on the part where she got injected; Sore arm; I get this pain in my pointer finger in my right hand; A little weakness in my right leg; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 75-years-old) as a single dose for covid-19 immunisation. Medical history included high blood pressure, osteoporosis and overactive bladder. The patient concomitant medications were not reported. The previously had first dose (first shot) of BNT162B2 for covid-19 immunisation and had sore arm. It was reported that she is getting red bumps today (on 07Feb2021) on the part where she got injected. The consumer stated after second shot also, I had no symptoms except for sore arm on an unspecified date in Feb2021. The only thing that I noticed which was from second shot and which was really crazy is, once in a while I get this pain in my pointer finger in my right hand and that was it, it comes and it goes. But today, and in the last couple of days I noticed a little weakness in my right leg, but today when I went to work somebody said what is that big red bump on your forehead and I looked and there was a big red circle, there was a bump, like a real bump on my forehead. I didn't hide it, I didn't even think if it was allergic as I only had a banana before I went to work and a cup of coffee which I have lot of time. I am wondering if this bump that I have on my forehead which looks ridiculous and it is a big red bump, like a tumor bump, it feels like kind of sore when I touch it, is from the vaccine because I haven't had anything but the vaccine." Consumer stated, "Main thing I am concerned about is the big red bump on my forehead." Treatment: Consumer stated, "I never had that before, it is very slight. The main thing was the bump on my head that came today and I didn't have it when I left the house. I didn't hit my head or anything. I just took two Tylenol and an allergy pill in case if it was some kind of allergy." The outcome of the events was unknown. Information on the lot/batch number has been requested.
75 2021-03-18 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female... Read more
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), (at the age of 75-year-old) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure, osteoporosis, Overactive bladder. The patient received second shot on the 06Feb (not clarified). After the first shot, the patient had no symptoms except for sore arm. The outcome of the event was unknown. Information on the lot/batch number has been requested.
75 2021-03-20 pain in extremity Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen ... Read more
Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen lymph nodes that hurts like crazy; Swollen lymph nodes that hurts like crazy; arm got sore; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31May2021), via an unspecified route of administration on 03Feb2021 (at the age of 75 years) as single dose for covid-19 immunisation; potassium chloride (KLOR-CON M10), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included ongoing type 2 diabetes and ongoing high blood pressure. Concomitant medications included metformin; atorvastatin; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Consumer stated she got her Covid inoculation last Wednesday and in Feb2021, she was experiencing symptoms, adverse reactions. She had injection site pain still, muscle pain, her lungs are fine but when she breathe her front and back of her chest hurts. She had chills. She did not think she had a fever but she was definitely feeling unwell and the most difficult thing was swollen lymph nodes that hurts like crazy. She cannot read this too well. Lot was 2CI or EI EL3302 expires 31May2021. Her arm got sore but today she really started may be yesterday experiencing this muscle pain and the lymph stuff going on. Consumer stated she had no treatment. The last time her doctor gave her this new medication because she had run out of her potassium. It was called Klor-con M10 tablet. For lab work, consumer stated she did not know but right before she went there they took some blood and when the doctor gave her the Klor thing, she had a violent reaction to it. she threw up and had a lot of diarrhea and she have not taken it since. Results of lab work was unknown. The action taken in response to the events for potassium chloride was unknown. Outcome of events was unknown. Information about lot/batch number has been requested.
75 2021-03-21 weakness Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chil... Read more
Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chills, weakness and acute confusion ~ 3 days prior to admission. Placed on NIPPV, steroids, convalescent plasma and antibiotics. Patient died 2/24/2021
75 2021-03-24 weakness She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, an... Read more
She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better. About 12 hours later she had a headache and took some Aleve. She woke up the next morning with a severe headache and chest pain that was excruciating. Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis. They sent her home with steroids and Colchicine. They did not want to put her on NSAIDS due to possible ulcers. She all the COVID symptoms, and had severe pain still. Her daughter 3 weeks later took her to the cardiologist. She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine. She was then sent to the ER again, and went there twice. He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues. They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter. She is now back in sinus rhythm. She was advised not to get the 2nd vaccine due to the reactions from the first one. She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.
75 2021-03-28 unresponsive to stimuli Cardiac arrest witnessed by family. Pt became SOB at home and became unresponsive. CPR was started b... Read more
Cardiac arrest witnessed by family. Pt became SOB at home and became unresponsive. CPR was started by family. Pt was in asystole, intubated, given two rounds of epinephrine in the field. Pt was on autopulse and ROSC was achieved around 0125. Pt was seen at ER and was transferred to Hospital.
75 2021-04-04 weakness Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised ... Read more
Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised to hold blood pressure medication. On 3/8, was feeling much worse and called 911. Upon arrival (8:55), patient A&O x 4 with poor oxygen saturation (O2: 88%). Given nebulized albuterol/ipratropium. BG: 247mg/dl. Patient has episode of dry heaving after which she vagaled down with HR in the 40s. Recovered on her own. Once the nebulizer treatment ended, she was place on nasal O2 at 3 liters/minutes. Given 4mg ondansetron. Lost consciousness and respirations became agonal. Pt was bagged via BVM and noted to be in PEA. CPR initiated, including intubation. Given 1mg epinephrine. NSR obtained after two rounds of CPR. Pt arrested again shortly after arrival to ED. ACLS initiated once more. Patient expired at 10:40 am.
75 2021-04-17 weakness Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't mo... Read more
Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't move/tiredness; weakness; bleeding; Test: Iron; Result: Critically low; red blood cell was below 5; administered at the left upper forearm; This is a spontaneous report from a contactable nurse (patient) via Pfizer. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left upper forearm on 01Mar2021 at the age of 75-years-old as single dose for COVID-19 immunization. The vaccine was administered to the patient at a pharmacy (in a grocery store). The patient had no prior vaccinations (within 4 weeks). The patient's medical history included retired (retired registered nurse), ongoing depression (has had this condition for probably 20 years), ongoing lung cancer (has had this condition for probably 3 years), ongoing bipolar (has had this condition for about 4 years), ongoing emphysema (has been severe for about 4 or 5 years), and ongoing chronic obstructive pulmonary disease (COPD) (has been severe for about 4 or 5 years). Concomitant medications included duloxetine taken for depression from an unspecified start date and ongoing (been taking this probably for 15 years); and arformoterol tartrate (BROVANA) (started taking this probably 5 years ago), budesonide (started taking this probably 5 years ago), tiotropium bromide (SPIRIVA) (has been taking this for probably about 4-5 years), oxygen (has been using this full time for 3 years), and Trilogy machine (she sleeps with this, it is an invasive intubation. She puts a big mask on and it pumps air in, pulls air out, letting her lungs rest. Her oxygen hooks up to it), all taken for emphysema and COPD from an unspecified start date and ongoing. The patient reported that she received the vaccine on 01Mar2021 and sometime in Apr2021 around Easter, she went to the hospital for COPD exacerbation, tiredness and weakness. The patient required a visit to the emergency room due to the events and reported that she went by ambulance to the hospital. The patient stated that she has these events often and it has nothing to do with the COVID vaccine. She went to the hospital with exacerbation of COPD and missed her date to get her last shot. She wanted to know whether she can get the 2nd dose of the vaccine with her experience after the 1st dose. The patient reported that she now weighs 177 after she has been pumped full of cortisone. The patient reported that her lung doctor was really the one that manages her medical. The patient reported that she thinks she came home from the hospital the day before Easter and she was in the hospital for 5 days (in Apr2021). She was sick before that, at home, and she finally had to call # to come and get her. She believes she had to call # the 5th day before Easter, but she was not positive. When asked to clarify what she meant by sick, the patient explained she was extremely tired, she couldn't get out of bed and couldn't move. She was having trouble breathing. She was on oxygen 24/7 and sleeps with a trilogy machine so she was having a lot of trouble, it was awful. She said she then found out at the hospital her red blood cell was below 5 and her iron was critically low. They had to give her 2 units of blood and an infusion. Then she went back yesterday and got another infusion and she has to go back next week for another infusion. The patient confirmed that she was hospitalized for COPD. She then stated she didn't know the exact date of when she was discharged from the hospital, but she was thinking it was the day she was scheduled for her second shot. She then clarified she came home Easter. The patient reported that she can't do much without having to sit down, catch her breath, and rest a little bit. She was improving but not as fast as she'd like to. While reading the vaccine record card, the patient stated "my eyes aren't as good as they used to be". Her pulmonologist stated she was going to die if she doesn't take the vaccine. If she catches COVID she was not going to make it, so her pulmonologist thinks her chances are better with the vaccine than without it. The patient said she goes all the time to the hospital; therefore, she doesn't think the events were related to the vaccine. She had been sick several times. They can't do anything about the bleeding, they can't go in to do anything because of her lungs, her lungs were so bad. No further details were provided regarding the bleeding she was speaking of. The patient reported that duloxetine doesn't come as 90 mg so she takes a 30 mg and 60 mg tablet; she mixes the Brovana and Budesoind and takes them at the same time, twice a day. She was given an albuterol solution, 0.5mg PRN (as needed), for her emphysema/COPD. She says she just started taking this from her last hospital stay. The patient reported that she did not remember her iron count, just that it was critically low. She did remember asking the nurse what could happen, and the nurse said a lot of things such as infection. She confirmed tests were done in regards to the lung cancer. Her lungs were too critical for any kind of invasive tests. It was reported that the events Exacerbation of COPD and "extremely tired, couldn't get out of bed, couldn't move" were assessed by the patient as unrelated to BNT162B2. The outcome of the events "Exacerbation of COPD/having trouble breathing" and " extremely tired, couldn't get out of bed, couldn't move/tiredness" was recovering, while the outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, the reported events Chronic Obstructive Pulmonary Disease, Fatigue, Asthenia, Blood iron decreased, Red blood cell count decreased and Asthenia are assessed as intercurrent medical conditions and unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
75 2021-04-17 pain in extremity Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really so... Read more
Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really sore; Some choking; Anxiety; Cough during treatment; This is a solicited report (MARKETING PROGRAM NAME NOT AVAILABLE) based on the information received by Pfizer pharmacy. A contactable 75-year-old female consumer (patient)received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation; and treprostinil sodium, via inhalation from 12Feb2021 (Batch/Lot number was not reported) to an unspecified date and at 18-54 ug, 4x/day, via inhalation from an unspecified date (Batch/Lot number was not reported), at 36 ug, 4x/day for pulmonary arterial hypertension. Medical history included ongoing anxiety. The patient's concomitant medications were not reported. In Feb2021, the patient experienced event of cough during treatment. In 2021, the patient experienced event of gagging (retching). On 04Mar2021, the patient experienced event of anxiety; related it to going to the physician appointment. An additional dosage regimen of 36 ug (6 breaths), qid via IH route was added to Tyvaso. The patient reported that coughing (previously reported as cough) and gagging had improved after the treatment. The patient's current IH Tyvaso dose was 6 breaths four times a day. On 04 Mar 2021, 2 weeks 6 days after initiating IH Tyvaso, the patient had anxiety and related it to going to the physician appointment. The patient had reported ongoing anxiety since childhood. In 2021, the patient experienced the event of some choking. In 2021, the patient experienced the events of feels tired and sleepy all the time and arm was really sore (pain in extremity). The patient felt tired and sleepy all the time. Her arm was really sore and she was tired and sleepy. The outcome of the event cough and gagging was recovering while the outcome of the rest of the events was unknown. The action taken in response to treprostinil sodium for the events was unknown. An unspecified treatment was given to the patient for the event cough and gagging. The reporter assessed the causal relationship between the IH Tyvaso and the event of cough as possible. The reporter did not provide causality for the events of retching, choking, anxiety, fatigue, somnolence, and pain in extremity. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of choking,cough,gagging,and other events cannot be excluded but also contributory effect from other suspect drug TREPOSTINIL SODIUM. consider also possible contributory effects from patient's medical history and concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
75 2021-04-17 feeling hot cellulitis; Bacterial skin infection; right arm where I got the injection turning all red and swolle... Read more
cellulitis; Bacterial skin infection; right arm where I got the injection turning all red and swollen; arm swelling; bursitis; Muscle pain; joint pain in elbow; the bruise have been flamed; Feeling hot; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 75-years-old, via an unspecified route of administration in right arm on 13Mar2021 at single dose for COVID-19 immunization. Medical history included diabetic type 2 for probably 13-14 years, sleep apnea for 20 years (2001), arthritis in 2005 (probably 12-14 years), and blood pressure abnormal (reported as blood pressure). Concomitant medications included metformin, sertraline, alprazolam, sitagliptin (JANUVIA), oxybutynin, insulin glargine (LANTUS), lisinopril for blood pressure abnormal (reported as blood pressure), and cortisone for arthritis. The patient received the vaccine on 13Mar2021 in the afternoon and within 24 to 30 hours, the next day (14Mar2021), her right arm, where the vaccine was administered turned all red and swollen and her elbow also hurt. She went to the emergency room because she felt it was a reaction to the vaccine. They told her that it was a bacterial skin infection, an adverse effect of an initial encounter to the vaccine, arm swelling and bursitis caused by that, muscle pain and join pain in elbow and then she guessed it was like cellulitis. They gave her ROCEPHIN at the emergency room and then a couple days later, it wasn't getting any better and it was all the way down to her wrist. She went to immediate care center and received an antibiotic. She was also given 2 more prescription of antibiotics and told that it had to be administered with the antibiotics to get rid of the reactions. It has finally pretty much cleared up with the antibiotics if they hadn't put her in an immediate care and put her on intravenous medications. They were really concerned because it was going to get into sepsis or something. At first, the patient thought that it was just inflamed, then it was skin infection and then adverse effect from the initial encounter of the vaccine. She had been on the antibiotics for 10 days when it finally cleared, but the elbow was still sore and it hurts a lot, but the fluid was drained by an orthopedic doctor. She was given 2 different types of antibiotics plus a shot into her buttocks. It's a little sore because she was informed that "the bruise have been flamed" on Mar2021. When she went to emergency, first they give her 1 gm ROCEPHIN and then switched antibiotic to DURICEF and to BACTRIM DS, and advised to continue monitoring and if swelling and redness was progressive or worse, then go to emergency room again. She went to emergency room on 16Mar2021, the medicine given was doxycycline and then she was seen by an orthopedic physician today where the fluid was drained from her elbow but swelling and redness was progressively getting worst and she was feeling hot on Mar2021. So, she went to the immediate care. Overall, consistent to cellulitis of right upper arm strongly includes to go to the ER but the patient had something else and had to go right then. And then, she was given 1 gm ROCEPHIN and then switched to DURACEF and BACTRIM. She came back to the ER on the same day. It was kind of 2 things, like the redness and skin infection which currently was cellulitis. Doxycycline was what they told her to get, that's what they gave her at the emergency room, doxycycline hyclate. And then said to follow-up with her primary care which she did and that was on 17Mar2021. She looked at it and then they told her to see an orthopedic surgeon and she saw him on the 18Mar2021. They just thought that the antibiotics, that's why he gave her 2 different prescriptions plus the shot in the buttocks because he said if this will not be cured with the antibiotics, she'll end up in a hospital. And then it was raft and it took her 10 days to recover. And he marked little black dots to show where wasn't and if it goes beyond that then call us because it was spreading. The outcome of the events bruise and feeling hot was unknown, not recovered for joint pain, and recovered on 24Mar2021 for all other events. The events required emergency room visit/ physician office visit.